Appendix A

Technology assessment on negative pressure wound therapy devices.

Methods of Identifying the Literature

Electronic Database Searches
Topic-specific Search Terms
EMBASE/MEDLINE: Human, English Language
PubMed: English Language, In Process/Publisher

Table 18. Excluded Studies
Table 19. Summary of Stakeholder Solicitations and Responses
Table 19a. Total Stakeholder Solicitations and Responses

Electronic Database Searches

The following databases have been searched for relevant information:

NameDate LimitsPlatform/Provider
CINAHL (Cumulative Index to Nursing and Allied Health Literature)1982 through January 19, 2009OVID
ClinicalTrials.govSearched December 24, 2008www.clinicaltrials.gov
The Cochrane Central Register of Controlled Trials (CENTRAL)Through 2009, Issue 1www.thecochranelibrary.com
The Cochrane Database of Systematic Reviews (Cochrane Reviews)Through 2009, Issue 1www.thecochranelibrary.com
Current Controlled TrialsSearched February 24, 2009http://www.controlled-trials.com/mrct/
Database of Abstracts of Reviews of Effects (DARE)Through 2009, Issue 1www.thecochranelibrary.com
EMBASE (Excerpta Medica)1980 through March 23, 2009OVID
FDA MAUDE Database1999-February 28, 2009http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfMAUDE/search.CFM
Health Technology Assessment Database (HTA)Through 2009, Issue 1www.thecochranelibrary.com
Healthcare StandardsSearched January 30, 2009ECRI Institute
MEDLINE1950 through March 23, 2009OVID
PreMEDLINESearched January 7, 2009www.pubmed.gov
U.K. National Health Service Economic Evaluation Database (NHS EED)Through 2009, Issue 1www.thecochranelibrary.com
U.S. Centers for Medicare & Medicaid (CMS) Web siteSearched December 24, 2008www.cms.gov
www.coverageandpayment.com
U.S. National Guideline Clearinghouse™ (NGC)Searched January 30, 2009www.ngc.gov

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Hand Searches of Journal and Nonjournal Literature

Journals and supplements maintained in ECRI's collections were routinely reviewed. Nonjournal publications and conference proceedings from professional organizations, private agencies, and government agencies were also screened. Other mechanisms used to retrieve additional relevant information included review of bibliographies/reference lists from peer-reviewed and gray literature. (Gray literature consists of reports, studies, articles, and monographs produced by federal and local government agencies, private organizations, educational facilities, consulting firms, and corporations. These documents do not appear in the peer-reviewed journal literature.)

Search Strategies

The search strategies employed combinations of freetext keywords as well as controlled vocabulary terms including (but not limited to) the following concepts. The strategy below is presented in OVID syntax; the search was simultaneously conducted across Embase, Medline, and PsycINFO. A parallel strategy was used to search the databases comprising the Cochrane Library.

Medical Subject Headings (MeSH), Emtree, PsycINFO and Keywords

Conventions:

OVID

$          =    truncation character (wildcard)
exp       =    “explodes” controlled vocabulary term (e..g., expands search to all more specific related terms in the vocabulary’s hierarchy)
.de.       =    limit controlled vocabulary heading
.fs.       =    floating subheading
.hw.      =    limit to heading word
.md.     =    type of methodology (PsycINFO)
.mp.     =    combined search fields (default if no fields are specified)
.pt.       =    publication type
.ti.        =    limit to title
.tw.      =    limit to title and abstract fields

PubMed

[mh]     =    MeSH heading
[majr]   =    MeSH heading designated as major topic
[pt]       =    publication type
[sb]      =    Subset of PubMed database (PreMedline, Systematic, OldMedline)
[sh]      =    MeSH subheading (qualifiers used in conjunction with MeSH headings)
[tiab]    =    keyword in title or abstract
[tw]      =    text word

Topic-specific Search Terms

ConceptControlled VocabularyKeywords
Negative pressure wound therapy

Vacuum assisted closure
Vacuum

Negative pressure wound therapy (CINAHL heading only)

