Skip Navigation Archive: U.S. Department of Health and Human Services U.S. Department of Health and Human Services
Archive: Agency for Healthcare Research Quality
Archival print banner

This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: Let us know the nature of the problem, the Web address of what you want, and your contact information.

Please go to for current information.

Disposition of Comments

Negative Pressure Wound Therapy Devices

Comments received from draft review on negative pressure wound therapy devices.

Project ID: WNDT1108

The Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment (TA) Program supports and is committed to the transparency of its review process. Therefore, invited peer review comments and public review comments are publicly posted on the TA Program Web site within 3 months after the associated final report is posted on this Web site.

This document presents the peer review comments and public review comments sent in response to the draft report, Negative Pressure Wound Therapy Devices, posted on the AHRQ Web site from April 10 to April 24, 2009. The final version of the report is available online.


Summary of Other Comments



Select for Table 1. Negative Pressure Wound Therapy (NPWT) Peer Reviewer Comments

Select for Table 2. Response to Public Comments on Negative Pressure Wound Therapy Devices Report (308 KB)


Summary of Other Comments

A total of 46 individuals did not use the mechanism established by AHRQ to submit their reviews and thus did not sign the disclosure statement. Their comments and our responses are presented in summary form.

Of these 46 reviewers, 35 reported having used more than one NPWT system, seven reported experience only with V.A.C.® Therapy while four made no report. A majority of the anonymous reviewers (n = 44 [96%]) specifically expressed support for V.A.C.® Therapy.

Most reviewers did not express concern with the NPWT report but did report their day-to-day experience with NPWT systems (n = 38 [83%]). Of the reviewers that expressed concern with the report; three reviewers only reported concern that the inclusion criteria were too restrictive. Two reviewers expressed support for the competitive bidding process. One reviewer only expressed concern that the lack of evidence on other NPWT systems did not extrapolate to superiority by V.A.C.® Therapy. One reviewer expressed concern with both the inclusion criteria and lack of superiority reported for V.A.C.® Therapy. Lastly, one reviewer provided attachments for possible inclusion in the report however did not provide comments regarding the report or experience with NPWT. Of the two submissions provided for possible inclusion in the report, one comparison study(54) was subsequently included in the discussion of Key Question 1 of the final report.

For those reviewers that reported anecdotal experience with NPWT systems, we would like to express our thanks for providing us with this important information. We will share this information with the Center for Medicare Management at CMS.

Some reviewers expressed concern that the inclusion/exclusion criteria for the report were too restrictive. Key questions were formulated for the report to test the hypothesis that a NPWT system or its components provided a significant therapeutic distinction compared to other NPWT systems or their components. These questions were structured using the "PICO" framework: patients, intervention of interest, comparator, and outcomes (go to Figure 1 of the report). Inclusion and exclusion criteria were methodically developed based on each key question prior to an examination of the evidence. Twelve inclusion criteria were established for this technology assessment (TA). In a TA, the inclusion criteria determine whether a study is "relevant" to the key questions. Studies that do not meet the inclusion criteria are excluded from the TA. Exclusion from the TA does not imply that the studies have no scientific merit, just that their findings are not applicable to answering a key question within the specific report. Next, we undertook an extensive search of the literature from which we identified over 1,000 potential articles. In the interest of identifying all clinically relevant materials for this report, we also invited interested stakeholders to submit information regarding any published, unpublished, or currently registered studies for possible inclusion in the report. We received over 1,400 submissions by the February 6, 2009 deadline. Each submission was reviewed for possible inclusion in the report (go to Appendix D).

The screening of all identified materials is a two-step process. An initial evaluation is done at the abstract level at which items may be excluded, used in our Background section or passed to the next level of evaluation. During the evaluation of all stakeholder submissions, we excluded 638 (44%) of the 1,435 submissions due to duplication alone (go to Figure 5 in Appendix D). Of the 797 (55% of original) unique submissions; 29 (4%) were included in our Background section and 269 (33%) items were excluded; 147 (56%) were case reports, abstracts or poster presentations given at conferences.

