Appendix D
Table
43. Status of Submissions by American Association for the Advancement
of Wound Care
Table 44. Status of Submissions by Kinetic
Concepts, Inc.
Table 45. Status of CMS submission: Publications
Table 46. Status of CMS submission: Government
Documents
Table 47. Status of CMS submission: Miscellaneous
Material
Table 48. Status of CMS submission: Material
from KCI or related to KCI
Table 49. Status of CMS submission: Material
from BlueSky or related to BlueSky
Table 50. Status of Submissions by Prospera
Table 51. Status of Submission by ConvaTec
Table 52. Status of Submission by Individuals
Table 53. Status of Submission by Medela
Table 54. Status of Submission by Talley
Group, Ltd.
Table 55. Status of Submissions by Smith
and Nephew
Figure 5. Disposition of Documents Submitted by Interested Stakeholders
![Select [D] below for text description.](npwtdfig5.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect screening of
meeting abstracts, poster presentations and other documents
in addition to abstracts and full articles.
Figure 6. Disposition of
Submission by American Association for the Advancement of Wound
Care
![Select [D] below for text description.](npwtdfig6.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Table 43. Status of Submissions
by American Association for the Advancement of Wound Care
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not Identified
in ECRI Search |
| (390) |
Abai B, Zickler RW, Pappas PJ, Lal BK, Padberg
FT Jr. Lymphorrhea responds to negative pressure wound therapy.
J Vasc Surg 2007 Mar;45(3):610-3. |
|
|
√ |
Fewer than five patients |
|
| (152) |
Adamkova M, Tymonova J, Zamecnikova I, Kadlcik
M, Klosova H. First experience with the use of vacuum assisted
closure in the treatment of skin defects at the Burn Center.
Acta Chir Plast 2005;47(1):24-7. |
√ |
KQ3 |
|
|
|
| (372) |
Agarwal JP, Ogilvie M, Wu LC, Lohman RF, Gottlieb
LJ, Franczyk M, Song DH. Vacuum-assisted closure for sternal
wounds: A first-line therapeutic management approach. Plast
Reconstr Surg 2005 Sep 15;116(4):1035-40. |
√ |
KQ3 |
|
|
|
| (391) |
Agrawal S, Hayhurst C, Joseph T, Prinsloo
D, Morgan RH, Pherwani AD. Successful salvage of infected
and exposed non-absorbable mesh following decompressing laparostomy
after emergency repair of ruptured abdominal aortic aneurysm
using vacuum-assisted closure system. Eur J Vasc Endovasc
Surg 2008 Jan;15(1):1-2. |
|
|
√ |
Narrative |
|
| (392) |
Aguinaga S, Welber A, Stephens S. Positive
steps towards negative pressure wound therapy. Medsurg Nurs
2007 Jun;16(3):181-2, 189. |
|
|
√ |
Narrative |
|
| (393) |
Alvarez AA, Maxwell GL, Rodriguez GC. Vacuum-assisted
closure for cutaneous gastrointestinal fistula management.
Gynecol Oncol 2001 Mar;80(3):413-6. |
|
|
√ |
Case report |
|
| (394) |
Andrabi SI, Ahmad J, Rathore MA, Yousaf M.
Vacuum assisted closure of laparostomy wounds "a novel
technique". J Ayub Med Coll Abbottabad 2007 Jul-Sep;19(3):89-92. |
|
|
√ |
Case report |
|
| (395) |
Andrabi SI, Ahmad J. Negative pressure therapy
for laparotomy wounds--a word of caution. J Wound Ostomy
Continence Nurs 2007 Jul-Aug;34(4):425-7. |
|
|
√ |
Case report |
|
| (396) |
Andrews BT, Smith RB, Chang KE, Scharpf J,
Goldstein DP, Funk GF. Management of the radial forearm free
flap donor site with the vacuum-assisted closure (VAC) system.
Laryngoscope 2006 Oct;116(10):1918-22. |
|
|
√ |
No relevant outcomes |
|
| (88) |
Andrews BT, Smith RB, Goldstein DP, Funk GF.
Management of complicated head and neck wounds with vacuum-assisted
closure system. Head Neck 2006 Nov;28(11):974-81. |
√ |
KQ3 |
|
|
√ |
| (397) |
Andrews BT, Smith RB, Hoffman HT, Funk GF.
Orocutaneous and pharyngocutaneous fistula closure using
a vacuum-assisted closure system. Ann Otol Rhinol Laryngol
2008 Apr;117(4):298-302. |
|
|
√ |
Fewer than five patients |
|
| (398) |
Andros G, Armstrong DG, Attinger C, Boutlon
AJ, Frykberg RG, Joseph WS, Lavery LA, Morbach S, Niezgoda
JA, Toursarkissian B. Consensus statement on negative pressure
wound therapy (VAC Therapy) for the management of diabetic
foot wounds. Wounds 2006 Jun;52(6 Suppl):1-32. |
|
|
√ |
Guideline |
|
| (385) |
Antony S, Terrazas S. A retrospective study:
Clinical experience using vacuum-assisted closure in the
treatment of wounds. J Natl Med Assoc 2004;96(8):1073-7. |
√ |
KQ3 |
|
|
|
| (192) |
Apelqvist J, Armstrong DG, Lavery LA, Boulton
AJ. Resource utilization and economic costs of care based
on a randomized trial of vacuum-assisted closure therapy
in the treatment of diabetic foot wounds. Am J Surg 2008
Jun;195(6):782-8. |
|
|
√ |
Cost analysis |
|
| (399) |
Arca MJ, Somers KK, Derks TE, Goldin AB, Aiken
JJ, Sato TT, Shilyansky J, Winthrop A, Oldham KT. Use of
vacuum-assisted closure system in the management of complex
wounds in the neonate. Pediatr Surg Int 2005 Jul;21(7):532-5.
Epub 2005 Jun 17. |
|
|
√ |
Fewer than five patients |
|
| (400) |
Archdeacon MT, Messerschmitt P. Modern papineau
technique with vacuum-assisted closure. J Orthop Trauma 2006
Feb;20(2):134-7. |
|
|
√ |
Case report |
|
| (401) |
Argenta LC, Morykwas MJ, Marks MW, DeFranzo
AJ, Molnar JA, David LR. Vacuum-assisted closure: state of
clinic art. Plast Reconstr Surg 2006 Jun;117(7 Suppl):127S-142S. |
|
|
√ |
Narrative |
|
| (148) |
Argenta LC, Morykwas MJ. Vacuum-assisted closure:
a new method for wound control and treatment: clinical experience.
Ann Plast Surg 1997 Jun;38(6):563-76; discussion 577. |
√ |
KQ3 |
|
|
√ |
| (402) |
Argenta PA, Rahaman J, Gretz HF 3rd, Nezhat
F, Cohen CJ. Vacuum-assisted closure in the treatment of
complex gynecologic wound failures. Obstet Gynecol 2002 Mar;99(3):497-501. |
|
|
√ |
Fewer than five patients |
|
| (403) |
Armstrong DG, Attinger CE, Boulton AJ, Frykberg
RG, Kirsner RS, Lavery LA, Mills JL. Guidelines regarding
negative wound therapy (NPWT) in the diabetic foot. Ostomy
Wound Manage 2004 Apr;50(4B Suppl):3S-27S. |
|
|
√ |
Guideline |
|
| (404) |
Armstrong DG, Boulton AJ, Banwell P. Negative
pressure wound therapy in treatment of diabetic foot wounds:
a marriage of modalities. Ostomy Wound Manage 2004 Apr;50(4A
Suppl):9-12. |
|
|
√ |
Narrative |
|
| (194) |
Armstrong DG, Kunze K, Martin BR, Kimbriel
HR, Nixon BP, Boulton AJ. Plantar pressure changes using
a novel negative pressure wound therapy technique. J Am Podiatr
Med Assoc 2004 Sep-Oct;94(5):456-60. |
|
|
√ |
Not a NPWT study |
|
| (85) |
Armstrong DG, Lavery LA, Abu-Rumman P, Espensen
EH, Vazquez JR, Nixon BP, Boulton AJ. Outcomes of subatmospheric
pressure dressing therapy on wounds of the diabetic foot.
Ostomy Wound Manage 2002 Apr;48(4):64-8. |
√ |
KQ3 |
|
|
√ |
| (109) |
Armstrong DG, Lavery LA, Boulton AJ. Negative
pressure wound therapy via vacuum-assisted closure following
partial foot amputation: what is the role of wound chronicity?.
Int Wound J 2007 Mar;4(1):79-86. |
√ |
KQ1, KQ3 |
|
|
|
| (195) |
Armstrong DG, Lavery LA, Diabetic Foot Study
Consortium. Negative pressure wound therapy after partial
diabetic foot amputation: a multicentre, randomised controlled
trial. Lancet 2005 Nov 12;366(9498):1704-10. |
|
|
√ |
Study population reported in(109) |
|
| (405) |
Armstrong DG, Lavery LA. Decreasing foot pressures
while implementing topical negative pressure (vacuum-assisted
closure) therapy. Int J Low Extrem Wounds 2004 Mar;3(1):12-5. |
|
|
√ |
Narrative |
|
| (406) |
Attar KH, Imran D, Iyer S. Vacuum-assisted
closure (VAC) therapy in the management of digital pulp defects.
Acta Chir Plast 2007;49(3):75-6. |
|
|
√ |
Case report |
|
| (92) |
Avery C, Pereira J, Moody A, Gargiulo M, Whitworth
I. Negative pressure wound dressing of the radial forearm
donor site. Int J Oral Maxillofac Surg 2000 Jun;29(3):198-200. |
√ |
KQ3 |
|
|
|
| (407) |
Aydin U, Ozgenel Y. A simple solution for
preventing air leakage in VAC therapy for sacral pressure
sores. J Plast Reconstr Aesthet Surg 2008 Oct;61(10):1267-9. |
|
|
√ |
Narrative |
|
| (408) |
Ayello EA, Baranoski S, Morey J. VAC heals
complex wounds. Nurs Spectrum (Phila Tri-State) 2003 Dec;15(24):16-17. |
|
|
√ |
Narrative |
|
| (409) |
Azad SM, Allison K, Khwaja N, Moiemen N. Frostbite
of the gluteal region. Burns 2003 Nov;29(7):739-44. |
|
|
√ |
No abstract available |
|
| (410) |
Baharestani M, de Leon J, Mendez-Eastman S,
Powell G, Weir D, Niezgoda J, Payne W, Nanney LB, Pelham
F, Gupta S. Consensus statement: a practical guide for managing
pressure ulcers with negative pressure wound therapy utilizing
vacuum-assisted closure. Understanding the treatment algorithm.
Adv Skin Wound Care 2008 Jan;21(Suppl 1):1-20. |
|
|
√ |
Guideline |
|
| (411) |
Baharestani MM, Driver VR, de Leon JM, Gabriel
A, Kaplan M, Lantis J, Lavery L, Pelham F, Powell G, Webb
L. Optimizing clinical and cost effectiveness with early
intervention of V.A.C. therapy. Ostomy Wound Manage 2008;54(11
Suppl):1-15. |
|
|
√ |
Narrative |
|
| (199) |
Baharestani MM, Houliston-Otto DB, Barnes
S. Early versus late initiation of negative pressure wound
therapy: examining the impact on home care length of stay.
Ostomy Wound Manage 2008 Nov;54(11):48-53. |
|
|
√ |
No relevant outcomes |
|
| (93) |
Baharestani MM. Negative pressure wound therapy
in the adjunctive management of necrotizing fascitis: examining
clinical outcomes. Ostomy Wound Manage 2008 Apr;54(4):44-50. |
√ |
KQ3 |
|
|
|
| (412) |
Baharestani MM. Negative pressure wound therapy:
an examination of cost-effectiveness. Ostomy Wound Manage
2004 Nov;50(11A Suppl):29S-33S. |
|
|
√ |
Cost analysis |
|
| (162) |
Baharestani MM. Use of negative pressure wound
therapy in the treatment of neonatal and pediatric wounds:
a retrospective examination of clinical outcomes. Ostomy
Wound Manage 2007 Jun;53(6):75-85. |
√ |
KQ3 |
|
|
|
| (413) |
Ballard K, McGregor F. Use of vacuum-assisted
closure therapy following foot amputation. Br J Nurs 2001
Aug;10(15 Suppl):S6-12. |
|
|
√ |
Case report |
|
| (344) |
Bannasch H, Iblher N, Penna V, Torio N, Felmerer
G, Stark GB, Momeni A. A critical evaluation of the concomitant
use of the implantable Doppler probe and the Vacuum Assisted
Closure system in free tissue transfer. Microsurgery 2008;28(6):412-6. |
√ |
KQ3 |
|
|
|
| (414) |
Banwell PE, Ahmed S, Teot L. Topical negative
pressure versus closed surgical wound drainage: a difference
in philosophy. J Wound Care 2005 Oct;14(9):445-7. |
|
|
√ |
Narrative |
|
| (415) |
Banwell PE, Musgrave M. Topical negative pressure
therapy: mechanisms and indications. Int Wound J 2004 Jun;1(2):95-106. |
|
|
√ |
Narrative |
|
| (416) |
Banwell PE, Teot L. Topical negative pressure
(TNP): the evolution of a novel wound therapy. J Wound Care
2003 Jan;12(1):22-8. |
|
|
√ |
Narrative |
|
| (417) |
Banwell PE. Topical negative pressure therapy
in wound care. J Wound Care 1999 Feb;8(2):79-84. |
|
|
√ |
Narrative |
|
| (418) |
Banwell PE. Topical negative pressure therapy:
advances in burn wound management. Ostomy Wound Manage 2004
Nov;50(11A-Suppl):9S-14S. |
|
|
√ |
Narrative |
|
| (153) |
Bapat V, El-Muttardi N, Young C, Venn G, Roxburgh
J. Experience with vacuum-assisted closure of sternal wound
infections following cardiac surgery and evaluation of chronic
complications associated with its use. J Card Surg 2008 May;23(3):227-33. |
√ |
KQ3 |
|
|
|
| (200) |
Barker DE, Kaufman HJ, Smith LA, Ciraulo DL,
Richart CL, Burns RP. Vacuum pack technique of temporary
abdominal closure: a 7-year experience with 112 patients.
J Trauma 2000 Feb;48(2):201-6; discussion 206-7. |
|
|
√ |
Homemade device |
|
| (202) |
Barringer CB, Gorse SJ, Burge TS. The VAC
dressing—a cautionary tale. Br J Plast Surg 2004 Jul;57(5):482. |
|
|
√ |
No abstract available |
|
| (419) |
Baxandall T. Tissue viability. Healing cavity
wounds with negative pressure. Nurs Stand 1996 Oct 30;11(6):49-51. |
|
|
√ |
Narrative |
|
| (420) |
Baynham SA, Kohlman P, Katner HP. Treating
stage IV pressure ulcers with negative pressure therapy:
a case report. Ostomy Wound Manage 1999 Apr;45(4):28-32,
34-5. |
|
|
√ |
Case report |
|
| (421) |
Benbow M, Beldon P, Butcher M, Newton H, Hampton
S, Baxter H. Topical negative pressure: a systemic review
of the available evidence. J Community Nurs 2007 Jun;21(6) |
|
|
√ |
Not relevant - focus on access and usage of
total negative pressure |
|
| (422) |
Benbow M. Update on VAC therapy.Journal of
Community Nursing-Online; 2006 Apr [accessed 2006 Nov 15].
Available: http://www.jcn.com.uk/. |
|
|
√ |
Narrative |
|
| (82) |
Bendewald FP, Cima RR, Metcalf DR, Hassan
I. Using negative pressure wound therapy following surgery
for complex pilonidal disease: a case series. Ostomy Wound
Manage 2007 May;53(5):40-6. |
√ |
KQ3 |
|
|
√ |
| (76) |
Bendo JA, Quirno M, Pelham F, Barone JA, Awad
J. Posterior lumbar wound drainage management with vacuum-assisted
closure. World Spine J 2007 Sep;2(4):187-90. |
√ |
KQ3 |
|
|
√ |
| (423) |
Bennett W. Novel use of VAC therapy in a patient
with lymphocele after varicose surgery. Wounds UK 2007 Dec;3(4):129-32. |
|
|
√ |
Case report |
|
| (424) |
Bernstein BH, Tam H. Combination of subatmospheric
pressure dressing and gravity feed antibiotic instillation
in the treatment of post-surgical diabetic foot wound: a
case series. Wounds 2005 Feb;17(2):37-48. |
|
|
√ |
Narrative |
|
| (425) |
Bertelsen CA, Wille-Jorgensen P. Use of topical
negative pressure to manage a complex wound with a vesicocutaneous
fistula. J Wound Care 2006 Apr;15(4):172-3. |
|
|
√ |
Case report |
|
| (350) |
Bhattacharyya T, Mehta P, Smith M, Pomahac
B. Routine use of wound vacuum-assisted closure does not
allow coverage delay for open tibia fractures. Plast Reconstr
Surg 2008 Apr;121(4):1263-6. |
√ |
KQ3 |
|
|
|
| (134) |
Bickels J, Kollender Y, Wittig JC, Cohen N,
Meller I, Malawer MM. Vacuum-assisted wound closure after
resection of musculoskeletal tumors. Clin Orthop Relat Res
2005 Dec;441:346-50. |
√ |
KQ1, KQ3 |
|
|
|
| (426) |
Birchall L, Street L, Clift H. Developing
a trust-wide centralised approach to the use of TNP. J Wound
Care 2002 Sep;11(8):311-4. |
|
|
√ |
Narrative |
|
| (427) |
Blackburn JH 2d, Boemi L, Hall WW, Jeffords
K, Hauck RM, Banducci DR, Graham WP 3d. Negative-pressure
dressings as a bolster for skin grafts. Ann Plast Surg 1998
May;40(5):453-7. |
|
|
√ |
Narrative |
|
| (108) |
Blume PA, Walters J, Payne W, Ayala J, Lantis
J. Comparison of negative pressure wound therapy using vacuum-assisted
closure with advanced moist wound therapy in the treatment
of diabetic foot ulcers: a multicenter randomized controlled
trial. Diabetes Care 2008 Apr;31(4):631-6. |
√ |
KQ1, KQ3 |
|
|
|
| (141) |
Bollero D, Carnino R, Risso D, Gangemi EN,
Stella M. Acute complex traumas of the lower limbs: A modern
reconstructive approach with negative pressure therapy. Wound
Repair Regen 2007 Jul;15(4):589-94. |
√ |
KQ3 |
|
|
|
| (428) |
Bolton LL. Negative pressure wound therapy.