NPWT
Negative pressure
Negative-pressure
Subatmospheric
Sub-atmospheric
VAC
V.A.C.
VACT
V.A.C.T.
Vacuum assisted
Vacuum-assisted
Specific Devices Active AC
Exsudex
Ezcare system
Invia
Liberty
Mini VAC
Model 2006
npd 1000
Prospera
Svedman treatment unit
VAC freedom
Venturi negative pressure
Versatile 1
Vista portable
Wound therapy pump
Specific Manufacturers Blue Sky
BlueSky
Iasis
Innovative Therapies
Kalypto
KCI
Kinetic Concepts
Medela
Prospera
Superior Healthcare
Talley Medical
WoundsDiabetic foot
Exp injury/
Exp plastic surgery/
Exp reconstructive surgical procedures/
Exp skin ulcer/
Exp skin ulcers/
Surgical flaps
Exp wounds and injuries/
Wound$
Exp wound healing/


 
Amputate$
Bed sore$
Burn$
Decubitus
Deglov$
Dehisc$
Diabetic sore$
Diabetic ulcer$
Electric$ injur$
flap
Frostbit$
Pressure sore$
Pressure ulcer$

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EMBASE/MEDLINE: Human, English Language

Set NumberConceptSearch Statement
1NPWTVacuum assisted closure.de. or vacuum.de. or (negative-pressure or negative pressure or NPWT or vacuum assisted or vacuum-assisted or VAC or VACT or subatmospheric or sub-atmospheric)
2Specific devicesActive ac or Exusdex or Ezcare system or Invia or liberty or Mini VAC or Model 2006 or npd 1000 or prospera or Svedman treatment unit or VAC freedom or Venturi negative pressure or Versatile 1 or Vista portable or Wound therapy pump
3Specific manufacturers(Blue Sky or BlueSky or Iasis or Innovative Therapies or Kalypto or KCI or Kinetic Concepts or Medela or Prospera or Superior healthcare or Talley Medical).dm,ti,ab.
4Combine setsor/1-3
5Wounds & wound healingExp wounds and injuries/ or exp injury/ or exp wound healing/ or wound$.hw. or exp reconstructive surgical procedures/ or exp plastic surgery/ or su.fs.
6Specific woundsSurgical flaps.de. or Exp skin ulcers/ or exp skin ulcer/ or decubitus or ((bed or pressure or diabet$) adj (sore$ or ulcer$)) or bedsore$ or diabetic foot.de.
7 Amputat$ or Burn$ or Deglov$ or Electric$ injur$ or Frostbit$ or Wound$ or flap or dehisc$
8Combine setsor/5-7
9Combine sets4 and 8
10Limit by publication type9 not ((letter or editorial or news or comment or case reports or note or conference paper).de. or (letter or editorial or news or comment or case reports).pt.)
11Limit by study type10 and ((cross-over studies or crossover procedure or crossover design or exp controlled study/ or exp clinical trial/ or exp comparative study/ or cohort analysis or intermethod comparison or parallel design or control group or prospective study or retrospective study or case control study or major clinical study).de. or (ISRTCN or “0400 empirical study” or “0430 followup study” or “0450 longitudinal study” or “0451 prospective study” or “0600 field study” or prospect$).tw.)
12Eliminate overlapRemove duplicates from 11

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PubMed: English Language, In Process/Publisher

