Appendix A
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:
| Name |
Date Limits |
Platform/Provider |
| CINAHL (Cumulative Index to Nursing and Allied
Health Literature) |
1982 through January 19, 2009 |
OVID |
| ClinicalTrials.gov |
Searched December 24, 2008 |
www.clinicaltrials.gov |
| The Cochrane Central Register of Controlled Trials (CENTRAL) |
Through 2009, Issue 1 |
www.thecochranelibrary.com |
| The Cochrane Database of Systematic Reviews
(Cochrane Reviews) |
Through 2009, Issue 1 |
www.thecochranelibrary.com |
| Current Controlled Trials |
Searched February 24, 2009 |
http://www.controlled-trials.com/mrct/ |
| Database of Abstracts of Reviews of Effects
(DARE) |
Through 2009, Issue 1 |
www.thecochranelibrary.com |
| EMBASE (Excerpta Medica) |
1980 through March 23, 2009 |
OVID |
| FDA MAUDE Database |
1999-February 28, 2009 |
http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfMAUDE/search.CFM |
| Health Technology Assessment Database (HTA) |
Through 2009, Issue 1 |
www.thecochranelibrary.com |
| Healthcare Standards |
Searched January 30, 2009 |
ECRI Institute |
| MEDLINE |
1950 through March 23, 2009 |
OVID |
| PreMEDLINE |
Searched January 7, 2009 |
www.pubmed.gov |
| U.K. National Health Service Economic Evaluation
Database (NHS EED) |
Through 2009, Issue 1 |
www.thecochranelibrary.com |
| U.S. Centers for Medicare & Medicaid
(CMS) Web site |
Searched December 24, 2008 |
www.cms.gov
www.coverageandpayment.com |
| U.S. National Guideline Clearinghouse™ (NGC) |
Searched January 30, 2009 |
www.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
| Concept |
Controlled Vocabulary |
Keywords |
| 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 |
| Wounds |
Diabetic 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 Number |
Concept |
Search Statement |
| 1 |
NPWT |
Vacuum 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) |
| 2 |
Specific devices |
Active 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 |
| 3 |
Specific 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. |
| 4 |
Combine sets |
or/1-3 |
| 5 |
Wounds & wound healing |
Exp wounds and injuries/ or exp injury/ or exp wound
healing/ or wound$.hw. or exp reconstructive surgical procedures/
or exp plastic surgery/ or su.fs. |
| 6 |
Specific wounds |
Surgical flaps.de. or Exp skin ulcers/ or exp skin ulcer/
or decubitus or ((bed or pressure or diabet$) 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$ |
| 8 |
Combine sets |
or/5-7 |
| 9 |
Combine sets |
4 and 8 |
| 10 |
Limit by publication type |
9 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.) |
| 11 |
Limit by study type |
10 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$).tw.) |
| 12 |
Eliminate overlap |
Remove duplicates from 11 |
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PubMed: English Language,
In Process/Publisher
| Set Number |
Concept |
Search Statement |
| 1 |
NPWT |
“negative-pressure” OR “negative pressure” OR
NPWT OR “vacuum assisted” OR “vacuum-assisted” OR
VAC OR “V.A.C.” OR VACT OR “V.A.C.T.” OR
subatmospheric OR “sub-atmospheric” |
| 2 |
Specific devices |
“Active ac” OR Exusdex OR “Ezcare system” OR
Invia OR liberty OR “Mini V.A.C.” OR “mini-V.A.C.” OR “Model
2006” OR “npd 1000” OR prospera OR “Svedman
treatment unit” OR “VAC freedom” OR “Venturi
negative pressure” OR “Versatile 1” OR “Vista
portable” OR “Wound therapy pump” |
| 3 |
Specific manufacturers |
“Blue Sky” OR BlueSky OR Iasis OR “Innovative
Therapies” OR Kalypto OR KCI OR “Kinetic Concepts” OR
Medela OR Prospera OR “Superior healthcare” OR “Talley
Medical” |
| 4 |
Combine sets |
or/1-3 |
| 5 |
Wound healing |
Wound* OR injury OR injuries OR heal OR healed OR healing |
| 6 |
|
((bed OR pressure OR diabetic) AND (sore* OR ulcer*))
OR bedsore* OR “diabetic foot” |
| 7 |
|
Amputat$ OR Deglov$ or Electric$ OR fracture* OR Frostbit$
or burn$ OR flap OR dehisc$ OR surgical |