Wounds 2005 Apr;17(4):A29-A32. |
|
|
√ |
Narrative |
|
| (429) |
Bonnet F, Pavy B, Beaudoin S, Dubousset J,
Mitrofanoff M. Treatment of a large defect of the chest wall
in a child using a negative pressure wound dressing. Scand
J Plast Reconstr Surg Hand Surg 2007;41(3):143-5. |
|
|
√ |
Case report |
|
| (430) |
Bookout K, McCord S, McLane K. Case studies
of an infant, a toddler, and an adolescent treated with a
negative pressure wound treatment system. J Wound Ostomy
Continence Nurs 2004 Jul-Aug;31(4):184-92. |
|
|
√ |
Fewer than five patients |
|
| (207) |
Bovill E, Banwell PE, Teot L, Eriksson E,
Song C, Mahoney J, Gustafsson R, Horch R, Deva A, Whitworth
I, International Advisory Panel on Topical Negative Pressure.
Topical negative pressure wound therapy: a review of its
role and guidelines for its use in the management of acute
wounds. Int Wound J 2008 Oct;5(4):511-29. |
|
|
√ |
Narrative |
|
| (114) |
Braakenburg A, Obdeijn MC, Feitz R, van Rooij
IA, van Griethuysen AJ, Klinkenbijl JH. The clinical efficacy
and cost effectiveness of the vacuum-assisted closure technique
in the management of acute and chronic wounds: a randomized
controlled trial. Plast Reconstr Surg 2006 Aug;118(2):390-7;
discussion 398-400. |
√ |
KQ1, KQ3 |
|
|
|
| (431) |
Brace JA. Negative pressure wound therapy
for abdominal wounds. J Wound Ostomy Continence Nurs 2007
Jul-Aug;34(4):428-30. |
|
|
√ |
Narrative |
|
| (345) |
Brandi C, Grimaldi L, Nisi G, Silvestri A,
Brafa A, Calabro M, D'Aniello C. Treatment with vacuum-assisted
closure and cryo-preserved homologous de-epidermalised dermis
of complex traumas to the lower limbs with loss of substance,
and bones and tendons exposure. J Plast Reconstr Aesthet
Surg 2008 Dec;61(12):1507-11. |
√ |
KQ3 |
|
|
|
| (432) |
Brogna L. Home care management of an ostomy
within a dehisced abdominal wound. J Wound Ostomy Continence
Nurs 2005 May-Jun;32(3):200-2; discussion 202-4. |
|
|
√ |
Case reports |
|
| (433) |
Bronchard R, de Vaumas C, Lasocki S, Jabbour
K, Geffroy A, Kermarrec N, Montravers P. Vacuum-assisted
closure in the treatment of perineal necrotizing skin and
soft tissue infections. Intensive Care Med 2008 Jul;34(7):1345-7. |
|
|
√ |
No abstract available |
|
| (434) |
Bronson N, Menon R, Butler J, Gordon I. Parathyroidectomy,
excision and skin grafting with topical negative pressure
for calciphylactic ulcers. J Wound Care 2007 Jul;16(7):295-7. |
|
|
√ |
Case report |
|
| (435) |
Brown KM, Harper FV, Aston WJ, O'Keefe PA,
Cameron CR. Vacuum-assisted closure in the treatment of a
9-year-old child with severe and multiple dog bite injuries
of the thorax. Ann Thorac Surg 2001 Oct;72(4):1409-10. |
|
|
√ |
Case report |
|
| (436) |
Burton L. Nonhealing foot ulcer. Ostomy Wound
Manage 1999 Sep;45(9):20-1. |
|
|
√ |
Case report |
|
| (144) |
Butter A, Emran M, Al-Jazaeri A, Ouimet A.
Vacuum-assisted closure for wound management in the pediatric
population. J Pediatr Surg 2006 May;41(5):940-2. |
√ |
KQ3 |
|
|
|
| (437) |
Canavese F, Gupta S, Krajbich JI, Emara KM.
Vacuum-assisted closure for deep infection after spinal instrumentation
for scoliosis. J Bone Joint Surg Br 2008 Mar;90(3):377-81. |
√ |
KQ3 |
|
|
|
| (165) |
Caniano DA, Ruth B, Teich S. Wound management
with vacuum-assisted closure: experience in 51 pediatric
patients. J Pediatr Surg 2005 Jan;40(1):128-32; discussion
132. |
√ |
KQ3 |
|
|
|
| (438) |
Canter HI, Isci E, Erk Y. Vacuum-assisted
wound closure for the management of a foot ulcer due to Buerger's
disease. J Plast Reconstr Aesthet Surg 2007 Nov 1;Epub ahead
of print. |
|
|
√ |
Case report |
|
| (439) |
Carson SN, Overall K, Lee-Jahshan S, Travis
E. Vacuum-assisted closure used for healing chronic wounds
and skin grafts in the lower extremities. Ostomy Wound Manage
2004 Mar;50(3):52-8. |
|
|
√ |
Narrative |
|
| (137) |
Catarino PA, Chamberlain MH, Wright NC, Black
E, Campbell K, Robson D, Pillai RG. High-pressure suction
drainage via a polyurethane foam in the management of poststernotomy
mediastinitis. Ann Thorac Surg 2000 Dec;70(6):1891-5. |
|
|
√ |
Not relevant (suction drainage) |
|
| (440) |
Chandawarkar RY, Piorkowski J, Amjad I, Deckers
PJ. Combination therapy of a large, recurrent keloid. Dermatol
Surg 2007 Feb;33(2):229-35. |
|
|
√ |
Case report |
|
| (441) |
Chaouat M, Bonnet F, Seroussi D, Smarrito
S, Mimoun M. Topical negative pressure for the treatment
of complex cavity wounds associated with osteitis. J Wound
Care 2006 Jul;15(7):292-4. |
|
|
√ |
Fewer than five patients |
|
| (442) |
Chariker ME, Jeter KF, Tintle TE, Bottsford
JE. Effective management of incisional and cutaneous fistulae
with close suction wound drainage. Contemp Surg 1989 Jun;34:59-63. |
|
|
√ |
Homemade device |
|
| (443) |
Chave H, Ahmed S, Fu B, Webber J, Banwell
P, Tiernan E. Salvage of infected dermal collagen implants
with topical negative pressure therapy. J Wound Care 2006
Apr;15(4):156-8. |
|
|
√ |
Case report |
|
| (444) |
Chen SZ, Li J, Li XY, Xu LS. Effects of Vacuum-assisted
Closure on Wound Microcirculation: An Experimental Study.
Asian J Surg 2005 Jul;28(3):211-7. |
|
|
√ |
Animal study |
|
| (160) |
Chen Y, Almeida AA, Mitnovetski S, Goldstein
J, Lowe C, Smith JA. Managing deep sternal wound infections
with vacuum-assisted closure. ANZ J Surg 2008 May;78(5):333-6. |
√ |
KQ3 |
|
|
|
| (445) |
Chesher E. Use of vacuum-assisted closure
in the community. Prim Intent 1998 Feb;6(1):12-15. |
|
|
√ |
Case report |
|
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Wound Repair Regen 2004 Nov-Dec;12(6):600-6. |
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Animal study |
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Wada A, Ferreira MC, Tuma Junior P, Arrunategui
G. Experience with local negative pressure (vacuum method)
in the treatment of complex wounds. Sao Paulo Med J 2006
May 4;124(3):150-3. |
√ |
KQ3 |
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| (118) |
Wanner MB, Schwarzl F, Strub B, Zaech GA,
Pierer G. Vacuum‑assisted wound closure for cheaper
and more comfortable healing of pressure sores: a prospective
study. Scand J Plast Reconstr Surg Hand Surg 2003;37(1):28-33. |
√ |
KQ1,KQ3 |
|
|
|
| (172) |
Wasiak J, Cleland H. Topical negative pressure
(TNP) for partial thickness burns. Cochrane Database Syst
Rev 2007;(3):CD006215. |
√ |
Previous Systematic Reviews |
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| (758) |
Webb LX, Lavery D, DeFranzo A. Negative pressure
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Narrative |
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Webb LX, Pape HC. Current thought regarding
the mechanism of action of negative pressure wound therapy
with reticulated open cell foam. J Orthop Trauma 2008 Nov-Dec;22(10
Suppl):S135-7. |
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Webb LX. New techniques in wound management:
vacuum-assisted wound closure. J Am Acad Orthop Surg 2002
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√ |
Narrative |
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| (37) |
Weed T, Ratliff C, Drake DB. Quantifying bacterial
bioburden during negative pressure wound therapy: does the
wound VAC enhance bacterial clearance. Ann Plast Surg 2004
Mar;52(3):276-9; discussion 279-80. |
√ |
KQ3 |
|
|
|
| (761) |
Weinfeld AB, Kelley P, Yuksel E, Tiwari P,
Hsu P, Choo J, Hollier LH. Circumferential negative-pressure
dressing (VAC) to bolster skin grafts in the reconstruction
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|
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√ |
Case reports |
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| (762) |
Wessel LC, Cunningham BL. Patient with compartment
syndrome of the lower extremity. J Wound Ostomy Continence
Nurs 2002 Jul;29(4):210-5. |
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√ |
Case report |
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| (763) |
Whelan C, Stewart J, Schwartz BF. Mechanics
of wound healing and importance of Vacuum Assisted Closure
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√ |
Narrative |
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| (764) |
White RA, Miki RA, Kazmier P, Anglen JO. Vacuum-assisted
closure complicated by erosion and hemorrhage of the anterior
tibial artery. J Orthop Trauma 2005 Jan;19(1):56-9. |
|
|
√ |
Case report |
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| (765) |
Whitney J, Phillips L, Aslam R, Barbul A,
Gottrup F, Gould L, Robson MC, Rodeheaver G, Thomas D, Stotts
N. Guidelines for the treatment of pressure ulcers. Wound
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|
|
√ |
Guideline |
|
| (116) |
Wild T, Stremitzer S, Budzanowski A, Hoelzenbein
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therapy—A randomised controlled trial comparing Redon
drains with V.A.C. Therapy™. Int Wound J 2008 Dec;5(5):641-7. |
√ |
KQ2 |
|
|
|
| (766) |
Wilkes R, Zhao Y, Kieswetter K, Haridas B.
Effects of Dressing Type on 3D Tissue Microdeformations During
Negative Pressure Wound Therapy: A Computational Study. J
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|
|
√ |
Not a clinical study |
|
| (767) |
Willy C, Voelker HU, Engelhardt M. Literature
on the subject of vacuum therapy: review and update 2006.
Eur J Trauma Emerg Surg 2007 Feb;33(1):33-9. |
|
|
√ |
Not relevant - not a systematic review of
wound healing data |
|
| (768) |
Wiseman J, Cullington JR, Schaeferle M 3rd,
Beckham PH, Salisbury M, Ersek RA. Aesthetic aspects of neurofibromatosis
reconstruction with the vacuum-assisted closure system. Aesthetic
Plast Surg 2001 Sep-Oct;25(5):326-31. |
|
|
√ |
Case Report |
|
| (769) |
Wolvos T. Wound instillation with negative
pressure wound therapy. Ostomy Wound Manage 2005 Feb;51(2A
Suppl):21S-6S. |
|
|
√ |
Narrative |
|
| (770) |
Wolvos T. Wound instillation--the next step
in negative pressure wound therapy. Lessons learned from
initial experiences. Ostomy Wound Manage 2004 Nov;50(11):56-66. |
|
|
√ |
Narrative |
|
| (161) |
Wondberg D, Larusson HJ, Metzger U, Platz
A, Zingg U. Treatment of the open abdomen with the commercially
available vacuum-assisted closure system in patients with
abdominal sepsis: low primary closure rate. World J Surg
2008 Dec;32(12):2724-9. |
√ |
KQ3 |
|
|
|
| (771) |
Wong LK, Nesbit RD, Turner LA, Sargent LA.
Management of a circumferential lower extremity degloving
injury with the use of vacuum-assisted closure. South Med
J 2006 Jun;99(6):628-30. |
|
|
√ |
Case Report |
|
| (75) |
Wongworawat MD, Schnall SB, Holtom PD, Moon
C, Schiller F. Negative pressure dressings as an alternative
technique for the treatment of infected wounds. Clin Orthop
Relat Res 2003 Sep;(414):45-8. |
√ |
KQ3 |
|
|
√ |
| (772) |
Woo KY, Sibbald RG. Vacuum-assisted closure
home care training: a process to link education to improved
patient outcomes. Int Wound J 2008 Jun;5 Suppl 2:1-9. |
|
|
√ |
Narrative |
|
| (773) |
Wound wonder. Middle East Medical 2003 May-Jun;61-5. |
|
|
√ |
Narrative |
|
| (774) |
Wu S. Case study: treating a patient with
a diabetic neuropathic ulceration. APMA News 2005 May;26(5-Suppl):19. |
|
|
√ |
Case Report |
|
| (775) |
Wu SC, Lavery LA, Armstrong DG. Closing difficult
wounds. Podiatry Today 2006 Mar;19(3):44-54. |
|
|
√ |
Narrative |
|
| (776) |
Wu Sc, Yoon H, Armstrong DG. Therapy with
advanced modalities: can it expedite healing?. Podiatry Today
2005 Sep;18(9):18-24. |
|
|
√ |
Narrative |
|
| (158) |
Wu SH, Zecha PJ, Feitz R, Hovius SE. Vacuum
therapy as an intermediate phase in wound closure: A clinical
experience. Eur J Plastic Surg 2000 May;23(4):174-7. |
√ |
KQ3 |
|
|
|
| (777) |
Wustmann O, Ulrich HC. German patent specification.
Appliance for the drainage of wounds. No. 847 475 Class 30
K Group 17 04. 1952 |
|
|
√ |
Not relevant |
|
| (72) |
Yang CC, Chang DS, Webb LX. Vacuum-assisted
closure for fasciotomy wounds following compartment syndrome
of the leg. J Surg Orthop Adv 2006 Spring;15(1):19-23. |
√ |
KQ1 |
|
|
√ |
| (778) |
Yoong S, Dunne G, Cochrane J, Lee B, Lee J.
Vacuum-assisted closure for the treatment of parastomal skin
necrosis: a novel approach to an unusual complication. Report
of a case. Dis Colon Rectum 2008 Oct;51(10):1577-9. |
|
|
√ |
Case report |
|
| (779) |
Yousaf M, Witherow A, Gardiner KR, Gilliland
R. Use of vacuum-assisted closure for healing of a persistent
perineal sinus following panproctocolectomy: report of a
case. Dis Colon Rectum 2004 Aug;47(8):1403-7; discussion
1407-8. |
|
|
√ |
Case report |
|
| (780) |
Yuan-Innes MJ, Temple CL, Lacey MS. Vacuum-assisted
wound closure: a new approach to spinal wounds with exposed
hardware. Spine 2001 Feb 1;26(3):E30-3. |
|
|
√ |
Fewer than five patients |
|
| (781) |
Yuh DD, Albaugh M, Ullrich S, Conte JV. Treatment
of ventricular assist device driveline infection with vacuum-assisted
closure system. Ann Thorac Surg 2005 Oct;80(4):1493-5. |
|
|
√ |
Case report |
|
| (782) |
Zamierowski D. United States Patent. Wound
dressing and treatment method. No. 4969880. 1990. |
|
|
√ |
Patent |
|
| (783) |
Zehnder SW, Place HM. Vacuum-assisted wound
closure in postoperative spinal wound infection. Orthopedics
2007 Apr;30(4):267-72. |
|
|
√ |
Narrative |
|
| (784) |
Zutt M, Haas E, Kruger U, Distler M, Neumann
C. Successful use of vacuum-assisted closure therapy for
leg ulcers caused by occluding vasculopathy and inflammatory
vascular diseases—a case series. Dermatology 2007;214(4):319-24. |
|
|
√ |
Case reports |
|
KQ Key question
Return to Top
Figure 7 . Disposition of Submission by Kinetic Concepts,
Inc.
![Select [D] below for full text description of this figure.](npwtdfig7.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Return to Top
Table 44. Status of Submissions
by Kinetic Concepts, Inc.