Set NumberConceptSearch Statement
1NPWT“negative-pressure” OR “negative pressure” OR NPWT OR “vacuum assisted” OR “vacuum-assisted” OR VAC OR “V.A.C.” OR VACT OR “V.A.C.T.” OR subatmospheric OR “sub-atmospheric”
2Specific devices“Active ac” OR Exusdex OR “Ezcare system” OR Invia OR liberty OR “Mini V.A.C.” OR “mini-V.A.C.” OR “Model 2006” OR “npd 1000” OR prospera OR “Svedman treatment unit” OR “VAC freedom” OR “Venturi negative pressure” OR “Versatile 1” OR “Vista portable” OR “Wound therapy pump”
3Specific manufacturers“Blue Sky” OR BlueSky OR Iasis OR “Innovative Therapies” OR Kalypto OR KCI OR “Kinetic Concepts” OR Medela OR Prospera OR “Superior healthcare” OR “Talley Medical”
4Combine setsor/1-3
5Wound healingWound* OR injury OR injuries OR heal OR healed OR healing
6 ((bed OR pressure OR diabetic) AND (sore* OR ulcer*)) OR bedsore* OR “diabetic foot”
7 Amputat$ OR Deglov$ or Electric$ OR fracture* OR Frostbit$ or burn$ OR flap OR dehisc$ OR surgical
8Combine sets#5 OR #6 OR #7
 
Total IdentifiedTotal DownloadedTotal RetrievedTotal Included
1,078382288137

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Table 13. Excluded Documents