| 8 |
Combine sets |
#5 OR #6 OR #7 |
| Total Identified |
Total Downloaded |
Total Retrieved |
Total Included |
| 1,078 |
382 |
288 |
140 |
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Table 13. Excluded
Studies
| Reference |
Reason for Exclusion |
Level Excluded |
| Apelqvist et al. 2008 (191) |
Cost analysis |
Article |
| Armstrong and Nguyen 2000 (192) |
Not a NPWT device |
Article |
| Armstrong et al. 2004 (193)* |
Homemade device |
Article |
| Armstrong et al. 2005 (194) |
Duplicate study (109) |
Article |
| Aust et al. 2008 (195) |
No relevant outcomes |
Article |
| Australian Safety and Efficacy Register 2003
(196) |
Updated version included (176) |
Abstract |
| Baharestani et al. 2008 (197) |
No relevant outcomes |
Article |
| Barringer et al. 2004 (198) |
Not a clinical study |
Article |
| Bee et al. 2008 (199) |
Subpopulation received both treatments |
Article |
| Benbow et al. 2007 (200) |
Not relevant—focus on access and usage of NPWT |
Abstract |
| Berg et al. 2000 (201) |
Not relevant to topic |
Abstract |
| Bovill et al. 2008 (202) |
Narrative |
Article |
| Bui et al. 2006 (203) |
Homemade device |
Article |
| Buttenschoen et al. 2001 (204) |
Homemade device |
Article |
| Chavarria-Aguilar et al. 2004 (205) |
Homemade device |
Article |
| Cipolla et al. 2005 (206) |
Does not address key question |
Article |
| Dedmond et al. 2006 (207) |
Duplicate study (27) |
Article |
| Doxford 2007 (208) |
Narrative |
Article |
| Edgar et al. 2007 (209) |
Protocol |
Abstract |
| Eginton et al. 2003 (210) |
Fewer than 5 patients per study arm |
Article |
| Excerpt from Teot et al. 2008 (211) |
Duplicate study (212) |
Article |
| Fife et al. 2008 (213) |
No relevant outcomes |
Article |
| Foo et al. 2008 (214) |
Case report |
Article |
| Glenny et al. 2005 (102) |
Not relevant to topic |
Abstract |
| Grahn et al. 2007 (215) |
Narrative |
Abstract |
| Greer et al. 1999 (216) |
Ongoing trial |
Abstract |
| Gupta et Cho 2004 (217) |
Duplicate study (188) |
Article |
| Hemkens et al. 2008 (218) |
Narrative |
Abstract |
| Ingari et Powell 2007 (26) |
Narrative |
Article |
| IQWiG 2006 (219) |
Duplicate study (173) |
Article |
| IQWiG 2007 (220) |
Narrative |
Article |
| Jeschke et al. 2004 (221) |
Dual therapy |
Article |
| Jones et al. 2005 (222) |
Healthy volunteers |
Article |
| Karoo et al. 2008 (223) |
Not relevant to topic |
Article |
| Kim et Hong 2007 (224) |
Homemade device |
Article |
| Krasner D. 2002 (225) |
Does not address key question |
Article |
| Kwansink et al. 2005 (226) |
Does not address key question |
Article |
| Lambert et al. 2005 (227) |
Narrative |
Article |
| Lang et al. 1999 (159)* |
Homemade device |
Article |
| Lavery et al. 2008 (228) |
Duplicate study (228) |
Article |
| Lianos et al. 2006 (229) |
Homemade device |
Article |
| Lopez et al. 2005 (230) |
Homemade device |
Article |
| Luckraz et al. 2003 (231) |
Not relevant to topic |
Article |
| Manahan and Shermak 2006 (232) |
Does not address key questions |
Article |
| Medeiros et al. 2004 (233) |
Not relevant to topic |
Article |
| Mendez-Eastman S. 2005 (234) |
Does not address key question |
Article |
| Miller et al. 2004 (235) |
Study arms both received V.A.C.® |
Article |
| Miller et al. 2002 (236) |
Study arms both received V.A.C.® |
Article |
| Mody et al. 2008 (237) |
Homemade device |
Article |
| Moues et al. 2004 (38) |
Duplicate study (136) |
Article |
| Moues et al. 2005 (238) |
Duplicate study (38) |
Article |
| Nelson 2007 (239) |
Narrative |
Article |
| Olejnik et al. 2008 (240) |
Homemade device |
Article |
| Oomen et al. 2007 (241) |
Not relevant to topic |
Article |
| Parrett et al. 2006 (242) |
Narrative |
Article |
| Peinemann et al. 2008 (243) |
Methodology paper |
Article |
| Pu 2008 (244) |
Narrative |
Article |
| Rapp 2008 (245) |
Narrative |
Abstract |
| Sachithanandan et al. 2008 (246) |
No relevant outcomes |