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not Identified
in ECRI Search |
| (390) |
Abai B, Zickler RW, Pappas PJ, Lal BK, Padberg FT Jr. Lymphorrhea
responds to negative pressure wound therapy. J Vasc Surg
2007 Mar;45(3):610-3. |
|
|
√ |
Fewer than five patients |
|
| (152) |
Adamkova M, Tymonova J, Zamecnikova I, Kadlcik M, Klosova
H. First experience with the use of vacuum assisted closure
in the treatment of skin defects at the Burn Center. Acta
Chir Plast 2005;47(1):24-7. |
√ |
KQ3 |
|
|
|
| (372) |
Agarwal JP, Ogilvie M, Wu LC, Lohman RF, Gottlieb LJ, Franczyk
M, Song DH. Vacuum-assisted closure for sternal wounds: A
first-line therapeutic management approach. Plast Reconstr
Surg 2005 Sep 15;116(4):1035-40. |
√ |
KQ3 |
|
|
|
| (391) |
Agrawal S, Hayhurst C, Joseph T, Prinsloo D, Morgan RH,
Pherwani AD. Successful salvage of infected and exposed non-absorbable
mesh following decompressing laparostomy after emergency
repair of ruptured abdominal aortic aneurysm using vacuum-assisted
closure system. Eur J Vasc Endovasc Surg 2008 Jan;15(1):1-2. |
|
|
√ |
Narrative |
|
| (392) |
Aguinaga S, Welber A, Stephens S. Positive steps towards
negative pressure wound therapy. Medsurg Nurs 2007 Jun;16(3):181-2,
189. |
|
|
√ |
Narrative |
|
| (393) |
Alvarez AA, Maxwell GL, Rodriguez GC. Vacuum-assisted closure
for cutaneous gastrointestinal fistula management. Gynecol
Oncol 2001 Mar;80(3):413-6. |
|
|
√ |
Case report |
|
| (394) |
Andrabi SI, Ahmad J, Rathore MA, Yousaf M. Vacuum assisted
closure of laparostomy wounds "a novel technique".
J Ayub Med Coll Abbottabad 2007 Jul-Sep;19(3):89-92. |
|
|
√ |
Case report |
|
| (395) |
Andrabi SI, Ahmad J. Negative pressure therapy for laparotomy
wounds—a word of caution. J Wound Ostomy Continence
Nurs 2007 Jul-Aug;34(4):425-7. |
|
|
√ |
Case report |
|
| (396) |
Andrews BT, Smith RB, Chang KE, Scharpf J, Goldstein DP,
Funk GF. Management of the radial forearm free flap donor
site with the vacuum-assisted closure (VAC) system. Laryngoscope
2006 Oct;116(10):1918-22. |
|
|
√ |
No relevant outcomes |
|
| (88) |
Andrews BT, Smith RB, Goldstein DP, Funk GF. Management
of complicated head and neck wounds with vacuum-assisted
closure system. Head Neck 2006 Nov;28(11):974-81. |
√ |
KQ3 |
|
|
√ |
| (397) |
Andrews BT, Smith RB, Hoffman HT, Funk GF. Orocutaneous
and pharyngocutaneous fistula closure using a vacuum-assisted
closure system. Ann Otol Rhinol Laryngol 2008 Apr;117(4):298-302. |
|
|
√ |
Fewer than five patients |
|
| (398) |
Andros G, Armstrong DG, Attinger C, Boutlon AJ, Frykberg
RG, Joseph WS, Lavery LA, Morbach S, Niezgoda JA, Toursarkissian
B. Consensus statement on negative pressure wound therapy
(VAC Therapy) for the management of diabetic foot wounds.
Wounds 2006 Jun;52(6 Suppl):1-32. |
|
|
√ |
Guideline |
|
| (385) |
Antony S, Terrazas S. A retrospective study: Clinical experience
using vacuum-assisted closure in the treatment of wounds.
J Natl Med Assoc 2004;96(8):1073-7. |
√ |
KQ3 |
|
|
|
| (192) |
Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource
utilization and economic costs of care based on a randomized
trial of vacuum-assisted closure therapy in the treatment
of diabetic foot wounds. Am J Surg 2008 Jun;195(6):782-8. |
|
|
√ |
Cost analysis |
|
| (399) |
Arca MJ, Somers KK, Derks TE, Goldin AB, Aiken JJ, Sato
TT, Shilyansky J, Winthrop A, Oldham KT. Use of vacuum-assisted
closure system in the management of complex wounds in the
neonate. Pediatr Surg Int 2005 Jul;21(7):532-5. Epub 2005
Jun 17. |
|
|
√ |
Fewer than five patients |
|
| (400) |
Archdeacon MT, Messerschmitt P. Modern papineau technique
with vacuum-assisted closure. J Orthop Trauma 2006 Feb;20(2):134-7. |
|
|
√ |
Case report |
|
| (401) |
Argenta LC, Morykwas MJ, Marks MW, DeFranzo AJ, Molnar
JA, David LR. Vacuum-assisted closure: state of clinic art.
Plast Reconstr Surg 2006 Jun;117(7 Suppl):127S-142S. |
|
|
√ |
Narrative |
|
| (148) |
Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new
method for wound control and treatment: clinical experience.
Ann Plast Surg 1997 Jun;38(6):563-76; discussion 577. |
√ |
KQ3 |
|
|
√ |
| (402) |
Argenta PA, Rahaman J, Gretz HF 3rd, Nezhat F, Cohen CJ.
Vacuum-assisted closure in the treatment of complex gynecologic
wound failures. Obstet Gynecol 2002 Mar;99(3):497-501. |
|
|
√ |
Fewer than five patients |
|
| (785) |
Argenta A, Webb K, Simpson J, Gordon S, Kortesis B, Wanner
M, Kremers L, Morykwas M. Deformation of superficial and
deep abdominal tissues with application of a controlled vacuum.
In: European Tissue Repair Society, Focus group meeting Topical
Negative Pressure (TNP) Therapy; 4-6 December 2003; London. |
|
|
√ |
Focus on cellular and biochemistry measurements |
|
| (403) |
Armstrong DG, Attinger CE, Boulton AJ, Frykberg RG, Kirsner
RS, Lavery LA, Mills JL. Guidelines regarding negative wound
therapy (NPWT) in the diabetic foot. Ostomy Wound Manage
2004 Apr;50(4B Suppl):3S-27S. |
|
|
√ |
Guideline |
|
| (404) |
Armstrong DG, Boulton AJ, Banwell P. Negative pressure
wound therapy in treatment of diabetic foot wounds: a marriage
of modalities. Ostomy Wound Manage 2004 Apr;50(4A Suppl):9-12. |
|
|
√ |
Narrative |
|
| (194) |
Armstrong DG, Kunze K, Martin BR, Kimbriel HR, Nixon BP,
Boulton AJ. Plantar pressure changes using a novel negative
pressure wound therapy technique. J Am Podiatr Med Assoc
2004 Sep-Oct;94(5):456-60. |
|
|
√ |
Homemade device |
|
| (85) |
Armstrong DG, Lavery LA, Abu-Rumman P, Espensen EH, Vazquez
JR, Nixon BP, Boulton AJ. Outcomes of subatmospheric pressure
dressing therapy on wounds of the diabetic foot. Ostomy Wound
Manage 2002 Apr;48(4):64-8. |
√ |
KQ3 |
|
|
√ |
| (109) |
Armstrong DG, Lavery LA, Boulton AJ. Negative pressure
wound therapy via vacuum-assisted closure following partial
foot amputation: what is the role of wound chronicity?. Int
Wound J 2007 Mar;4(1):79-86. |
√ |
KQ1, KQ3 |
|
|
|
| (195) |
Armstrong DG, Lavery LA, Diabetic Foot Study Consortium.
Negative pressure wound therapy after partial diabetic foot
amputation: a multicentre, randomised controlled trial. Lancet
2005 Nov 12;366(9498):1704-10. |
|
|
√ |
Study population reported in (80) |
|
| (405) |
Armstrong DG, Lavery LA. Decreasing foot pressures while
implementing topical negative pressure (vacuum-assisted closure)
therapy. Int J Low Extrem Wounds 2004 Mar;3(1):12-5. |
|
|
√ |
Narrative |
|
| (406) |
Attar KH, Imran D, Iyer S. Vacuum-assisted closure (VAC)
therapy in the management of digital pulp defects. Acta Chir
Plast 2007;49(3):75-6. |
|
|
√ |
Case report |
|
| (92) |
Avery C, Pereira J, Moody A, Gargiulo M, Whitworth I. Negative
pressure wound dressing of the radial forearm donor site.
Int J Oral Maxillofac Surg 2000 Jun;29(3):198-200. |
√ |
To be included in KQ3 |
|
|
|
| (407) |
Aydin U, Ozgenel Y. A simple solution for preventing air
leakage in VAC therapy for sacral pressure sores. J Plast
Reconstr Aesthet Surg 2008 Oct;61(10):1267-9. |
|
|
√ |
Narrative |
|
| (408) |
Ayello EA, Baranoski S, Morey J. VAC heals complex wounds.
Nurs Spectrum (Phila Tri-State) 2003 Dec;15(24):16-17. |
|
|
√ |
Narrative |
|
| (409) |
Azad SM, Allison K, Khwaja N, Moiemen N. Frostbite of the
gluteal region. Burns 2003 Nov;29(7):739-44. |
|
|
√ |
No abstract available |
|
| (410) |
Baharestani M, de Leon J, Mendez-Eastman S, Powell G, Weir
D, Niezgoda J, Payne W, Nanney LB, Pelham F, Gupta S. Consensus
statement: a practical guide for managing pressure ulcers
with negative pressure wound therapy utilizing vacuum-assisted
closure. Understanding the treatment algorithm. Adv Skin
Wound Care 2008 Jan;21(Suppl 1):1-20. |
|
|
√ |
Guideline |
|
| (411) |
Baharestani MM, Driver VR, de Leon JM, Gabriel A, Kaplan
M, Lantis J, Lavery L, Pelham F, Powell G, Webb L. Optimizing
clinical and cost effectiveness with early intervention of
V.A.C. therapy. Ostomy Wound Manage 2008;54(11 Suppl):1-15. |
|
|
√ |
Narrative |
|
| (199) |
Baharestani MM, Houliston-Otto DB, Barnes S. Early versus
late initiation of negative pressure wound therapy: examining
the impact on home care length of stay. Ostomy Wound Manage
2008 Nov;54(11):48-53. |
|
|
√ |
No relevant outcomes |
|
| (93) |
Baharestani MM. Negative pressure wound therapy in the
adjunctive management of necrotizing fascitis: examining
clinical outcomes. Ostomy Wound Manage 2008 Apr;54(4):44-50. |
√ |
To be included in KQ3 |
|
|
|
| (412) |
Baharestani MM. Negative pressure wound therapy: an examination
of cost-effectiveness. Ostomy Wound Manage 2004 Nov;50(11A
Suppl):29S-33S. |
|
|
√ |
Cost analysis |
|
| (162) |
Baharestani MM. Use of negative pressure wound therapy
in the treatment of neonatal and pediatric wounds: a retrospective
examination of clinical outcomes. Ostomy Wound Manage 2007
Jun;53(6):75-85. |
√ |
KQ3 |
|
|
|
| (413) |
Ballard K, McGregor F. Use of vacuum-assisted closure therapy
following foot amputation. Br J Nurs 2001 Aug;10(15 Suppl):S6-12. |
|
|
√ |
Case report |
|
| (344) |
Bannasch H, Iblher N, Penna V, Torio N, Felmerer G, Stark
GB, Momeni A. A critical evaluation of the concomitant use
of the implantable Doppler probe and the Vacuum Assisted
Closure system in free tissue transfer. Microsurgery 2008;28(6):412-6. |
√ |
KQ3 |
|
|
|
| (414) |
Banwell PE, Ahmed S, Teot L. Topical negative pressure
versus closed surgical wound drainage: a difference in philosophy.
J Wound Care 2005 Oct;14(9):445-7. |
|
|
√ |
Narrative |
|
| (415) |
Banwell PE, Musgrave M. Topical negative pressure therapy:
mechanisms and indications. Int Wound J 2004 Jun;1(2):95-106. |
|
|
√ |
Narrative |
|
| (416) |
Banwell PE, Teot L. Topical negative pressure (TNP): the
evolution of a novel wound therapy. J Wound Care 2003 Jan;12(1):22-8. |
|
|
√ |
Narrative |
|
| (417) |
Banwell PE. Topical negative pressure therapy in wound
care. J Wound Care 1999 Feb;8(2):79-84. |
|
|
√ |
Narrative |
|
| (418) |
Banwell PE. Topical negative pressure therapy: advances
in burn wound management. Ostomy Wound Manage 2004 Nov;50(11A-Suppl):9S-14S. |
|
|
√ |
Narrative |
|
| (153) |
Bapat V, El-Muttardi N, Young C, Venn G, Roxburgh J. Experience
with vacuum-assisted closure of sternal wound infections
following cardiac surgery and evaluation of chronic complications
associated with its use. J Card Surg 2008 May;23(3):227-33. |
√ |
KQ3 |
|
|
|
| (200) |
Barker DE, Kaufman HJ, Smith LA, Ciraulo DL, Richart CL,
Burns ;RP. Vacuum pack technique of temporary abdominal closure:
a 7-year experience with 112 patients. J Trauma 2000 Feb;48(2):201-6;
discussion 206-7. |
|
|
√ |
Homemade device |
|
| (202) |
Barringer CB, Gorse SJ, Burge TS. The VAC dressing—a
cautionary tale. Br J Plast Surg 2004 Jul;57(5):482. |
|
|
√ |
No abstract available |
|
| (419) |
Baxandall T. Tissue viability. Healing cavity wounds with
negative pressure. Nurs Stand 1996 Oct 30;11(6):49-51. |
|
|
√ |
Narrative |
|
| (420) |
Baynham SA, Kohlman P, Katner HP. Treating stage IV pressure
ulcers with negative pressure therapy: a case report. Ostomy
Wound Manage 1999 Apr;45(4):28-32, 34-5. |
|
|
√ |
Case report |
|
| (421) |
Benbow M, Beldon P, Butcher M, Newton H, Hampton S, Baxter
H. Topical negative pressure: a systemic review of the available
evidence. J Community Nurs 2007 Jun;21(6) |
|
|
√ |
Not relevant - focus on access and usage of total negative
pressure |
|
| (422) |
Benbow M. Update on VAC therapy.Journal of Community Nursing-Online;
2006 Apr [accessed 2006 Nov 15]. Available: http://www.jcn.com.uk/. |
|
|
√ |
Narrative |
|
| (82) |
Bendewald FP, Cima RR, Metcalf DR, Hassan I. Using negative
pressure wound therapy following surgery for complex pilonidal
disease: a case series. Ostomy Wound Manage 2007 May;53(5):40-6. |
√ |
KQ3 |
|
|
√ |
| (76) |
Bendo JA, Quirno M, Pelham F, Barone JA, Awad J. Posterior
lumbar wound drainage management with vacuum-assisted closure.
World Spine J 2007 Sep;2(4):187-90. |
√ |
KQ3 |
|
|
√ |
| (423) |
Bennett W. Novel use of VAC therapy in a patient with lymphocele
after varicose surgery. Wounds UK 2007 Dec;3(4):129-32. |
|
|
√ |
Case report |
|
| (424) |
Bernstein BH, Tam H. Combination of subatmospheric pressure
dressing and gravity feed antibiotic instillation in the
treatment of post-surgical diabetic foot wound: a case series.
Wounds 2005 Feb;17(2):37-48. |
|
|
√ |
Narrative |
|
| (425) |
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Labler L, Keel M, Trentz O, Heinzelmann M. Wound conditioning
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Lavery L. Disease management programs: can they make a
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Liao EC, Breuing KH. Breast mound salvage using vacuum-assisted
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López Almodóvar LF, Bustos G, Lima P, Canas
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Early Fascial Closure of Open Abdomens after Severe Trauma.
J Trauma Inj Infect Crit Care 2003;55(6):1155-60. |
√ |
KQ3 |
|
|
|
| (732) |
Summaries of current clinical evidence Engenex NPWT system.
Skillman (NJ): ConvaTec, Inc.; 2 p. |
|
|
√ |
Poster presentation |
|
| (733) |
Sunog T. Closing time. Adv Nurs 2003 Aug;18(34):39. |
|
|
√ |
No abstract available |
|
| (734) |
Svedman, et al. A dressing system providing fluid supply
and suction drainage used for continuous or intermittent
irrigation. Ann Plast Surg 1986 Aug;17(2):125-33. |
|
|
√ |
Narrative |
|
| (149) |
Svensson S, Monsen C, Kolbel T, Acosta S. Predictors for
Outcome after Vacuum Assisted Closure Therapy of Peri-vascular
Surgical Site Infections in the Groin. Eur J Vasc Endovasc
Surg 2008 Jul;36(1):84-9. |
√ |
KQ3 |
|
|
|
| (735) |
Tan D, Rajanayagam J, Schwarz F. Treatment of long-standing,
poor-healing diabetic foot ulcers with topical negative pressure
in the Torres Strait. Aust J Rural Health 2007 Aug;15(4):275-6. |
|
|
√ |
Case report |
|
| (736) |
Tang AT, Ohri SK, Haw MP. Novel application of vacuum assisted
closure technique to the treatment of sternotomy wound infection.
Eur J Cardiothorac Surg 2000 Apr;17(4):482-4. |
|
|
√ |
Narrative |
|
| (737) |
Tang AT, Okri SK, Haw MP. Vacuum-assisted closure to treat
deep sternal wound infection following cardiac surgery. J
Wound Care 2000 May;9(5):229-30. |
|
|
√ |
Case report |
|
| (323) |
Tanna N, Clary MS, Conrad DE, Lenert J, Sadeghi N. Vacuum-assisted
closure for wound dehiscence in head and neck reconstruction.
Plast Reconstr Surg 2009 Jan;123(1):19e-21e. |
|
|
√ |
Case report |
|
| (738) |
Tarkin IS. The versatility of negative pressure wound therapy
with reticulated open cell foam for soft tissue management
after severe musculoskeletal trauma. J Orthop Trauma 2008
Nov-Dec;22(10 Suppl):S146-51. |
|
|
√ |
Narrative |
|
| (739) |
Taub PJ, Schulman MR, Sett S, Koch RM. Revisiting vascularized
muscle flaps for complicated sternal wounds in children.