ReferenceReason for Exclusion
Agosti et al. 2007(191)Case study
Apelqvist et al. 2008(192)Cost analysis
Armstrong and Nguyen 2000(193)Not a NPWT device
Armstrong et al. 2004(194)*Possibly a homemade device
Armstrong et al. 2005(195)Duplicate study(109)
Armstrong et al. 2006(196)Conference presentation
Augustin 2006(197)Conference abstract
Aust et al. 2008(198)No relevant outcomes
Baharestani et al. 2008(199)No relevant outcomes
Barker et al. 2000(200)Not a commercially available device
Barnes and Miller 2007(201)Conference abstract
Barringer et al. 2004(202)Not a clinical study
Bee et al. 2008(203)Subpopulation received both treatments
Bernstein et al. 2008(204)Conference abstract
Bischoff et al. 2003(205)Homemade device
Blackett and Bohnenkamp 2006(206)Conference presentation
Bovill et al. 2008(207)Narrative
Brin et al. 2006(208)Case report
Bruenner et al. 2006(209)Conference abstract
Bui et al. 2006(210)Homemade device
Burbage 2008(211)Conference presentation
Burdette-Taylor 2003(212)Case reports
Buttenschoen et al. 2001(213)Homemade device
Campbell 2004(214)Case report
Centers for Medicare & Medicaid Services 2009(215)HCPCS and CPT coding information
Centers for Medicare & Medicaid Services 2009(216)HCPCS and CPT coding information
Centers for Medicare & Medicaid Services 2009(217)DMEPOS fee schedule
Chavarria-Aguilar et al. 2004(218)Homemade device
Cipolla et al. 2005(219)Does not address key question
Corvino and Stokes 2008(220)Case report
Davis 2006(221)Case report
Dedmond et al. 2006(222)Duplicate study(27)
De Leon et al. 2006(223)Conference presentation
Doxford 2007(224)Narrative
Edwards 2006(225)Conference abstract
Eginton et al. 2003(226)Fewer than 5 patients per study arm
Eifert et al. 2007(227)Patients received dual therapies
Excerpt from Teot et al. 2008(228)Duplicate study(229)
Farren et al. 2007(230)Case study
Fife et al. 2008(231)No relevant outcomes
Foo et al. 2008(232)Case report
Francu 2008(233)Conference abstract
Frykberg et al. 2006(234)Guideline
Girolami et al. 2007(235)Case reports
Gupta et Cho 2004(236)Duplicate study(188)
Harris 2007(237)Case study
Harris 2008(238)Case report
Heinsler et al. 2006(239)Conference presentation
Hill et al. 2007(240)Case reports
Howell-Taylor et al. 2008(241)Case reports
Hunter et al. 2007(242)Narrative
Ingari et Powell 2007(26)Narrative
Institute for Clinical Systems Improvement 2008(243)Health Care Protocol
IQWiG 2006(244)Duplicate study(173)
IQWiG 2007(245)Narrative
Jeschke et al. 2004(246)Dual therapy
Jones et al. 2005(247)Healthy volunteers
Karoo et al. 2008(248)Case report
Kendall et al. 2008(249)Conference presentation
Keyser 2008(250)Conference presentation
Kim et Hong 2007(251)Homemade device
Kollrack and Mollenhoff 2008(252)Conference abstract
Krasner D. 2002(253)Does not address key question
Kring et al. 2008(254)Case reports
Kwansink et al. 2005(255)Does not address key question
Lambert et al. 2005(256)Narrative
Lang et al. 1999(159)*Possibly a homemade device
Lavery et al. 2008(257)Duplicate study(257)
Li et al. 2007(258)Not a NPWT study
Lianos et al. 2006(259)Homemade device
Lopez et al. 2005(260)Homemade device
Lubke et al. 2008(261)Conference abstract
Luckraz et al. 2003(262)Patients received dual therapies
Manahan and Shermak 2006(263)Does not address key question
Martinsek et al. 2007(264)Case report
Matzi et al. 2006(265)Conference abstract
McCord et al. 2007(266)Conference presentation
McGinnis and Lisco 2007(267)Case report
McLane et al. 2006(268)Case report
Medeiros et al. 2004(269)Not a NPWT study
Mees et al. 2008(270)Homemade device
Mendez-Eastman S. 2005(271)Does not address key question
Miller and Brown 2003(272)Case report
Miller and Brown 2003(273)Case report
Miller and Brown 2003(274)Case report
Miller and Brown 2004(275)Case report
Miller and McDaniel 2004(276)Case reports
Miller and McDaniel 2005(277)Case report
Miller and McDaniel 2005(278)Case report
Miller and McDaniel 2005(279)Case report
Miller and McDaniel 2006(280)Case reports
Miller et al. 2002(281)Study arms both received V.A.C.®
Miller et al. 2004(282)Study arms both received V.A.C.®
Miller et al. 2005(283)Case report
Mody et al. 2008(284)Homemade device
Moues et al. 2004(38)Duplicate study(136)
Moues et al. 2005(285)Duplicate study(38)
Nelson 2007(286)Narrative
NHS Quality Improvement Scotland 2003(287)Narrative
Niehuser 2008(288)Case report
No author 2008(289)Conference abstract
No author 2008(290)Conference abstract
Noridian 2008(291)HCPCS coding information
O’Keefe and Gutta 2008(292)Conference abstract
Olejnik et al. 2008(293)Homemade device
Oomen et al. 2007(294)Focus on reconstructive surgery
Parker et al. 2007(295)Not a NPWT study
Parrett et al. 2006(296)Narrative
Pattison et al. 2006(297)Case report
Peinemann et al. 2008(298)Methodology paper
Powell and Bruch 2007(299)Case report
Price et al. 2006(300)Conference abstract
Pu 2008(301)Narrative
Rajzer et al. 2006(302)Conference abstract
Reddy et al. 2008(303)Focus too broad for inclusion as Previous Systematic Review
Registered Nurses Association of Ontario 2005(304)Guideline
Registered Nurses Association of Ontario 2007(305)Guideline
Sachithanandan et al. 2008(306)No relevant outcomes
Schimmer 2007(307)Does not address key question
Schlatterer et al. 2008(308)Narrative
Schuster et al. 2006(309)Focus on acellular dermal matrix
Segers et al. 2006(310)Uses KCI foam dressing only
Segers et al. 2006(311)Does not address key question
Sibbald et al. 2003(312)Narrative review
Shalom et al. 2008(313)Homemade device
Simek 2006(314)Conference abstract
Smith 2004(315)Reanalysis of already published data
Sposato et al. 2001(316)Not describing a clinical study
Stojkovic et al. 2008(317)Protocol
Strecker et al. 2007(318)*Possibly a homemade device
Stremitzer et al. 2006(319)Conference abstract
Suess et al. 2006(320)Narrative
Tamir et al. 2006(321)Conference abstract
Tamir et al. 2007(322)Does not address key question
Tanna et al. 2009(323)Case report
Teot et al. 2006(229)*Possibly a homemade device
Teot et al. 2007(324)Conference presentation
Teot et al. 2007(325)Duplicate report(324)
Timmers et al. 2005(326)Healthy volunteers/No relevant outcomes
Timms 2007(327)Case report
TriCenturion 2004(328)Coverage information/pumps
TriCenturion 2006(329)Review of HCPCS E2402
TriCenturion 2007(330)Coverage information/pumps
TriCenturion 2007(331)Review of HCPCS E2402
TriCenturion 2008(332)Review of HCPCS E2402
Wainstein et al. 2008(333)Does not address key question
Webb 2008(334)Conference presentation
Webb 2008(335)Conference presentation
Wild et al. 2004(336)Non-English
Witkowski 2008(337)Conference abstract
World Union of Wound Healing Societies 2008(338)Consensus document