Article |
| Schimmer 2007 (247) |
Does not address key question |
Article |
| Schlatterer et al. 2008 (248) |
Narrative |
Article |
| Schuster et al. 2006 (249) |
Not relevant to topic |
Article |
| Segers et al. 2006 (250) |
Uses KCI foam dressing only |
Article |
| Segers et al. 2006 (251) |
Does not address key question |
Article |
| Sibbald et al. 2003 (252) |
Narrative review |
Article |
| Shalom et al. 2008 (253) |
Homemade device |
Article |
| Smith 2004 (254) |
Reanalysis of already published data |
Article |
| Sposato et al. 2001 (255) |
Not describing a clinical study |
Article |
| Strecker et al. 2007 (256)* |
Homemade device |
Article |
| Suess et al. 2006 (257) |
Narrative |
Article |
| Tamir et al. 2007 (258) |
Does not address key question |
Article |
| Tanna et al. 2009 (259) |
Case report |
Article |
| Teot et al. 2006 (212)* |
Homemade device |
Article |
| Timmers et al. 2005 (260) |
Healthy volunteers/No relevant outcomes |
Article |
| Wainstein et al. 2008 (261) |
Does not address key question |
Article |
| Wild et al. 2004 (262) |
Non-English |
Article |
*
Study authors
did not reply to our request for information
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Table 14. Summary of
Stakeholder Solicitations and Responses
| Name |
Type of Contact |
Responses Received (Y/N) |
| Boehringer Laboratories, Inc./ConvaTec Inc.
markets and distributes all Boehringer Laboratory NPWT
systems |
Manufacturer |
Y |
| Innovative Therapies, Inc. |
Manufacturer |
N |
| Kinetic Concepts, Inc. (KCI) |
Manufacturer |
Y |
| Medela Healthcare/Medela, Inc. |
Manufacturer |
Y |
| Premco Medical Systems, Inc. |
Manufacturer |
N |
| Prospera Technologies |
Manufacturer |
Y |
| Smith & Nephew |
Manufacturer |
Y |
| Superior Health Care Concepts d/b/a National
Wound Care |
Manufacturer |
N |
| Talley Medical, USA |
Manufacturer |
Y |
| MediTop BV |
Vendor Identified by AHRQ |
N |
| Kalypto Medical |
Vendor Identified by AHRQ |
N |
| Advanced Medical Technology Association (AdvaMed) |
Professional Organization |
N |
| American Academy of Dermatology |
Professional Organization |
N |
| American Association of Diabetes Educators |
Professional Organization |
N |
| American Burn Association |
Professional Organization |
N |
| American College of Surgeons |
Professional Organization |
N |
| American Diabetes Association |
Professional Organization |
N |
| American Professional Wound Care Association |
Professional Organization |
N |
| American Society of Plastic Surgeons |
Professional Organization |
N |
| Association for the Advancement of Wound
Care |
Professional Organization |
Y |
| Biotechnology Industry Organization (BIO) |
Professional Organization |
N |
| Medical Device Manufacturers Association |
Professional Organization |
N |
| National Pressure Ulcer Advisory Panel (NPUAP) |
Professional Organization |
N |
| Wound Care Institute |
Professional Organization |
N |
| Wound Healing Society |
Professional Organization |
N |
| Wound Ostomy and Continence Nurses Society |
Professional Organization |
Y |
| CMS |
Other |
Y |
| FDA |
Other |
N |
| K. Kowalske, M.D. (upon AHRQ's request) |
Other |
N |
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Table 14a. Total
Stakeholder Solicitations and Responses
| Type of Contact |
Total Number Contacted
by ECRI Institute |
Total Number
of Responses |
| Manufacturers |
9 |
6 |
| Additional vendors identified by AHRQ |
2 |
0 |
| Professional Organizations |
15 |
2 |
| Other: CMS & FDA |
2 |
1 |
| K. Kowalske, M.D. |
1 |
0 |
| Totals |
29 |
9 |
Notes:
- Initial contact was made on 12/30/08 via
e-mail and hard mail. Follow-up e-mails were sent on 01/29/09.
- 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.
- 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.
- This table does not reflect other unsolicited
responses received.
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