Ann Plast Surg 2005 Nov;55(5):535-7. |
|
|
√ |
Case report |
|
| (229) |
Teot L, Lambert L, Ourabah Z, Bey E, Steenman C, Wierzbiecka
E, Malikov S, Charles JP, Vives F, Bohbot S. Use of topical
negative pressure with a lipidocolloid dressing: results
of a clinical evaluation. J Wound Care 2006 Sep;15(8):355-8. |
|
|
√ |
Homemade device |
|
| (740) |
Terrazas SG. Adjuvant dressing for negative pressure wound
therapy in burns. Ostomy Wound Manage 2006 Jan;52(1):16,
18. |
|
|
√ |
No abstract available |
|
| (741) |
Thomas S. An introduction to the use of vacuum assisted
closure. In: World Wide Wounds [serial online]. ; 2001 May
[accessed 2001 Jun 11]. [25 screens]. Available: http://www.worldwidewounds.com/2001/may/Thomas/Vacuum-Assisted-Closure.htm |
|
|
√ |
Narrative |
|
| (742) |
Thomas T. (Executive Director, Association for the Advancement
of Wound Care. Malvern, PA). Personal communication— Full
submission packet. 2009 Feb 1. 142 p p. |
|
|
√ |
Personal communication |
|
| (743) |
Thompson JT, Marks MW. Negative pressure wound therapy.
Clin Plast Surg 2007 Oct;34(4):673-84. |
|
|
√ |
Narrative |
|
| (326) |
Timmers MS, Le Cessie S, Banwell P, Jukema GN. The effects
of varying degrees of pressure delivered by negative-pressure
wound therapy on skin perfusion. Ann Plast Surg 2005 Dec;55(6):665-71. |
|
|
√ |
No relevant outcomes |
|
| (744) |
Torbrand C, Ingemansson R, Gustafsson L, Paulsson P, Malmsjo
M. Pressure transduction to the thoracic cavity during topical
negative pressure therapy of a sternotomy wound. Int Wound
J 2008 Oct;5(4):579-84. |
|
|
√ |
Animal study |
|
| (745) |
Torbrand C, Wackenfors A, Lindstedt S, Ekman R, Ingemansson
R, Malmsjo M. Sympathetic and sensory nerve activation during
negative pressure therapy of sternotomy wounds. Interact
Cardiovasc Thorac Surg 2008 Dec;7(6):1067-70. |
|
|
√ |
Animal study |
|
| (746) |
Trop M, Schintler M, Urban E, Roedl S, Stockenhuber A.
Are 1:4 mesh and donor site contraindications for vacuum-assisted
closure device. J Trauma 2006 Nov;61(5):1267-70. |
|
|
√ |
No abstract available |
|
| (747) |
Trueman P, Flack S, Loonstra A, Hauser T. The feasibility
of using V.A.C. Therapy in home care patients with surgical
and traumatic wounds in the Netherlands. Int Wound J 2008
Jun;5(2):225-31. |
|
|
√ |
Not a clinical study |
|
| (748) |
Trueman P. Cost-effectiveness considerations for home health
V.A.C. Therapy in the United States of America and its potential
international application. Int Wound J 2008 Jun;5 Suppl 2:23-6. |
|
|
√ |
Cost effectiveness |
|
| (174) |
Ubbink DT, Westerbos SJ, Evans D, Land L, Vermeulen H.
Topical negative pressure for treating chronic wounds (Review).
In: Cochrane Database of Systematic Reviews [internet]. Issue
3. Hoboken (NJ): John Wiley & Sons, Ltd.; 2008 [Art.
No.: CD001898]. |
√ |
Previous Systematic Reviews |
|
|
|
| (183) |
Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen H. A systematic
review of topical negative pressure therapy for acute and
chronic wounds. Br J Surg 2008 Jun;95(6):685-92. |
√ |
Previous Systematic Reviews |
|
|
|
| (228) |
Using topical negative pressure with a lipidocolloid dressing.
Ostomy Wound Manage 2008 Jun;54(6):12-4. |
|
|
√ |
No abstract available |
|
| (749) |
Uygur F, Duman H, Ulkur E, Ceikoz B. The role of the vacuum-assisted
closure therapy in the salvage of venous congestion of the
free flap: case report. Int Wound J 2008 Mar;5(1):50-3. |
|
|
√ |
Case report |
|
| (750) |
Vallet C, Saucy F, Haller C, Meier P, Rafoul W, Corpataux
JM. Vacuum-assisted conservative treatment for the management
and salvage of exposed prosthetic hemodialysis access. Eur
J Vasc Endovasc Surg 2004 Oct;28(4):397-9. |
|
|
√ |
Case reports |
|
| (107) |
van den Boogaard M, de Laat E, Spauwen P, Schoonhoven L.
The effectiveness of topical negative pressure in the treatment
of pressure ulcers: a literature review. Eur J Plastic Surg
2008 Apr;31(1):1-7. |
√ |
KQ1, KQ3 |
|
|
|
| (368) |
van Rhee MA, de Klerk LW, Verhaar JA. Vacuum-assisted wound
closure of deep infections after instrumented spinal fusion
in six children with neuromuscular scoliosis. Spine J 2007
Sep-Oct;7(5):596-600. |
√ |
KQ3 |
|
|
|
| (751) |
Varker KA, Ng T. Management of empyema cavity with the
vacuum-assisted closure device. Ann Thorac Surg 2006 Feb;81(2):723-5. |
|
|
√ |
Case report |
|
| (752) |
Venturi ML, Attinger CE, Mesbahi AN, Hess CL, Graw KS.
Mechanisms and clinical applications of the vacuum-assisted
closure (VAC) Device: a review. Am J Clin Dermatol 2005;6(3):185-94. |
|
|
√ |
Narrative |
|
| (753) |
Verhaalen Al. Isolation of an entercutaneous fistula within
a vacuum-assisted wound closure system. Gen Surg 2006 Aug;33(8) |
|
|
√ |
Case report |
|
| (754) |
Verrillo SC. Negative pressure therapy for infected sternal
wounds: a literature review. J Wound Ostomy Continence Nurs
2004 Mar-Apr;31(2):72-4. |
|
|
√ |
Narrative |
|
| (342) |
Vidrine DM, Kaler S, Rosenthal EL. A comparison of negative-pressure
dressings versus Bolster and splinting of the radial forearm
donor site. Otolaryngol Head Neck Surg 2005 Sep;133(3):403-6. |
√ |
KQ1, KQ3 |
|
|
|
| (178) |
Vikatmaa P, Juutilainen V, Kuukasjarvi P, Malmivaara A.
Negative Pressure Wound Therapy: a Systematic Review on Effectiveness
and Safety. Eur J Vasc Endovasc Surg 2008 Oct;36(4):438-48. |
√ |
Previous Systematic Reviews |
|
|
|
| (755) |
von Gossler CM, Horch RE. Rapid aggressive soft-tissue
necrosis after beetle bite can be treated by radical necrectomy
and vacuum suction-assisted closure. J Cutan Med Surg 2000
Oct;4(4):219-22. |
|
|
√ |
Case report |
|
| (115) |
Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH,
Veraart JC. State-of-the-art treatment of chronic leg ulcers:
A randomized controlled trial comparing vacuum-assisted closure
(V.A.C.) with modern wound dressings. J Vasc Surg 2006 Nov;44(5):1029-37;
discussion 1038. |
√ |
KQ1, KQ3 |
|
|
|
| (756) |
Wackenfors A, Gustafsson R, Sjogren J, Algotsson L, Ingemansson
R, Malmsjo M. Blood flow responses in the peristernal thoracic
wall during vacuum-assisted closure therapy. Ann Thorac Surg
2005 May;79(5):1724-30; discussion 1730-. |
|
|
√ |
Animal study |
|
| (757) |
Wackenfors A, Sjogren J, Algotsson L, Gustafsson R, Ingemansson
R, Malmsjo M. The effect of vacuum-assisted closure therapy
on the pig femoral artery vasomotor responses. Wound Repair
Regen 2004 Mar-Apr;12(2):244- |
|
|
√ |
Animal study |
|
| (40) |
Wackenfors A, Sjogren J, Gustafsson R, Algotsson L, Ingemansson
R, Malmsjo M. Effects of vacuum-assisted closure therapy
on inguinal wound edge microvascular blood flow. Wound Repair
Regen 2004 Nov-Dec;12(6):600-6. |
|
|
√ |
Animal study |
|
| (384) |
Wada A, Ferreira MC, Tuma Junior P, Arrunategui G. Experience
with local negative pressure (vacuum method) in the treatment
of complex wounds. Sao Paulo Med J 2006 May 4;124(3):150-3. |
√ |
KQ3 |
|
|
|
| (118) |
Wanner MB, Schwarzl F, Strub B, Zaech GA, Pierer G. Vacuum-assisted
wound closure for cheaper and more comfortable healing of
pressure sores: a prospective study. Scand J Plast Reconstr
Surg Hand Surg 2003;37(1):28-33. |
√ |
KQ1,KQ3 |
|
|
|
| (172) |
Wasiak J, Cleland H. Topical negative pressure (TNP) for
partial thickness burns. Cochrane Database Syst Rev 2007;(3):CD006215. |
√ |
Previous Systematic Review |
|
|
|
| (758) |
Webb LX, Lavery D, DeFranzo A. Negative pressure wound
therapy in the management of orthopedic wounds. Ostomy Wound
Manage 2004 Apr;50(4A Suppl):26-7. |
|
|
√ |
Narrative |
|
| (759) |
Webb LX, Pape HC. Current thought regarding the mechanism
of action of negative pressure wound therapy with reticulated
open cell foam. J Orthop Trauma 2008 Nov-Dec;22(10 Suppl):S135-7. |
|
|
√ |
Narrative |
|
| (760) |
Webb LX. New techniques in wound management: vacuum-assisted
wound closure. J Am Acad Orthop Surg 2002 Sep-Oct;10(5):303-11. |
|
|
√ |
Narrative |
|
| (37) |
Weed T, Ratliff C, Drake DB. Quantifying bacterial bioburden
during negative pressure wound therapy: does the wound VAC
enhance bacterial clearance. Ann Plast Surg 2004 Mar;52(3):276-9;
discussion 279-80. |
√ |
KQ3 |
|
|
|
| (761) |
Weinfeld AB, Kelley P, Yuksel E, Tiwari P, Hsu P, Choo
J, Hollier LH. Circumferential negative-pressure dressing
(VAC) to bolster skin grafts in the reconstruction of the
penile shaft and scrotum. Ann Plast Surg 2005 Feb;54(2):178-83. |
|
|
√ |
Case reports |
|
| (762) |
Wessel LC, Cunningham BL. Patient with compartment syndrome
of the lower extremity. J Wound Ostomy Continence Nurs 2002
Jul;29(4):210-5. |
|
|
√ |
Case report |
|
| (763) |
Whelan C, Stewart J, Schwartz BF. Mechanics of wound healing
and importance of Vacuum Assisted Closure in urology. J Urol
2005 May;173(5):1463-70. |
|
|
√ |
Narrative |
|
| (764) |
White RA, Miki RA, Kazmier P, Anglen JO. Vacuum-assisted
closure complicated by erosion and hemorrhage of the anterior
tibial artery. J Orthop Trauma 2005 Jan;19(1):56-9. |
|
|
√ |
Case report |
|
| (765) |
Whitney J, Phillips L, Aslam R, Barbul A, Gottrup F, Gould
L, Robson MC, Rodeheaver G, Thomas D, Stotts N. Guidelines
for the treatment of pressure ulcers. Wound Repair Regen
2006 Nov-Dec;14(6):663-79. |
|
|
√ |
Guideline |
|
| (116) |
Wild T, Stremitzer S, Budzanowski A, Hoelzenbein T, Ludwig
C,Ohrenberger G. Definition of efficiency in vacuum therapy
- A randomised controlled trial comparing Redon drains with
V.A.C. Therapy™. Int Wound J 2008 Dec;5(5):641-7. |
√ |
KQ2 |
|
|
|
| (766) |
Wilkes R, Zhao Y, Kieswetter K, Haridas B. Effects of Dressing
Type on 3D Tissue Microdeformations During Negative Pressure
Wound Therapy: A Computational Study. J Biomech Eng 2009
Mar;131(3):031012. |
|
|
√ |
Not a clinical study |
|
| (767) |
Willy C, Voelker HU, Engelhardt M. Literature on the subject
of vacuum therapy: review and update 2006. Eur J Trauma Emerg
Surg 2007 Feb;33(1):33-9. |
|
|
√ |
Not relevant - not a systematic review of wound healing
data |
|
| (768) |
Wiseman J, Cullington JR, Schaeferle M 3rd, Beckham PH,
Salisbury M, Ersek RA. Aesthetic aspects of neurofibromatosis
reconstruction with the vacuum-assisted closure system. Aesthetic
Plast Surg 2001 Sep-Oct;25(5):326-31. |
|
|
√ |
Case Report |
|
| (769) |
Wolvos T. Wound instillation with negative pressure wound
therapy. Ostomy Wound Manage 2005 Feb;51(2A Suppl):21S-6S. |
|
|
√ |
Narrative |
|
| (770) |
Wolvos T. Wound instillation—the next step in negative
pressure wound therapy. Lessons learned from initial experiences.
Ostomy Wound Manage 2004 Nov;50(11):56-66. |
|
|
√ |
Narrative |
|
| (161) |
Wondberg D, Larusson HJ, Metzger U, Platz A, Zingg U. Treatment
of the open abdomen with the commercially available vacuum-assisted
closure system in patients with abdominal sepsis: low primary
closure rate. World J Surg 2008 Dec;32(12):2724-9. |
√ |
KQ3 |
|
|
|
| (771) |
Wong LK, Nesbit RD, Turner LA, Sargent LA. Management of
a circumferential lower extremity degloving injury with the
use of vacuum-assisted closure. South Med J 2006 Jun;99(6):628-30. |
|
|
√ |
Case Report |
|
| (75) |
Wongworawat MD, Schnall SB, Holtom PD, Moon C, Schiller
F. Negative pressure dressings as an alternative technique
for the treatment of infected wounds. Clin Orthop Relat Res
2003 Sep;(414):45-8. |
√ |
KQ3 |
|
|
√ |
| (772) |
Woo KY, Sibbald RG. Vacuum-assisted closure home care training:
a process to link education to improved patient outcomes.
Int Wound J 2008 Jun;5 Suppl 2:1-9. |
|
|
√ |
Narrative |
|
| (773) |
Wound wonder. Middle East Medical 2003 May-Jun;61-5. |
|
|
√ |
Narrative |
|
| (774) |
Wu S. Case study: treating a patient with a diabetic neuropathic
ulceration. APMA News 2005 May;26(5-Suppl):19. |
|
|
√ |
Case Report |
|
| (775) |
Wu SC, Lavery LA, Armstrong DG. Closing difficult wounds.
Podiatry Today 2006 Mar;19(3):44-54. |
|
|
√ |
Narrative |
|
| (776) |
Wu Sc, Yoon H, Armstrong DG. Therapy with advanced modalities:
can it expedite healing?. Podiatry Today 2005 Sep;18(9):18-24. |
|
|
√ |
Narrative |
|
| (158) |
Wu SH, Zecha PJ, Feitz R, Hovius SE. Vacuum therapy as
an intermediate phase in wound closure: A clinical experience.
Eur J Plastic Surg 2000 May;23(4):174-7. |
√ |
KQ3 |
|
|
|
| (777) |
Wustmann O, Ulrich HC. German patent specification. Appliance
for the drainage of wounds. No. 847 475 Class 30 K Group
17 04. 1952 |
|
|
√ |
Not relevant |
|
| (72) |
Yang CC, Chang DS, Webb LX. Vacuum-assisted closure for
fasciotomy wounds following compartment syndrome of the leg.
J Surg Orthop Adv 2006 Spring;15(1):19-23. |
√ |
To be included in KQ3 |
|
|
|
| (778) |
Yoong S, Dunne G, Cochrane J, Lee B, Lee J. Vacuum-assisted
closure for the treatment of parastomal skin necrosis: a
novel approach to an unusual complication. Report of a case.
Dis Colon Rectum 2008 Oct;51(10):1577-9. |
|
|
√ |
Case report |
|
| (779) |
Yousaf M, Witherow A, Gardiner KR, Gilliland R. Use of
vacuum-assisted closure for healing of a persistent perineal
sinus following panproctocolectomy: report of a case. Dis
Colon Rectum 2004 Aug;47(8):1403-7; discussion 1407-8. |
|
|
√ |
Case report |
|
| (780) |
Yuan-Innes MJ, Temple CL, Lacey MS. Vacuum-assisted wound
closure: a new approach to spinal wounds with exposed hardware.