* Study authors did not reply to our request for information

Note: Table 13 has been corrected to reflect the 151 documents excluded at the "article level" (i.e., based on full document, whether a published study, meeting abstract or conference presentation, or other retrieved document) during the review of materials identified in internal electronic and manual searches.

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Table 14. Summary of Stakeholder Solicitations and Responses

NameType of ContactResponses Received (Y/N)
Boehringer Laboratories, Inc./ConvaTec Inc. markets and distributes all Boehringer Laboratory NPWT systemsManufacturerY
Innovative Therapies, Inc.ManufacturerN
Kinetic Concepts, Inc. (KCI)ManufacturerY
Medela Healthcare/Medela, Inc.ManufacturerY
Premco Medical Systems, Inc.ManufacturerN
Prospera TechnologiesManufacturerY
Smith & NephewManufacturerY
Superior Health Care Concepts d/b/a National Wound CareManufacturerN
Talley Medical, USAManufacturerY
MediTop BVVendor Identified by AHRQN
Kalypto MedicalVendor Identified by AHRQN
Advanced Medical Technology Association (AdvaMed)Professional OrganizationN
American Academy of DermatologyProfessional OrganizationN
American Association of Diabetes EducatorsProfessional OrganizationN
American Burn AssociationProfessional OrganizationN
American College of SurgeonsProfessional OrganizationN
American Diabetes AssociationProfessional OrganizationN
American Professional Wound Care AssociationProfessional OrganizationN
American Society of Plastic SurgeonsProfessional OrganizationN
Association for the Advancement of Wound CareProfessional OrganizationY
Biotechnology Industry Organization (BIO)Professional OrganizationN
Medical Device Manufacturers AssociationProfessional OrganizationN
National Pressure Ulcer Advisory Panel (NPUAP)Professional OrganizationN
Wound Care InstituteProfessional OrganizationN
Wound Healing SocietyProfessional OrganizationN
Wound Ostomy and Continence Nurses SocietyProfessional OrganizationY
CMSOtherY
FDAOtherN
K. Kowalske, M.D. (upon AHRQ's request)OtherN

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Table 14a. Total Stakeholder Solicitations and Responses

Type of ContactTotal Number Contacted
by ECRI Institute
Total Number
of Responses
Manufacturers96
Additional vendors identified by AHRQ20
Professional Organizations152
Other: CMS & FDA21
    K. Kowalske, M.D.10
Totals299

Notes:

  1. Initial contact was made on 12/30/08 via e-mail and hard mail. Follow-up e-mails were sent on 01/29/09.
  2. A submission was received from the American Physical Therapy Association; however, this organization was not on the list of those we contacted directly. This response was not included in the table above.
  3. A submission was received from Alliance of Wound Care Stakeholders/Coalition of Wound Care Manufacturers (Nusgart Consulting); however, this organization was not on the list of those we contacted directly. This response was not included in the table above.
  4. This table does not reflect other unsolicited responses received.
Current as of November 2009
Internet Citation: Appendix A. November 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/appendix-a.html