Appendix D: Tables 45-55

Negative Pressure Wound Therapy Devices

Technology assessment on negative pressure wound therapy devices.

On this page:

Figure 8 . Disposition of Submission by CMS

 Select [D] below for full text description of this figure.

[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 45. Status of CMS submission: Publications

Reference NumberReferenceIncludedPlacement in ReportExcludedReason for ExclusionIncluded 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

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Table 46. Status of CMS submission: Government Documents

Reference NumberReferenceDisposition 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

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Table 47. Status of CMS submission: Miscellaneous Material

Reference NumberReferenceDisposition 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 brochureUsed 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 brochureUsed 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 brochureUsed as background information
(829)Lewis P. Smith & Nephews acquires BlueSky medical group. Remington Rep 2007; news releaseNot 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 brochureUsed 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 reportNot used in this report
 V.A.C. Annotated Peer-reviewed Article Bibliography prepared by KCIWe 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 brochureUsed as background information

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Table 48. Status of CMS submission: Material from KCI or related to KCI

Reference NumberReferenceDisposition in Report
(833)Cynthia S. Hake. CMS meeting with KCI. 2005. 68 p. KCI presentation to CMS comparing V.A.C. to BlueSky Versatile 1Not 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 V1Not 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 CatalogNot 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 CMSNot used in
this report
(942)Moton T. (Briefing Coordinator). Meeting with Kinetic Concepts Incorporated (KCL). 2006. 30 p. KCI presentation to CMSNot 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 CMSNot 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

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Table 49. Status of CMS submission: Material from BlueSky or related to BlueSky

Reference NumberReferenceDisposition
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 CMSNot 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 MedicalNot 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 lawsuitNot 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

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 Figure 9. Disposition of Submission by ConvaTec

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Table 50. Status of Submission by ConvaTec

Reference NumberReferenceIncludedPlacement in ReportDisposition 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

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 Figure 10. Disposition of Submission by Individuals

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Table 51. Status of Submission by Individuals

Reference NumberReferenceIncludedPlacement in ReportExcludedReason for ExclusionIncluded 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 

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Figure 11 . Disposition of Submission by Medela, Inc.

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Table 52. Status of Submission by Medela

Reference NumberReferenceIncludedExcludedReason 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

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Figure 12 . Disposition of Submission by Prospera

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Table 53. Status of Submissions by Prospera

Reference NumberReferenceIncludedPlacement in ReportExcludedReason for ExclusionIncluded 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 informationBackground   
(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 informationBackground   
(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

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Figure 13 . Disposition of Submission by Smith & Nephew

 

Select [D] below for full text description of this figure. [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.

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Table 54. Status of Submissions by Smith and Nephew

Reference NumberReferenceIncludedPlacement in ReportExcludedReason for ExclusionIncluded 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

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Figure 14 . Disposition of Submission by Talley Group Ltd.

Select [D] below for full text description of this figure.

[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.

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Table 55. Status of Submission by Talley Group, Ltd.

Reference NumberReferenceIncludedPlacement
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 brochureBackground 

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Current as of November 2009
Internet Citation: Appendix D: Tables 45-55: Negative Pressure Wound Therapy Devices. November 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/appendix-dt45-55.html