Spine 2001 Feb 1;26(3):E30-3. |
|
|
√ |
Fewer than five patients |
|
| (781) |
Yuh DD, Albaugh M, Ullrich S, Conte JV. Treatment of ventricular
assist device driveline infection with vacuum-assisted closure
system. Ann Thorac Surg 2005 Oct;80(4):1493-5. |
|
|
√ |
Case report |
|
| (782) |
Zamierowski D. United States Patent. Wound dressing and
treatment method. No. 4969880. 1990. |
|
|
√ |
Patent |
|
| (783) |
Zehnder SW, Place HM. Vacuum-assisted wound closure in
postoperative spinal wound infection. Orthopedics 2007 Apr;30(4):267-72. |
|
|
√ |
Narrative |
|
| (784) |
Zutt M, Haas E, Kruger U, Distler M, Neumann C. Successful
use of vacuum-assisted closure therapy for leg ulcers caused
by occluding vasculopathy and inflammatory vascular diseases—a
case series. Dermatology 2007;214(4):319-24. |
|
|
√ |
Case reports |
|
Return to Top
Figure 8 . Disposition of Submission by CMS
![Select [D] below for full text description of this figure.](npwtdfig8.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Return to Top
Table 45. Status of CMS
submission: Publications
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not Identified
in ECRI Search |
| (792) |
Biblehimer HL. Dealing with a wound that drains
1.5 liters a day. RN 1986 Aug;49(8):21-3. |
|
|
√ |
Case study/ Technical description |
|
| (114) |
Braakenburg A, Obdeijn MC, Feitz R, van Rooij
IA, van Griethuysen AJ, Klinkenbijl JH. The clinical efficacy
and cost effectiveness of the vacuum-assisted closure technique
in the management of acute and chronic wounds: a randomized
controlled trial. Plast Reconstr Surg 2006 Aug;118(2):390-7;
discussion 398-400. |
√ |
KQ1, KQ3 |
|
|
|
| (442) |
Chariker ME, Jeter KF, Tintle TE, Bottsford
JE. Effective management of incisional and cutaneous fistulae
with close suction wound drainage. Contemp Surg 1989 Jun;34:59-63. |
|
|
√ |
Case series/ Technical description |
|
| (793) |
Coleman D. No wound is too big for resourceful
nurses. RN 1988 Dec;51(12):22-5. |
|
|
√ |
Case study/ Technical description |
|
| (110) |
Ford C, Reinhard E, Yeh D, Syrek D, de las Morenas A, Bergman
S, Williams S, Hamori C. Interim analysis of a prospective
randomized trial of vacuum-assisted closure versus the healthpoint
system in the management of pressure ulcers. Ann Plast Surg
2002;49(1):7 p. |
√ |
KQ1, KQ3 |
|
|
|
| (794) |
Garcia-Rinaldi R, Defore WW Jr, Green ZD, McBride C. Improving
the efficiency of wound drainage catheters. Am J Surg 1975
Sep;130(3):372-3. |
|
|
√ |
Case study/ Technical description |
|
| (795) |
Miller MS, Lowery CA. Negative pressure wound therapy:
'a rose by any other name'. Ostomy Wound Manage 2005 Mar;51(3):44-6,
48-9. |
|
|
√ |
Narrative review |
|
| (796) |
Q209 hospital purchasing manager survey. Charlotte (NC):
Wachovia Capital Markets, LLC; 2009 Apr 7. 13 p. |
|
|
√ |
Survey |
|
| (797) |
Q2 2008 wound care nurse survey. Charlotte (NC): Wachovia
Capital Markets, LLC; 2008 May 21. 13 p. |
|
|
√ |
Survey |
|
| (798) |
Q208 hospital purchasing manager survey. Charlotte (NC):
Wachovia Capital Markets, LLC; 2008 Apr 21. 16 p. |
|
|
√ |
Survey |
|
| (799) |
Q4 2007 wound care nurse survey. Charlotte (NC): Wachovia
Capital Markets, LLC; 2007 Dec 6. 11 p. |
|
|
√ |
Survey |
|
| (800) |
Q4 2008 wound care nurse survey. Charlotte (NC): Wachovia
Capital Markets, LLC; 2008 Dec 1. 15 p. |
|
|
√ |
Survey |
|
| (801) |
RAFFL AB. The use of negative pressure under skin flaps
after radical mastectomy. Ann Surg 1952 Dec;136(6):1048. |
|
|
√ |
Case study/ Technical description |
|
| (802) |
Ramirez OM, Granick MS, Futrell JW. Optimal wound healing
under Op-Site dressing. Plast Reconstr Surg 1984 Mar;73(3):474-5. |
|
|
√ |
Case study/ Technical description |
|
| (182) |
Samson D, Lefevre F. Wound-healing technologies: low-level
laser and vacuum-assisted closure. Rockville (MD): Agency
for Healthcare Research and Quality (AHRQ); 2004. |
√ |
Previous Systematic Reviews |
|
|
|
| (34) |
Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill
DP. Vacuum-assisted closure: microdeformations of wounds
and cell proliferation. Plast Reconstr Surg 2004 Oct;114(5):1086-96;
discussion 1097-. |
|
|
√ |
Case study/Technical description |
|
| (803) |
Schwab PM, Kelly KA. Primary closure of the perineal wound
after proctectomy. A new technique. Mayo Clin Proc 1974 Mar;49(3):176-9. |
|
|
√ |
Case study/ Technical description |
|
| (312) |
Sibbald RG, Mahoney J, V.A.C. Therapy Canadian Consensus
Group. A consensus report on the use of vacuum-assisted closure
in chronic, difficult-to-heal wounds. Ostomy Wound Manage
2003 Nov;49(11):52-66. |
√ |
|
√ |
Narrative |
|
| (804) |
VanDuren T. (Case Manager. University of Utah Health Plans & Healthy-U).
BlueSky Versatile One. Case study. University of Utah. 2004
Jan 13. 7 p. |
|
|
√ |
Case study |
|
| (805) |
Wolvos T. Feature: wound instillation-the next step in
negative pressure wound therapy. Lessons learned from initial
experiences. Ostomy Wound Manag 2004;50(11):56-66. |
|
|
√ |
Case study/ Technical description |
|
KQ = Key question
Return to Top
Table 46. Status of CMS
submission: Government Documents
| Reference Number |
Reference |
Disposition in Report |
| (806) |
Beninger P. (Director. Division of General
and Restorative Devices. Office of Device Evaluation. Center
for Devices and Radiological Health). 510(k) notification
of intent to market VACPLUS. K945062. 1995 Mar 14. 50 p. |
Used as background information |
| (807) |
Bowman J. Personal Communication. FDA account
of NPNT safety issues as summarized by CMS. 2005. 1 p. |
Not used in this report |
| (808) |
Dillard J. (Acting Director. Division of General
and Restorative Devices. Office of Device Evaluation. Center
for Devices and Radiological Health). Approval of 510(k)
notification of intent to market. V.A.C. plus. K992448. 2000
Jan 18. 3 p. |
Used as background information |
| (809) |
Food and Drug Administration, Center for Devices
and Radiological Health. Guidance document for powered suction
pump 510(k)s. Rockville (MD): Food and Drug Administration,
Center for Devices and Radiological Health; 1998. 5 p. |
Not used in this report |
| (810) |
Food and Drug Administration, Center for Devices
and Radiological Health. 510(k) premarket notification database.
Annelid. K940886. [internet]. Silver Spring (MD): Food and
Drug Administration, Center for Devices and Radiological
Health; 2002 Nov 5 [updated 2009 Jan 16]; [accessed 2002
Nov 5]. [1 p]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=96760. |
Used as background information |
| (811) |
Food and Drug Administration, Center for Devices
and Radiological Health. 510(k) premarket notification database.
Vacuum assisted closure. K021500. [internet]. Silver Spring
(MD): Food and Drug Administration, Center for Devices and
Radiological Health; 2002 Dec 20 [accessed 2005 Nov 11].
[5 p]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8137. |
Used as background information |
| (812) |
Food and Drug Administration. 510 (k) summary
statement. V.A.C. plus device, 510(k) No. K945062. [database
online]. Silver Spring (MD): Food and Drug Administration;
2000 Jan 18 [2 p]. |
Used as background information |
| (813) |
Hake C. (Director, CMS HCPCS Workgroup). Personal
communication. Request to establish a code for portable powered
suction pump, trade name: versatile wound vacuum system.
2005. 2 p. |
Not used in this report |
| (814) |
Hake C. (Director. CMS HCPCS Workgroup). Personal
Communication. Request to establish three new codes for negative
pressure wound therapy (NPWT) pumps, canisters and dressings
which provide wound site pressure feedback. 2006. 2 p. |
Not used in this report |
| (815) |
Hake C. Doctors interviewed by the house ways
and means reportedly support foam as superior to gauze. 2008.
3 p. |
Not used in this report |
| (816) |
Harbour J, Kinetic Concepts, Inc.. 510 (k)
Summary. Ambulatory Suction Pump. 1997 May 22. 5 p. |
Used as background information |
| (817) |
Smith T. Kinetic Concepts patent not infringed.
2006. 1 p. |
Not used in this report |
| (818) |
United States patent and trademark office.
V.A.C.. United States Patent and Trademark Office; 1996 Jun
25. 33 p. |
Not used in this report |
| (819) |
Wilson C. Personal communication. FW: Alliance
for LTC on Wound VAC/NPWT. 2006. 2 p. |
Not used in this report |
| (820) |
Witten C. (Director. Division of General and
Restorative Devices, Office of Device Evaluation, Center
for Devices and Radiological Health). Approval of 510(k)
notification of intent to market. AmbuVAC Device. 1997 May
22. 3 p. |
Used as background information |
| (821) |
Witten C. (Director. Division of General,
Restorative and Neurological Devices, Office of Device Evaluation,
Center for Devices and Radiological Health). Approval of
510(k) notification of intent to market. V.A.C. family of
devices: mini V.A.C. .V.A.C. Freedom V.A.C. ATS. K032310.
2003 Oct 10. 5 p. |
Used as background information |
| (822) |
Witten C. (Director. Division of General,
Restorative and Neurological Devices. Office of Device Evaluation.
Center for Devices and Radiological Health). 510(k) notification
of intent to market Versatile 1 Wound Vacuum System. K042134.
2004 Nov 15. 7 p. |
Used as background information |
| (823) |
Witten C. (Director. Division of General,
Restorative and Neurological Devices, Office of Device Evaluation,
Center for Devices and Radiological Health). Approval of
510(k) notification of intent to market. V.A.C. granufoam
silver dressing. K041642. 2005 Jan 25. 3 p. |
Used as background information |
Return to Top
Table 47. Status of CMS
submission: Miscellaneous Material
| Reference Number |
Reference |
Disposition in Report |
| (824) |
AllegroMedical.com. Invacare aspirator product
description. [internet]. Mesa (AZ): AllegroMedical.com; 2005
[accessed 2005 Aug 15]. Available: http://www.allegromedical.com/oxygen_therapy/nebulizers/invacare/aspirator.P189899. |
Not used in this report |
| (825) |
BlueSky Medical Group, Inc.. Negative pressure
wound therapy. V1STA Versatile 1 portable. Carlsbad (CA):
BlueSky Medical Group, Inc.; 2005. 4 p.—product brochure |
Used as background information |
| (826) |
Hake C. (Director, CMS' HCPCS Workgroup).
Personal communication. Negative pressure wound therapy devices.
2008 Jan 23. 5 p. Includes list of materials submitted by
CMS for this report. |
Personal communication |
| (827) |
Kinetic Concepts, Inc.. Advanced Dressings.
Dedicated dressings for specific wound applications. San
Antonio (TX): Kinetic Concepts, Inc. (KCI); 2005. 6 p. —product
brochure |
Used as background information |
| (828) |
Kinetic Concepts, Inc.. V.A.C. A portable
system for advanced wound healing. San Antonio (TX): Kinetic
Concepts, Inc. (KCI); 2005. 6 p. —product brochure |
Used as background information |
| (829) |
Lewis P. Smith & Nephews acquires BlueSky
medical group. Remington Rep 2007; news release |
Not used in this report |
| (830) |
Medela, Inc.. Medela Clario home care pump.
Product Description. [internet]. MCHenry (IL): Medela, Inc.;
2005 [accessed 2005 Sep 16]. [1 p].—product brochure |
Used as background information |
| (831) |
United Publications, Inc.. Are negative pressure
wound therapy codes created equal?. [internet]. Yarmouth
(ME): United Publications, Inc.; 2009 [accessed 2009 Jan
12]. [3 p].—news report |
Not used in this report |
| |
V.A.C. Annotated Peer-reviewed Article Bibliography
prepared by KCI |
We examined the bibliography for studies not
identified in our searches |
| (832) |
Weston R. (President, BlueSky Medical). Personal
Communication. BlueSky medical wound drainage kit. 2003.
5 p.—also included product information and brochure |
Used as background information |
Return to Top
Table 48. Status of CMS
submission: Material from KCI or related to KCI
| Reference Number |
Reference |
Disposition in Report |
| (833) |
Cynthia S. Hake. CMS meeting with KCI. 2005.
68 p. KCI presentation to CMS comparing V.A.C. to BlueSky
Versatile 1 |
Not used in
this report |
| (834) |
House small business subcommittee on rural
and urban entrepreneurship. Statement by Linwood A. Staub,
President, Global V.A.C therapy, Kinetic Concepts, Inc. (KCI)
on behalf of the Advanced Medical Technology Association
(AdvaMed). Washington (DC): U.S. House of Representatives;
2008 May 21. 11 p. Also available: http://www.house.gov/smbiz/hearings/hearing-05-21-08-DME/Staub.pdf. [Plugin Software Help] |
Not used in
this report |
| (835) |
Kinetic Concepts, Inc. (KCI). Personal Communication.
KCI comments on CMS' preliminary decision to include BlueSky
and KCI NPNT devices in the same code. 2005. 20 p. |
Not used in
this report |
| (836) |
Kinetic Concepts, Inc. Personal communication.
Comments following the June 23, 2005 CMS HCPCS workgroup
meeting agenda item #11; HCPCS request #05.09. 2005. 3 p. |
Not used in
this report |
| (836) |
Kinetic Concepts, Inc.. Personal communication.
Comments following the June 23, 2005 CMS HCPCS workgroup
meeting agenda item #11; HCPCS request #05.09. 2005. 3 p.
KCI comments regarding BlueSky V1 |
Not used in
this report |
| (837) |
Larichev A. Vacuum therapy in wounds and wound
infection: negative pressure wound therapy.Carlsbad (CA):
BlueSky Publication; 2005 [2 p]. - page from Library of Congress
Online Catalog |
Not used in this report |
| (838) |
Matherne C. (Senior Attorney. LSU, Health
Sciences Center). Personal Communication. V.A.C. System.
Medical center of Louisiana. 2001 Sep 21. 1 p. |
Not used in
this report |
| (869) |
Morris S. (Vice President, Health policy & Government
Affairs KCI). Personal communication. Public meeting registration
for KCI. 2006. 1 p. |
Not used in
this report |
| (840) |
Morris S. (Vice President, Reimbursement Policy
and Compliance). Personal Communication. HCPCS code request
for negative pressure wound therapy pumps. 2006. 4 p. |
Not used in
this report |
| (841) |
Morris S. Additional V1 failures/VAC rescues.
2006. 2 p. Case reports submitted by KCI to CMS |
Not used in
this report |
| (942) |
Moton T. (Briefing Coordinator). Meeting with
Kinetic Concepts Incorporated (KCL). 2006. 30 p. KCI presentation
to CMS |
Not used in
this report |
| (843) |
NPWT HCPCS coding: KCI V.A.C. therapy system.
Update for the Centers for Medicare and Medicaid Services.
San Antonio (TX): Kinetic Concepts, Inc. (KCI); 2006. 173
p. KCI submission to CMS |
Not used in
this report |
| (844) |
Quirk, W. Personal Communication. VAC plus
premarket notification No. K945062. 2002 Oct 22. 4 p. Letter
sent from KCI to BlueSky. |
Not used in
this report |
| (845) |
Schroeder, W. (Vice President, Medical Department,
Kinetic Concepts, Inc.). Misuse of the V.A.C technology.
2000 Feb 01. 2 p. |
Not used in
this report |
| (846) |
Tarplin R. Letters that raise concerns about
the CMS HCPCS coding decision. 2006. 83 p. Letters from Congress
and clinicians sent to CMS. |
Not used in
this report |
Return to Top
Table 49. Status of CMS
submission: Material from BlueSky or related to BlueSky
| Reference Number |
Reference |
Disposition
in Report |
| (847) |
BlueSky Medical Group, Inc. HCPSC coding request
Versatile 1 wound vacuum system. Carlsbad (CA): BlueSky Medical
Group, Inc.; 2005. 5 p.—BlueSky presentation to CMS |
Not used in
this report |
| (848) |
BlueSky Medical. Information for Centers for
Medicare and Medicaid Services on negative pressure wound
therapy. Baltimore (MD): BlueSky Medical; 2002 Oct 25. 45
p.—package of information sent to CMS by BlueSky
Medical |
Not used in
this report |
| (849) |
Guimond J. (Marketing & Sales. BlueSky
Medical Group, Inc.). Personal Communication. BlueSky's product
line, VISTA Versatile 1 portable. 2006. 3 p.—announcement
about failure of KCI infringement lawsuit |
Not used in
this report |
| (850) |
Weston R. (President. BlueSky Medical Group,
Inc.). Personal Communication. Petition and request to decrease
reimbursement levels. 2002 Jun 11. 2 p. |
Not used in
this report |
| (851) |
Weston R. Personal communication. BlueSky's
2005 HCPCS code request. 2004. 5 p. |
Not used in
this report |
Return to Top
Figure 9 . Disposition of Submission by ConvaTec
![Select [D] below for full text description of this figure.](npwtdfig9.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Return to Top
Table 50. Status of Submission
by ConvaTec
| Reference Number |
Reference |
Included |
Placement in Report |
Disposition in Report |
| (852) |
Engenex Advanced Negative Pressure Wound Therapy
System.
Instructions for use. Skillman (NJ): ConvaTec, Inc.; 2008
Dec. 33 p.—product information |
√ |
Background |
|
| (853) |
Rolley J. (Vice President, Global Government
Affairs and Health Policy, ConvaTec). Personal communication.
2009 Feb 6. 3 p. |
|
|
Not included in this report—personal
communication |
| (732) |
- Summaries of current clinical evidence Engenex NPWT
system.
Skillman (NJ): ConvaTec, Inc.; 3 p.
- ConvaTec provided 6 references to poster presentations
at wound care meetings. A total of 14 patients of various
wound types were treated with the Engenex® NPWT system
using the Bio-Dome™ dressing set.
|
|
|
Not included in this report—poster
presentation |
Return to Top
Figure 10 . Disposition of Submission by Individuals
![Select [D] below for full text description of this figure.](npwtdfig10.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Return to Top
Table 51. Status of Submission
by Individuals
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not identified
in ECRI Search |
| (854) |
Andersen C. (Chief Vascular/Endovascular/LimbPreservation
Surgery Service, Madigan Army Medical Center. Ft. Lewis,
WA). Personal communication. Re: AHRQ review of NPWT. 2009
Feb 6. 2 p. |
|
|
√ |
Personal communication |
|
| (855) |
Annest S. (MD, FACS. Denver, CO). Personal communication.
NPWT Comments from Annest. 2009 Feb 3. 1 p. |
|
|
√ |
Personal communication |
|
| (195) |
Armstrong DG, Lavery LA, Diabetic Foot Study Consortium.
Negative pressure wound therapy after partial diabetic foot
amputation: a multicentre, randomised controlled trial. Lancet
2005 Nov 12;366(9498):1704-10. |
|
|
√ |
Study population reported in(109) |
|
| (856) |
Arnold DA. (Midwest Hernia Institute, P.C.). Personal communication.
Comments on NPWT from Midwest Hernia Institute. 2009 Jan
30. 1 p. |
|
|
√ |
Personal communication |
|
| (857) |
Bernstein BH. (DPM, FACFAS). Personal communication. Comparison
of types of NPWT, limb salvage specialist’s point of
view. 2009 Feb 4. 2 p. |
|
|
√ |
Personal communication |
|
| (108) |
Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison
of negative pressure wound therapy using vacuum-assisted
closure with advanced moist wound therapy in the treatment
of diabetic foot ulcers: a multicenter randomized controlled
trial. Diabetes Care 2008 Apr;31(4):631-6. |
√ |
KQ1, KQ3 |
|
|
|
| (858) |
Chaiken N. (Wound Ostomy Continence, Swedish Covenant Hospital).
Personal communication. Comments on wound VACs. 2009 Feb
3. 1 p. |
|
|
√ |
Personal communication |
|
| (859) |
Clinical V.A.C. therapy slides from the practice of Dr.
C. Douglas Fogg, MD, FACS. New Bedford (MA): New Bedford
Rehabilitation Hospital Wound Care Center; 14 p. |
|
|
√ |
Case studies |
|
| (860) |
Coliauta EA. Personal communication. Support of KCI wound
VAC system. 2009 Feb 6. 1 p. |
|
|
√ |
Personal communication |
|
| (861) |
Cummings SF. (Director, Wound Recovery and Hyperbaric Medicine
Service, Kent Hospital. Warwick, RI). Personal communication.
NPWT Response from Kent Hospital. 2009 Jan 30. 1 p. |
|
|
√ |
Personal communication |
|
| (862) |
DosRemedios E. (Clinical Assistant Professor of Orthopaedic
Surgery, Warren Alpert School of Medicine at Brown University.
Providence, Rhode Island.). Personal communication. Comments
on NPWT from Brown University. 2009 Feb 2. 1 p. |
|
|
√ |
Personal communication |
|
| (863) |
Fetterly MA. (RNFA, CPSN, CNOR. O Plastic & Reconstructive
Surgery. Reno, NV). To AHRQ in regards to KCI VAC devices.
2009 Jan 29. 1 p. |
|
|
√ |
Personal communication |
|
| (362) |
Fleck T, Kickinger B, Moidl R, Waldenberger F, Wolner E,
Grabenwoger M, Wisser W. Management of open chest and delayed
sternal closure with the vacuum assisted closure system:
Preliminary experience. Interact Cardiovasc Thorac Surg 2008
Oct;7(5):801-4. |
√ |
KQ3 |
|
|
|
| (496) |
Fleck T, Moidl R, Giovanoli P, Aszmann O, Bartunek A, Blacky
A, Grabenwoger M, Wolner E. A conclusion from the first 125
patients treated with the vacuum assisted closure system
for postoperative sternal wound infection. Interact Cardiovasc
Thorac Surg 2006 Apr;5(2):145-8. |
|
|
√ |
Narrative |
|
| (497) |
Fleck T, Simon P, Burda G, Wolner E, Wollenek G. Vacuum
assisted closure therapy for the treatment of sternal wound
infections in neonates and small infants. Interact Cardiovasc
Thorac Surg 2006 Jun;5(3):285-8. |
|
|
√ |
Fewer than five patients |
|
| (864) |
Fleck T. (Department of Cardiothoracic Surgery, AKH
Vienna, Medical University of Vienna). Response to the
review of NPWT of the AHRQ. 2009 Jan 29. 1 p.
Dr. Fleck provided a list of 12 studies and
abstracts. These were reviewed for possible inclusion. |
|
|
√ |
Five studies with Dr. Fleck as the first author were considered
for this report. Two were included(286,304) and three were
excluded.(420-422) |
|
| (380) |
Fleck TM, Fleck M, Moidl R, Czerny M, Koller R, Giovanoli
P, Hiesmayer MJ, Zimpfer D, Wolner E, Grabenwoger M. The
vacuum-assisted closure system for the treatment of deep
sternal wound infections after cardiac surgery. Ann Thorac
Surg 2002 Nov 1;74(5):1596-1600. |
√ |
KQ3 |
|
|
|
| (498) |
Fleck TM, Koller R, Giovanoli P, Moidl R, Czerny M, Fleck
M, Wolner E, Grabenwoger M. Primary or delayed closure for
the treatment of poststernotomy wound infections. Ann Plast
Surg 2004 Mar;52(3):310-4. |
|
|
√ |
Not relevant |
|
| (865) |
Fogg CD. (Medical Director, New Bedford Rehabilitation
Hospital Wound Care Center). Advocacy for V.A.C. therapy.
1 p. |
|
|
√ |
Personal communication |
|
| (866) |
Gestring M, Manaker S, Wilson KC. Vacuum assisted wound
closure [unpublished]. 2008 Apr 10. 7 p. |
|
|
√ |
Narrative |
|
| (341) |
Lavery LA, Boulton AJ, Niezgoda JA, Sheehan P. A comparison
of diabetic foot ulcer outcomes using negative pressure wound
therapy versus historical standard of care. Int Wound J 2007
Jun;4(2):103-13. |
√ |
KQ1, KQ3 |
|
|
|
| (867) |
Marston WA. (Professor and Chief, Division of Vascular
Surgery, University of North Carolina School of Medicine.
Chapel Hill, NC). Personal communication. Review of Negative
Pressure Wound Therapy devices. 2009 Feb 3. 1 p. |
|
|
√ |
Personal communication |
|
| (868) |
Mooney TM. (DPM, AACFAS, Western Nevada Foot & Ankle
Center, LLC. Reno, NV). Personal communication. 2009. 1 p. |
|
|
√ |
Personal communication |
|
| (869) |
Nelson G. (Program Coordinator, Advanced Wound Center,
Rogue Valley Medical Center. Medford, OR). Personal communication.
Concerns about negative pressure therapy. 2009 Feb 5. 2 p. |
|
|
√ |
Personal communication |
|
| (870) |
Pelham FR. (Department of Orthopedic Surgery, Musculoskeletal
Research Center, New York University Hospital for Joint Diseases,
New York, NY). Personal communication. Re: VAC therapy. 2009
Feb 6. 13 p.
Dr. Pelham provided a manuscript describing a
retrospective case-series of patients with stage III and
IV pressure ulcers treated with V.A.C. therapy, but requested
that the data not be shared with the public. |
|
|
√ |
The study provided by Dr. Pelham was not included in the
report. The study did not address Key Questions 1, 2, or
4. The study could have been considered under Key Question
3, but the study did not report that they collected data
on complications. |
|
| (671) |
Poulakidas S, Kowal-Vern A. Facilitating residual wound
closure after partial graft loss with vacuum assisted closure
therapy. J Burn Care Res 2008 Jul-Aug;29(4):663-5. |
|
|
√ |
Case report |
|
| (871) |
Ritzman D. (Fremont-Rideout Home Health). Personal communication.
HCPS code for KCI Wound Vac. 2009 Jan 31. 1 p. |
|
|
√ |
Personal communication |
|
| (872) |
Robins M. (Wound Care Clinic at Utah Valley Regional Medical
Center). NPWT study. 2009 Feb 6. 4 p.
Dr. Robins provided a review of NPWT(791) and
three publications.(174,183,194) |
|
|
√ |
A review of NPWT(791) and three publications.(174,183,194) |
|
| (308) |
Schlatterer D, Hirshorn K. Negative pressure wound therapy
with reticulated open cell foam-adjunctive treatment in the
management of traumatic wounds of the leg: a review of the
literature. J Orthop Trauma 2008 Nov-Dec;22(10 Suppl):S152-60. |
|
|
√ |
Review article |
|
| (873) |
Schultz G. (Professor, Department of Obstetrics and Gynecology,
Institute for Wound Research, University of Florida. Gainesville,
FL). Personal communication. Re: scientific data on effects
of NPWT. 2009 Feb 6. 1 p.
Dr. Schultz provided references to two publications. |
|
|
√ |
The publications were not used in this report because they
did not report wound healing outcomes considered in this
report |
|
| (874) |
Snow R. (Director, Baptist Wound Care & Hyperbaric
Medicine Program @ Princeton). Personal communication Re:
negative pressure Rx. 2009 Feb 3. 1 p. |
|
|
√ |
Personal communication |
|
| (738) |
Tarkin IS. The versatility of negative pressure wound therapy
with reticulated open cell foam for soft tissue management
after severe musculoskeletal trauma. J Orthop Trauma 2008
Nov-Dec;22(10 Suppl):S146-51. |
|
|
√ |
Case reports |
|
| (875) |
Tedford S. (WOCN Program Coordinator, Sutter VNA & Hospice).
Personal communication. HCPCS code response from WOCN. 2009
Jan 30. 1 p. |
|
|
√ |
Personal communication |
|
| (106) |
Timmers MS, Graafland N, Bernards AT, Nelissen RGHH, Van
Dissel JT, Jukema GN. Negative pressure wound treatment with
polyvinyl alcohol foam and polyhexanide antiseptic solution
instillation in posttraumatic osteomyelitis. Wound Repair
Regen 2009 Mar-Apr;17(2):278-86. |
√ |
Key Question 1 |
|
|
√ |
| (174) |
Ubbink DT, Westerbos SJ, Evans D, Land L, Vermeulen H.
Topical negative pressure for treating chronic wounds (Review).
In: Cochrane Database of Systematic Reviews [internet]. Issue
3. Hoboken (NJ): John Wiley & Sons, Ltd.; 2008 [Art.
No.: CD001898]. |
√ |
Previous Systematic Reviews |
|
|
|
| (183) |
Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen H. A systematic
review of topical negative pressure therapy for acute and
chronic wounds. Br J Surg 2008 Jun;95(6):685-92. |
√ |
Previous Systematic Reviews |
|
|
|
| (876) |
Ward RS. (President, American Physical Therapy Association.
Alexandria, VA). APTA's response to AHRQ's request for information
on Negative Pressure Wound Therapy. 2009 Feb 4. 2 p.
Dr. Ward provided copies of six publications, all identified
by our searches; three were included in the report and
three were excluded.
Included publications:(75,108,265)
Excluded publications:
(663)—case reports
(248)—review article
(596)—case report |
|
|
√ |
Cover letter |
|
| (75) |
Wongworawat MD, Schnall SB, Holtom PD, Moon C, Schiller
F. Negative pressure dressings as an alternative technique
for the treatment of infected wounds. Clin Orthop Relat Res
2003 Sep;(414):45-8. |
√ |
KQ3 |
|
|
|
| (877) |
Yee EM. (Sierra Infectious Diseases, Reno, NV). Personal
communication. Comments on proposed code change. 2009 Jan
30. 1 p. |
|
|
√ |
Personal communication |
|
Return to Top
Figure 11 . Disposition of Submission by Medela, Inc.
![Select [D] below for full text description of this figure.](npwtdfig11.gif)
[D] Select for Text
Description
Note: Language has been corrected to reflect
screening of meeting abstracts, poster presentations and other
documents in addition to abstracts and full articles.
Return to Top
Table 52. Status of Submission
by Medela
| Reference Number |
Reference |
Included |
Excluded |
Reason for Exclusion |
| (878) |
Best practice statement: gauze-based negative
pressure wound therapy. HealthComm UK Limited; 2008 Nov.
19 p. |
|
√ |
Narrative review |
| (879) |
Case study 2: Four challenging LE wounds:
can these chronic wounds be healed with use of negative pressure
wound therapy. McHenry (IL): Medela Healthcare, Inc.; 1 p. |
|
√ |
Case study |
| (880) |
Case study: gauze-based NPWT: various wound
types from different wound locations. McHenry (IL): Medela
Healthcare, Inc.; 1 p. |
|
√ |
Case study |
| (881) |
Comparative analysis of gauze-based NPWT systems
versus foam-based NPWT systems. McHenry (IL): Medela Healthcare,
Inc.; 7 p.—A short description of a retrospective
analysis of 55 patients treated with the Invia® wound
Therapy system. |
|
√ |
Insufficient reporting of study design and
results |
| (882) |
Gauze based clinical study 1: Safety and effectiveness
of the Invia (vacuum) wound care system versus a saline wet-to-dry
gauze dressing. McHenry (IL): Medela Healthcare, Inc.; 5
p. |
|
√ |
Protocol for planned RCT |
| (883) |
Gauze based clinical study 2: Gauze versus
foam for topical negative pressure wound therapy (NPWT) in
postoperative subcutaneous wound infections after abdominal
operations. First clinical observations. McHenry (IL): Medela
Healthcare, Inc.; 22 p. |
|
√ |
Case study |
| (884) |
Long C. (Director, Medela Healthcare. McHenry,
IL). Submission letter from Medlea Healthcare regarding NPWT.
2009 Feb 3. 1 p.—cover letter |
|
√ |
Cover letter |
| (885) |
McHenry (IL): Medela Healthcare; 2009. Introduction
to NPWT. p. 3.—short discussion of NPWT |
|
√ |
Narrative |
| (886) |
Pre-clinical study: a comparison of various
dressings combined with NPWT. McHenry (IL): Medela Healthcare,
Inc.; 2008. 15 p. Also available: http://www.etrs.org/malta3.html. |
|
√ |
Animal study |
| (887) |
The effect of an antimicrobial gauze dressing
impregnated with 0.2% polyhexamethylene biguanide (PHMB)
as a barrier to prevent pseudomonas aeruginosa wound invasion.
McHenry (IL): Medela Healthcare, Inc.; 7 p. |
|
√ |
Animal study |
Return to Top
Figure 12 . Disposition of Submission by Prospera
![Select [D] below for full text description of this figure.](npwtdfig12.gif)
[D] Select for Text Description
Note: Language has been corrected to reflect screening of meeting abstracts, poster presentations and other documents in addition to abstracts and full articles.
Return to Top
Table 53. Status of Submissions
by Prospera
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not identified
in ECRI Search |
| (888) |
Advancing the art and science of NPWT. Fort
Worth (TX): Prospera; 2008. CD-ROM.—product information |
|
|
√ |
Product Information |
|
| (889) |
Ahearn C. (Director of Clinical Services,
Prospera). Prospera response to ECRI Institute's December
20, 2008 request for information regarding our Negative Pressure
Wound Therapy system. 2009 Feb 2. 1 p.—cover letter |
|
|
√ |
Cover letter |
|
| (890) |
Allison Hendrickson M, Reaves L, Ulbrich M.
Optimizing wound care by integrating negative pressure wound
therapy (NPWT), adjunctive topical treatments and surgical
debridement. Grapevine (TX): Ethicus Long Term Acute Care
Hospital; 1 p. |
|
|
√ |
Case study |
|
| (891) |
AMD antimicrobial gauze dressings [slide].
Fort Worth (TX): Prospera; 1 p. |
|
|
√ |
Not a NPWT device |
|
| (892) |
Bonham PA, Ramundo JM. Commentary: surgical
wound case studies with the Versatile 1 wound vacuum system
for negative pressure wound therapy. J Wound Ostomy Continence
Nurs 2006 Mar-Apr;33(2):185-90. |
|
|
√ |
Narrative
review |
|
| (893) |
Borgquist O, Torbrand C, Ingemansson R, Malmsjo
M. Biological effects of negative pressure wound therapy
(NPWT) at low levels of negative pressure - intermittent
and variable NPWT [confidential info prepared for ECRI on
behalf of AHRQ]. 2009 Feb. 5 p. |
|
|
√ |
Animal study |
|
| (894) |
Borgquist O, Torbrand C, Ingemansson R, Malmsjo
M. Biological effects of negative pressure wound therapy
at low levels of negative pressure - intermittent and variable
NPWT. 2 p. |
|
|
√ |
Animal study |
|
| (207) |
Bovill E, Banwell PE, Teot L, Eriksson E,
Song C, Mahoney J, Gustafsson R, Horch R, Deva A, Whitworth
I, International Advisory Panel on Topical Negative Pressure.
Topical negative pressure wound therapy: a review of its
role and guidelines for its use in the management of acute
wounds. Int Wound J 2008 Oct;5(4):511-29. |
|
|
√ |
Narrative
review |
|
| (84) |
Campbell PE, Smith GS, Smith JM. Retrospective
clinical evaluation of gauze-based negative pressure wound
therapy. Int Wound J 2008 Jun;5(2):280-6. |
√ |
KQ3 |
|
|
√ |
| (895) |
Case studies: Prospera PRO-I negative pressure
wound therapy [MR124-02/08]. Fort Worth (TX): Prospera; 2008.
7 p. |
|
|
√ |
Case study |
|
| (896) |
Caudill T. Clinical and economic benefit to
surgical patients with the use of an antimicrobial impregnated
surgical dressing. 2 p. |
|
|
√ |
Not a NPWT device |
|
| (442) |
Chariker ME, Jeter KF, Tintle TE, Bottsford
JE. Effective management of incisional and cutaneous fistulae
with close suction wound drainage. Contemp Surg 1989 Jun;34:59-63. |
|
|
√ |
Did not use a commercially available NPWT
system |
|
| (897) |
Clinical and patient testimonials [Confidential
info prepared for ECRI on behalf of AHRQ]. Fort Worth (TX):
Prospera; 2009 Feb. 5 p. |
|
|
√ |
Testimonials were not used in this report |
|
| (898) |
CPT - continuous pressure therapy [graph].
Fort Worth (TX): Prospera; 1 p. |
|
|
√ |
Graph |
|
| (461) |
Davydov YA, Larichev AB, Abramov AY, Menkov
KG. [Concepts for clinical biological management of the wound
process in the treatment of purulent wounds using vacuum
therapy] translated from Russian. Vestnik Khirurgii 1991
Feb;132-5. (Rus). |
|
|
√ |
Not a NPWT device |
|
| (462) |
Davydov YA, Larichev AB, Menlov KG. [The bacteriological
and cytological assessment of vacuum therapy of purulent
wounds] translated from Russian. Vestnik Khirurgii 1988 Oct;48-52. |
|
|
√ |
Not a NPWT device |
|
| (460) |
Davydov YA, Malafeeva EV, Smirnov AP, Flegontov
VB. [Vacuum therapy in the treatment of purulent lactation
mastitis] translated from Russian. Vestnik Khirurgii 1986
Sep;66-70. (Rus). |
|
|
√ |
Not a NPWT device |
|
| (899) |
Donahue K. (Administrative Assistant, Health
Technology Assessment Information Service and Evidence-Based
Practice Center, ECRI Institute. Plymouth Meeting, PA). ECRI
Institute's request for submissions on NPWT from interested
stakeholders. 2008 Dec 30. 2 p.—copy of letter from
ECRI Institute to Prospera |
|
|
√ |
Communication |
|
| (900) |
Eberlein T, Fedler H. Using a new technique
of negative pressure wound therapy (NPWT): variable pressure
therapy (VPT) for the management of chronic, non-healing
wounds [poster]. Neuremberg, Germany: Gesundheits Manager
Health and Wound Management; 1 p. |
|
|
√ |
Case study |
|
| (901) |
Eberlein T, Fendler H, Ahearn C. Using a new
technique for negative pressure wound therapy (NPWT) for
the management of chronic, non-healing wounds [poster]. Neuremberg,
Germany: Gesundheits Manager Health and Wound Management;
1 p. |
|
|
√ |
Case study |
|
| (902) |
Eberlein T, Fendler H, Ahearn C. Using a new
technique of negative pressure wound therapy (NPWT): variable
pressure therapy (VPT) for the management of chronic, non-healing
wounds. 4 p.—A short description of unpublished data
from a prospective analysis of 37 patients treated with the
Prospera® NPWT system. |
|
|
√ |
Insufficient reporting of study design and
results |
|
| (903) |
Etoz A, Ozgenel Y, Ozcan M. The use of negative
pressure wound therapy on diabetic foot ulcers: a preliminary
controlled trial. Wounds 2004 Aug;16(8):264-9. |
|
|
√ |
Did not use a commercially available NPWT
system |
|
| (811) |
Food and Drug Administration, Center for Devices
and Radiological Health. 510(k) premarket notification database.
Vacuum assisted closure. K021500. [internet]. Silver Spring
(MD): Food and Drug Administration, Center for Devices and
Radiological Health; 2002 Dec 20 [accessed 2005 Nov 11].
[5 p]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8137. |
√ |
Background |
|
|
|
| (904) |
Guiding principles/documentation behind Prospera
variable pressure therapy (VPT). Fort Worth (TX): Prospera;
1 p.—list of references |
|
|
√ |
List of references |
|
| (905) |
Guiding principles/documentation behind the
use of Lower Pressure Settings. Fort Worth (TX): Prospera;
1 p.—list of references |
|
|
√ |
List of references |
|
| (906) |
Introducing the all-new PRO-II [MR-131-09/08].
Fort Worth (TX): Prospera; 2008. 6 p.—product information |
√ |
Background |
|
|
|
| (543) |
Isago T, Nozaki M, Kikuchi Y, Honda T, Nakazawa
H. Effects of different negative pressures on reduction of
wounds in negative pressure dressings. J Dermatol 2003 Aug;30(8):596-601. |
|
|
√ |
Animal study |
|
| (907) |
Kairinos N, Solomons M, Hudson DA. The paradox
of negative pressure wound therapy - in vitro studies. J
Plast Reconstr Aesthet Surg 2008 Nov 24;Epub ahead of print. |
|
|
√ |
Not a clinical study |
|
| (908) |
Kirby M. Negative pressure wound therapy.
Br J Diabetes Vasc Dis 2007 Sep;7(5):230-4. |
|
|
√ |
Narrative review |
|
| (570) |
Kostiuchenok BM, Kolker II, Karlov VA, Ignatenko
SN, Samykina TD. [The vacuum effect in the surgical treatment
of purulent wounds] translated from Russian. Vestnik Khirurgii
1986;18-21. (Rus). |
|
|
√ |
Not a NPWT device |
|
| (253) |
Krasner DL. Managing wound pain in patients
with vacuum-assisted closure devices. Ostomy Wound Manage
2002 May;48(5):38-43. |
|
|
√ |
Narrative review |
|
| (909) |
Malmsjo M, Ingemansson R, Martin R, Huddleston
E. Negative pressure wound therapy using gauze or polyurethane
open cell foam: similar effects on pressure transduction
and wound contraction. Lund, Sweden: Lund University; 1 p. |
|
|
√ |
Animal study |
|
| (910) |
Miller MS. Commentary: new microvascular blood
flow research challenges practice protocols in negative pressure
wound therapy. Wounds 2005;17(10):290-4. |
|
|
√ |
Narrative review |
|
| (911) |
Molnar JA. The science behind negative pressure
wound therapy. Ostomy Wound Manage 2004 Apr;50(4A Suppl):2-5. |
|
|
√ |
Narrative review |
|
| (33) |
Morykwas MJ, Argenta LC, Shelton-Brown EI,
McGuirt W. Vacuum-assisted closure: a new method for wound
control and treatment: animal studies and basic foundation.
Ann Plast Surg 1997 Jun;38(6):553-62. |
|
|
√ |
Animal study |
|
| (912) |
Motta GJ, Corbett LQ, Milne CT. Impact of
an antimicrobial gauze upon bacterial colonies in wounds
that require packing. 11 p. |
|
|
√ |
Not a NPWT device |
|
| (913) |
NovaSpine LLC. 510(k) summary of safety and
effectiveness. K062456. Rockville (MD): U.S. Food and Drug
Administration; 2006 Sep 27. 5 p. |
√ |
Background |
|
|
|
| (665) |
Philbeck TE Jr, Whittington KT, Millsap MH,
Briones RB, Wight DG, Schroeder WJ. The clinical and cost
effectiveness of externally applied negative pressure wound
therapy in the treatment of wounds in home healthcare Medicare
patients. Ostomy Wound Manage 1999 Nov;45(11):41-50. |
|
|
√ |
Patients treated with dual therapies |
|
| (914) |
Price RD, Nagarajan M, Srinivasan JR. Local
anesthetic for change of vacuum-assisted closure dressings.
Plast Reconstr Surg 2006 Jun;117(7):2537-8. |
|
|
√ |
Letter to the editor |
|
| (915) |
PRO-I [MR-125-04/08]. Fort Worth (TX): Prospera;
2008. 4 p.—product information |
√ |
Background |
|
|
|
| (916) |
Prospera overview [confidential info prepared
for ECRI on behalf of AHRQ]. Forth Worth (TX): Prospera;
2009 Feb. 1 p.—discussion of Prospera approach to
NPWT |
|
|
√ |
Narrative |
|
| (917) |
Rationale for the Choice AMD gauze dressing
system. Fort Worth (TX): Prospera; 2 p.—discussion
of Prospera's reasons for selecting gauze dressings |
|
|
√ |
Narrative |
|
| (918) |
Sargent RL, Mudro P, Mele J, Sons J. The use
of antimicrobial gauze in a home care setting: a cost effective,
proactive wound management plan. 2 p. |
|
|
√ |
Not a NPWT device |
|
| (126) |
Schwien T, Gilbert J, Lang C. Pressure ulcer
prevalence and the role of negative pressure wound therapy
in home health quality outcomes. Ostomy Wound Manag 2005;51:47-60. |
√ |
KQ1, KQ3 |
|
|
|
| (919) |
Shah CB, Swogger E, James G. Efficacy of AMD
dressings against MRSA and VRE. 2006 Jul. 4 p. |
|
|
√ |
Not a NPWT device |
|
| (704) |
Shirakawa M, Isseroff RR. Topical negative
pressure devices: Use for enhancement of healing chronic
wounds. Arch Dermatol 2005 Nov;141(11):1449-53. |
|
|
√ |
Narrative review |
|
| (920) |
Similar physical properties of gauze and polyurethane
foam in delivery of negative pressure wound therapy. St.
Petersburg (FL): Smith & Nephew; 2008. 2 p. |
|
|
√ |
Animal study |
|
| (921) |
Tillery T. The use of a gauze-based dressing
for negative pressure wound therapy (NPWT): clinical and
financial outcomes. 2008. 2 p. |
|
|
√ |
Case study |
|
| (183) |
Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen
H. A systematic review of topical negative pressure therapy
for acute and chronic wounds. Br J Surg 2008 Jun;95(6):685-92. |
√ |
Previous Systematic Reviews |
|
|
|
| (922) |
Usupov YN, Yepifanov MV. [Active wound drainage]
translated from Russian. Vestnik Khirurgii 1987;42-5. (Rus). |
|
|
√ |
Animal study |
|
| (923) |
VPT variable pressure therapy [graph]. Forth
Worth (TX): Prospera; 1 p. |
|
|
√ |
Graph |
|
| (756) |
Wackenfors A, Gustafsson R, Sjogren J, Algotsson
L, Ingemansson R, Malmsjo M. Blood flow responses in the
peristernal thoracic wall during vacuum-assisted closure
therapy. Ann Thorac Surg 2005 May;79(5):1724-30; discussion
1730-. |
|
|
√ |
Animal study |
|
| (40) |
Wackenfors A, Sjogren J, Gustafsson R, Algotsson
L, Ingemansson R, Malmsjo M. Effects of vacuum-assisted closure
therapy on inguinal wound edge microvascular blood flow.
Wound Repair Regen 2004 Nov-Dec;12(6):600-6. |
|
|
√ |
Animal study |
|
| (760) |
Webb LX. New techniques in wound management:
vacuum-assisted wound closure. J Am Acad Orthop Surg 2002
Sep-Oct;10(5):303-11. |
|
|
√ |
Narrative review |
|
| (32) |
Willy C, editor(s). The theory and practice
of vacuum therapy. Scientific basis, indications for use,
case reports, practical advice. Ulm, Germany: Lindqvist book
publishing; 2006. 405 p. |
√ |
Background |
|
|
|
| (767) |
Willy C, Voelker HU, Engelhardt M. Literature
on the subject of vacuum therapy: review and update 2006.
Eur J Trauma Emerg Surg 2007 Feb;33(1):33-9. |
|
|
√ |
Systematic review, but did not evaluate wound
healing outcomes |
|
KQ = Key question
Return to Top
Figure 13 . Disposition of Submission by Smith & Nephew
![Select [D] below for full text description of this figure.](npwtdfig13.gif)
[D] Select for Text Description
Note: Language has been corrected to reflect screening of meeting abstracts, poster presentations and other documents in addition to abstracts and full articles.
Return to Top
Table 54. Status of Submissions
by Smith and Nephew
| Reference Number |
Reference |
Included |
Placement in Report |
Excluded |
Reason for Exclusion |
Included but Not identified
in ECRI Search |
| (924) |
Baffie A, Fromantin L. Clinical case: V1STA.
J Wound Tech 2008 Jun;1:24. |
|
|
√ |
Case study |
|
| (925) |
Beneke MJ, Doner J. Observation of nosocomial
surgical-site infection rates with utilization of antimicrobial
gauze dressing in an acute care setting. Mansfield (MA):
Tyco Healthcare; 2005 Jun. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (926) |
BlueSky Medical Group, Inc. 510(k) summary
for BlueSky VISTA Wound Vacuum System. K061367. Rockville
(MD): U.S. Food and Drug Administration (FDA); 2006 Aug 10.
5 p. |
√ |
Background |
|
|
|
| (927) |
BlueSky Medical Group, Inc. 510(k) summary
for Versatile 1 EZCare Wound Vacuum System. K061919. Rockville
(MD): U.S. Food and Drug Administration (FDA); 2007 Feb 5.
4 p. |
√ |
Background |
|
|
|
| (928) |
Bogart A. The use of antimicrobial gauze dressing
on an infected lower extremity vascular bypass wounds. Mansfield
(MA): Tyco Healthcare; 2005 Oct. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (929) |
Brooks B. (HCPCS Medical Analyst, SADMERC).
Letter regarding the consensus coding decision of SADMERC
and the four durable medical equipment regional carriers
(DMERCs) for Kerlix A.M.D. antimicrobial Large roll and Kerlix
A.M.D. antimicrobial super sponge. 2002 Sep 23. 1 p. |
|
|
√ |
Not part of report |
|
| (930) |
Brown C. (PDAC Medicare Pricing, Data Analysis,
and Coding/Data Analyst, Noridian Administrative Services,
Ltd.). Response to inquiry for coding verification of Renasys
EZ (model # 66800059). Xref 7118176. 2008 Dec 22. 2 p. |
|
|
√ |
Not part of report |
|
| (84) |
Campbell PE, Smith GS, Smith JM. Retrospective
clinical evaluation of gauze-based negative pressure wound
therapy. Int Wound J 2008 Jun;5(2):280-6. |
√ |
KQ3 |
|
|
√ |
| (931) |
Carson R. (Manager, Health Policy & Reimbursement,
North America. Smith & Nephew Wound Management). Additional
evidence for consideration in review of Negative Pressure
Wound Therapy (NPWT). 2009 Feb 5. 3 p; binder of material |
|
|
√ |
Cover letter |
|
| (932) |
Case JM. Microbial challenge test for porous
materials using methylicillin resistant staphylococcus aureus.
Mansfield (MA): Tyco Healthcare; 2001 Jul. 6 p. |
|
|
√ |
Not a NPWT study |
|
| (442) |
Chariker ME, Jeter KF, Tintle TE, Bottsford
JE. Effective management of incisional and cutaneous fistulae
with close suction wound drainage. Contemp Surg 1989 Jun;34:59-63. |
|
|
√ |
Homemade device |
|
| (96) |
Clinical in-market evaluation interim report.
Hull, United Kingdom: Smith & Nephew Medical, Ltd.; 2009
Feb 2. 30 p.
This report provides unpublished data from a
non-comparative study of 132 patients treated with NPWT
systems made by Smith and Nephew. These data were included
under Key Question 3. |
√ |
KQ3 |
|
|
|
| (933) |
Comstock M. Process improvement project: reduction
of surgical site infections utilizing antimicrobial dressings.
Mansfield (MA): Covidien; 2008 Sep. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (934) |
Coutts P, Fierheller M, Broughton C, Sibbald
RG. Effective wound management influences quality of life.
Mansfield (MA): Covidien; 2008 Sep. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (935) |
Davis S, Mertz P, Cazzaniga A, Serralta V,
Orr R, Eaglstein W. The use of a new antimicrobial gauze
dressing: effects on the rate of epithelization of partial
thickness wounds. Mansfield (MA): Tyco Healthcare; 2001 Apr.
4 p. |
|
|
√ |
Not a NPWT study |
|
| (226) |
Eginton MT, Brown KR, Seabrook GR, Towne JB,
Cambria RA. A prospective randomized evaluation of negative-pressure
wound dressings for diabetic foot wounds. Ann Vasc Surg 2003
Nov;17(6):645-9. |
|
|
√ |
Fewer than five patients |
|
| (936) |
EZCARE negative pressure wound therapy. User
guide. Smith & Nephew, Inc.; 31 p. |
√ |
Background |
|
|
|
| (937) |
Fierheller M, Coutts P, Sibbald RG. Holistic
effect of an antimicrobial gauze dressing with Claggett's
Window. Mansfield (MA): Covidien; 2008 Sep. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (938) |
Findley RD, McGaha EC. The successful use
of Negative Pressure Would Therapy after left above the knee
amputation (AKA) revision, in a challenging patient. |
|
|
√ |
Case study |
|
| (499) |
Fleischmann W, Strecker W, Bombelli M, Kinzl
L. [Vacuum sealing as treatment of soft tissue damage in
open fractures]. Unfallchirurgie 1993;96(9):488-92. |
|
|
√ |
Article in German |
|
| (110) |
Ford CN, Reinhard ER, Yeh D, Syrek D, De Las
Morenas A, Bergman SB, Williams S, Hamori CA. Interim analysis
of a prospective, randomized trial of vacuum-assisted closure
versus the Healthpoint system in the management of pressure
ulcers. Ann Plast Surg 2002 Jul;49(1):55-61; discussion 61. |
√ |
KQ1, KQ3 |
|
|
|
| (939) |
Harris R. Analysis of surgical site infection
rates and cost benefits associated with plain gauze dressings
versus gauze dressings impregnated with polyhexamethylene
biguanide (PHMB). Mansfield (MA): Covidien; 4 p. |
|
|
√ |
Not a NPWT study |
|
| (940) |
Hoover J, Kent DJ. Polyhexamethylene biguanide
(PHMB) impregnated gauze for use in treating a gunshot wound.
Mansfiled (MA): Covidien; 2008 Sep. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (941) |
Howe T, Graham R. The successful management
and wound closure of a challenging patient with necrotizing
fasciitis with enteric fistula using negative pressure wound
therapy. |
|
|
√ |
Case study |
|
| (942) |
Hutton CL. The use of antimicrobial gauze
packing in an infected coronary artery bypass graft surgical
incision. Mansfield (MA): Tyco Healthcare; 2005 Jun. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (39) |
Ichioka S, Watanabe H, Sekiya N, Shibata M,
Nakatsuka T. A technique to visualize wound bed microcirculation
and the acute effect of negative pressure. Wound Repair Regen
2008;16:460-5. |
|
|
√ |
Animal study |
|
| (943) |
Jonjo SF. Length of stay: reducing a "weighty" problem
in wound care saving time and improving outcomes. Mansfield
(MA): Tyco Healthcare; 2007 Apr. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (113) |
Joseph E, Hamori CA, Bergman S, et al. A prospective
randomized trial of vacuum-assisted closure versus standard
therapy of chronic nonhealing wounds. Wounds 2002;12(3):60-7. |
√ |
KQ1, KQ3 |
|
|
|
| (907) |
Kairinos N, Solomons M, Hudson DA. The paradox
of negative pressure wound therapy - in vitro studies. J
Plast Reconstr Aesthet Surg 2008 Nov 24;: Epub ahead of print. |
|
|
√ |
In vitro study |
|
| (944) |
LCD for negative pressure wound therapy pumps
(L11489). Baltimore (MD): Centers for Medicare and Medicaid
Services (CMS); 10 p. |
|
|
√ |
Not part of report |
|
| (945) |
LCD for negative pressure wound therapy pumps
(L11500). Baltimore (MD): Centers for Medicare and Medicaid
Services (CMS); 10 p. |
|
|
√ |
Not part of report |
|
| (946) |
LCD for negative pressure wound therapy pumps
(L27025). Baltimore (MD): Centers for Medicare & Medicaid
Services; 10 p. |
|
|
√ |
Not part of report |
|
| (947) |
LCD for negative pressure wound therapy pumps
(L5008). Baltimore (MD): Centers for Medicare & Medicaid
Services; 11 p. |
|
|
√ |
Not part of report |
|
| (259) |
Llanos S, Danilla S, Barraza C, Armijo E,
Pineros JL, Quintas M, Searle S, Calderon W. Effectiveness
of negative pressure closure in the integration of split
thickness skin grafts: a randomized, double-masked, controlled
trial. Ann Surg 2006 Nov;244(5):700-5. |
|
|
√ |
Homemade device |
|
| (948) |
Lovelace L. Antimicrobial dressing intervention
associated with reduction in surgical site infection rate.
Mansfield (MA): Tyco Healthcare; 2008 Jun. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (949) |
Material safety data sheet for DeRoyal Solidifier,
MSDS-002. Product numbers 71-1200, 71-1500, 71-2500, 71-3000,
71-9000, 71-18000, 71 0500, 71-1000. Powell (TN): DeRoyal
Industries, Inc.; 2005 Dec 9. 2 p. |
|
|
√ |
Not part of report |
|
| (950) |
Material safety data sheet for Flexible polyurethane
foam. CAS # 9009-54-5. 2008. 4 p. |
|
|
√ |
Not part of report |
|
| (951) |
Material safety data sheet for Kerlix AMD
super sponges, Kerlix AMD rolls, Excilon AMD sponges, Telfa
AMD sponges. Product numbers 6662, 6665, 6660, 3331, 3332,
7088, 7089, 7662, 7663, 7665, 7666, 7667, 7668. Mansfield
(MA): Tyco Healthcare/Kendall; 2004 May 14. 6 p. |
|
|
√ |
Not part of report |
|
| (952) |
Material safety data sheet for Medical Adhesive
Tape Technologies, product # 09-9000 blue tape. St. Hubert,
Quebec: Medical Adhesive Tape Technologies; 2008 Sep 3. 2
p. |
|
|
√ |
Not part of report |
|
| (953) |
Material safety data sheet for negative pressure
non-adherent gauze. Toronto (ON): Derma Sciences, Inc.; 2008
May 2. 4 p. |
|
|
√ |
Not part of report |
|
| (954) |
Material safety data sheet for Skin Prep Wipes.
Largo (FL): Smith & Nephew, Inc.; 2003 Dec 8. 3 p. |
|
|
√ |
Not part of report |
|
| (955) |
Material safety data sheet for sodium chloride
solution, 0.85% MSDS. Catalog code: SLS2752. Houston (TX):
Sciencelab.com, Inc.; 2008 Nov 6. 6 p. |
|
|
√ |
Not part of report |
|
| (956) |
Material safety data sheet for Styrene-acrylonitrile
copolymer (SAN). CAS registry number: 9003-54-7. IRPC Public
Company Limited; 2006 Dec. 4 p. |
|
|
√ |
Not part of report |
|
| (142) |
McCord SS, Naik-Mathuria BJ, Murphy KM, McLane
KM, Gay AN, Bob Basu C, Downey CR, Hollier LH, Olutoye OO.
Negative pressure therapy is effective to manage a variety
of wounds in infants and children. Wound Repair Regen 2007
May-Jun;15(3):296-301. |
√ |
KQ3 |
|
|
|
| (957) |
McCullin C. The use of an antimicrobial dressing
to help improve outcomes for patients with pressure ulcers
in a skilled nursing facility. Mansfield (MA): Tyco Healthcare;
2005 Oct. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (958) |
McKendrick C. Impact on surgical dressings
on coronary artery bypass graft surgery with resultant influence
on patient safety. Mansfield (MA): Covidien; 2008. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (606) |
McNulty AK, Schmidt M, Feeley T, Kieswetter
K. Effects of negative pressure wound therapy on fibroblast
viability, chemotactic signaling, and proliferation in a
provisional wound (fibrin) matrix. Wound Repair Regen 2007
Nov-Dec;15(6):838-46. |
|
|
√ |
In vitro study |
|
| (959) |
Mertz P, Cazzaniga A, Serralta V, Davis S,
Orr R, Eaglstein W. The effect of an antimicrobial gauze
dressing impregnated with 0.2% polyhexamethylene biguanide
(PHMB) as a barrier to prevent pseudomonas aeruginosa wound
invasion. Mansfield (MA): Tyco Healthcare; 2000 May. 7 p. |
|
|
√ |
Not a NPWT study |
|
| (960) |
Morehouse T, Hager J. Drainage management
of enterocutaneous fistula within an abdominal wound. |
|
|
√ |
Case study |
|
| (33) |
Morykwas MJ, Argenta LC, Shelton-Brown EI,
McGuirt W. Vacuum-assisted closure: a new method for wound
control and treatment: animal studies and basic foundation.
Ann Plast Surg 1997 Jun;38(6):553-62. |
|
|
√ |
Animal study |
|
| (626) |
Morykwas MJ, David LR, Schneider AM, Whang
C, Jennings DA, Canty C, Parker D, White WL, Argenta LC.
Use of subatmospheric pressure to prevent progression of
partial-thickness burns in a swine model. J Burn Care Rehabil
1999 Jan-Feb;20(1 Pt 1):15-21. |
|
|
√ |
Animal study |
|
| (36) |
Morykwas MJ, Faler BJ, Pearce DJ, Argenta
LC. Effects of varying levels of subatmospheric pressure
on the rate of granulation tissue formation in experimental
wounds in swine. Ann Plast Surg 2001 Nov;47(5):547-51. |
|
|
√ |
Animal study |
|
| (961) |
Motta GJ, Trigilia D. Impact of antimicrobial
drain sponge dressing upon specific bacterial isolates at
tracheostomy sites. Mansfield (MA): Tyco Healthcare; 2003
May. 8 p. |
|
|
√ |
Not a NPWT study |
|
| (38) |
Moues CM, Vos MC, van den Bemd GJ, Stijnen
T, Hovius SE. Bacterial load in relation to vacuum-assisted
closure wound therapy: a prospective randomized trial. Wound
Repair Regen 2004 Jan-Feb;12(1):11-7. |
|
|
√ |
Duplicate study (136) |
|
| (962) |
Mullaney B, Lane C. Antimicrobial efficacy
by elution of gauze using methycillin resistant staphlococcus
aureus (MRSA). Mansfield (MA): Tyco Healthcare; 2001 Jul.
4 p. |
|
|
√ |
Not a NPWT study |
|
| (963) |
Mullaney B, Lane C. Antimicrobial efficacy
by elution of gauze using vancomycin resistant enterococcus
faecalis. Mansfield (MA): Tyco Healthcare; 2001 Jul. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (964) |
Neitzel PJ. Reduction of SSIs during a one
year study of CABG procedures in a 393-bed acute care community
hospital. Mansfield (MA): Tyco Healthcare; 2007 Jun. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (646) |
- NPWT Info and history of NPWT. St. Petersburg (FL):
Smith & Nephew, Inc.; 2009 Feb. 13 p.
- Review of the history, mode of action, mechanism of action,
level of negative pressure, context between vacuum source
and clinical outcomes, and clinical evidence relating to
the use of V1STA and EZCARE NPWT systems.
|
√ |
Relevant clinical evidence (96)
included in KQ3 |
|
|
|
| (965) |
O'Brien JA, Broderick GB, Lalikos JF, Ignotz
R, Strom H, Dunn RM. Negative pressure wound therapy as dressing
for split-thickness skin grafts: our experience. 2 p. |
|
|
√ |
Abstract only |
|
| (966) |
Orr R, Eggleston T, Shelanski MV. Determination
of the irritating and sensitizing propensities of Kerlix
A.M.D. antimicrobial gauze dressing on scarified human skin.
Mansfield (MA): Tyco Healthcare; 2003 Jan. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (967) |
Orr R. In vitro efficacy of Kerlix A.M.D.
gauze when used with a primary dressing. Mansfield (MA):
Tyco Healthcare; 2001 Nov. 1 p. |
|
|
√ |
Not a NPWT study |
|
| (968) |
PDAC Medicare pricing, data analysis and coding
for EZCARE system. Model 66800187. [Internet]. Fargo (ND):
Noridian Adminstrative Services, Ltd.; 2008 [accessed 2009
Feb 4]. [1 p]. Available: https://www.dmepdac.com/dmecsapp/do/productdetail?hcpcs_product_id=18187. |
|
|
√ |
Not part of report |
|
| (969) |
PDAC Medicare pricing, data analysis and codinng
for VERSATILE 1 model number: 100.010. [internet]. Fargo
(ND): Noridian Administrative Services, Ltd.; 2008 [accessed
2009 Feb 4]. [1 p]. Available: http://www.dmepdac.com/dmecsapp/do/productdetail?hcpcs_product_id=8929. |
|
|
√ |
Not part of report |
|
| (970) |
Penn RG, Vyhlidal SK, Roberts S, Miller S.
The reduction of vascular surgical site infections with the
use of antimicrobial gauze dressing. Mansfield (MA): Tyco
Healthcare; 2 p. |
|
|
√ |
Not a NPWT study |
|
| (971) |
Product data sheet for PerfecForm 35858-W,
Ionomer-based thermoforming film. Perfecseal, a Bemis Company;
2005 Dec 14. 2 p. |
|
|
√ |
Not part of report |
|
| (972) |
Published pricing for EZCare, V1STA, RENASYS-EZ,
RENASYS-F, Supply kits. 2009 Jan 1. 1 p. |
|
|
√ |
Not part of report |
|
| (55) |
Reitsma AM, Rodeheaver GT. Effectiveness of
a new antimicrobial gauze dressing as a bacterial barrier.
Mansfield (MA): Tyco Healthcare; 2001 Sep. 4 p. |
|
|
√ |
Not a NPWT study |
|
| (973) |
RENASYS EZ negative pressure wound therapy.
Smith & Nephew, Inc.; 22 p. |
√ |
Background |
|
|
|
| (974) |
Russell F. The use of V1STA in open abdominal
wounds and to facilitate fistulae management. 3 p. |
|
|
√ |
Case study |
|
| (34) |
Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber
D, Orgill DP. Vacuum-assisted closure: microdeformations
of wounds and cell proliferation. Plast Reconstr Surg 2004
Oct;114(5):1086-96; discussion 1097-. |
|
|
√ |
Not a clinical study |
|
| (35) |
Scherer SS, Pietramaggiori G, Mathews JC,
Prsa MJ, Huang S, Orgill DP. The mechanism of action of the
vacuum-assisted closure device. Plast Reconstr Surg 2008
Sep;122(3):786-97. |
|
|
√ |
Animal study |
|
| (975) |
Shah CB. Comparison of efficacy and safety
of a new antimicrobial packing strip with PHMB to the current
industry standard iodoform and plan packing strips. Mansfield
(MA): Tyco Healthcare; 3 p. |
|
|
√ |
Not a NPWT study |
|
| (976) |
Shah CB. Testing of antimicrobial efficacy
of wound dressing by in vitro elution model. Mansfield (MA):
Tyco Healthcare; 4 p. |
|
|
√ |
Not a NPWT study |
|
| (977) |
Smith & Nephew labeling information. Smith & Nephew,
Inc.; 33 p. |
|
|
√ |
Not part of report |
|
| (978) |
Smith & Nephew, Inc. 510(k) premarket
notification of intenet to market Renasys-F NPWT foam dressing
kits. K082211. Rockville (MD): U.S. Food and Drug Administration
(FDA); 2008 Nov 14. 2 p. |
√ |
Background |
|
|
|
| (979) |
Smith & Nephew, Inc. 510(k) premarket
notification of intent to market RENASYS EZ. K082426. Rockville
(MD): U.S. Food and Drug Administration (FDA); 2008 Sep 5.
3 p. |
√ |
Background |
|
|
|
| (980) |
Sutterfield R. Resolution of araplegic pressure
ulcer within a challenging home setting. |
|
|
√ |
Not a NPWT study |
|
| (981) |
V1STA negative pressure wound therapy. User
guide. Smith & Nephew, Inc.; 33 p. |
√ |
Background |
|
|
|
| (40) |
Wackenfors A, Sjogren J, Gustafsson R, Algotsson
L, Ingemansson R, Malmsjo M. Effects of vacuum-assisted closure
therapy on inguinal wound edge microvascular blood flow.
Wound Repair Regen 2004 Nov-Dec;12(6):600-6. |
|
|
√ |
Animal study |
|
| (37) |
Weed T, Ratliff C, Drake DB. Quantifying bacterial
bioburden during negative pressure wound therapy: does the
wound VAC enhance bacterial clearance. Ann Plast Surg 2004
Mar;52(3):276-9; discussion 279-80. |
√ |
KQ3 |
|
|
|
| (982) |
Werthen M, Davoudi M, Sonesson A, Nitsche
P, Morgelin M, Blom K, Schmidtchen A. Pseudomonas aeruginosa-induced
infection and degradation of human wound fluid and skin proteins
ex vivo are eradicated by a synthetic cationic polymer. J
Antimicrob Chemother 2004;54(4):772-9. |
|
|
√ |
Not a NPWT study |
|
| (983) |
Zanotti EA, Rosenbloom RD. Use of negative
pressure wound therapy over matrix regeneration grafts. |
|
|
√ |
Case study |
|
KQ = Key question
Return to Top
Figure 14 . Disposition of Submission by Talley Group
Ltd.
![Select [D] below for full text description of this figure.](npwtdfig14.gif)
[D] Select for Text Description
Note: Language has been corrected to reflect screening of meeting abstracts, poster presentations and other documents in addition to abstracts and full articles.
Return to Top
Table 55. Status of Submission
by Talley Group, Ltd.
| Reference Number |
Reference |
Included |
Placement
in Report |
Disposition in Report |
| (984) |
Spruce P. (Clinical Director, TVRE Consulting).
AHRQ submission on behalf of Talley Group, Ltd. 2009 Feb
5. 1 p.
A list of 8 case reports or case series was provided.
The reports were either published as meeting presentations
or available on the company Web site. |
|
|
Case reports were not included in this report.
The case-series studies did not report outcomes of interest
to this report |
| (985) |
- Submission of clinical evidence for the VENTURI negative
pressure wound therapy system. United Kingdom: Talley
Group, Ltd.; 2009. 31 p.
- An outline of studies, primarily case reports but also
animal and in vitro studies, was provided.
|
|
|
Case reports were not included in this report.
The case-series studies did not report outcomes of interest
to this report.
Animal and in vitro studies were not considered in this
report |
| (986) |
Venturi advanced vacuum system for negative
pressure wound therapy. United Kingdom: Talley Group, Ltd.;
2 p.—product brochure |
√ |
Background |
|
Current as of June 2009
Internet Citation:
Negative Pressure Wound Therapy. Technology Assessment. June 2009. Rockville, MD: Agency for Healthcare Research and Quality. http://www.ahrq.gov/clinic/ta/negpresswtd/
|
540 Gaither Road Rockville, MD 20850 