Of the 499 (35%) remaining articles, 354 (71%) were excluded at the article level. Based on the a priori inclusion/exclusion criteria, narrative reviews (k = 152 [43%]); animal studies (k = 39 [11%]); and studies with fewer than five patients in each arm (k = 30 [8%]) were excluded.

Of the 144 (10%) original submissions that met inclusion criteria, 117 (81%) were previously identified by the ECRI Institute literature searches. We subsequently included 28 studies not previously identified in our searches in the final report. Please go to Appendix D for additional details on individual submissions and subsequent disposition in the report.

The draft report has been thoroughly reviewed by four outside specialists in wound care. They have concurred that the report provides a thorough evaluation of the current evidence for NPWT systems.

Lastly, reviewers were concerned that the lack of evidence from other NPWT systems should demonstrate the superiority of V.A.C.® Therapy. It is important to note that due to the lack of published or unpublished studies that evaluated other NPWT systems we were unable to perform either direct or indirect comparisons. In the absence of such comparisons, ECRI Institute was unable to draw conclusions about the superiority or equivalence of any NPWT system or its components compared to another NPWT system or its components.

Return to Contents



1. Gregor S, Maegele M, Sauerland S, Krahn JF, Peinemann F, Lange S. Negative pressure wound therapy: a vacuum of evidence? Arch Surg 2008 Feb;143(2):189-96. PMID:18283145

2. 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. PMID:18675559

3. 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]. PMID:18646080

4. 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. PMID:9188970

5. Krasner DL. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage 2002 May;48(5):38-43. PMID:12046489

6. Long MA, Blevins A. Options in negative pressure wound therapy: five case studies. J Wound Ostomy Continence Nurs 2009 Mar-Apr;36(2):202-11. PMID:19287271

7. Willy C, editor. The theory and practice of vacuum therapy. Scientific basis, indications for use, case reports, practical advice. Ulm,Germany: Lindqvist book publishing; 2006. 405 p.

8. TriCenturion. Negative pressure wound therapy (NPWT) widespread probe results. Jurisdiction A - final report. Columbia (SC): TriCenturion; 2007 Feb. 2 p.

9. Hackam DG, Redelmeier DA. Translation of research evidence from animals to humans. JAMA 2006 Oct 11;296(14):1731-2. PMID:17032985

10. Hackam DG. Translating animal research into clinical benefit. BMJ 2007 Jan 27;334(7586):163-4. PMID:17255568

11. Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P, Macleod M, Mignini LE, Jayaram P, Khan KS. Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ 2007 Jan 27;334(7586):197-200. PMID:17175568

12. Agency for Healthcare Research and Quality (AHRQ). Methods reference guide for effectiveness and comparative effectiveness reviews, Version 1.0. [Draft posted Oct. 2007]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 128 p. Also�available: (PDF file, 1 MB; Plugin Software Help)

13. Fife CE, Otto G, Walker D, Thomson B, Carter MJ. A retrospective longitudinal study of the adverse events associated with the use of the VAC in a large wound-care population [unpublished]. 28 p.

14. Center for Biologics Evaluation and Research (CBER). Guidance for industry: chronic cutaneous ulcer and burn wounds - developing products for treatment. Rockville (MD): U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2006 Jun. 22 p. Also available: (PDF file, 205 KB)

15. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't [editorial]. BMJ 1996 Jan 13;312(7023):71-2. PMID:8555924

16. Morris S. Additional V1 failures/VAC rescues. 2006. 2 p.

17. Wild T, Stremitzer S, Budzanowski A, Hoelzenbein T, Ludwig C, Ohrenberger G. Definition of efficiency in vacuum therapy--a�randomised controlled trial comparing with V.A.C. Therapy. Int Wound J 2008 Dec;5(5):641-7. PMID:19134065

18. Jones SM, Banwell PE, Shakespeare PG. Interface dressings influence the delivery of topical negative-pressure therapy. Plast Reconstr Surg 2005 Sep 15;116(4):1023-8. PMID:16163089

19. 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.

20. Derrick KL, Norbury K, Kieswetter K, Skaf J, McNulty AK. Comparative analysis of global gene expression profiles between diabetic rat wounds treated with vacuum-assisted closure therapy, moist wound healing or gauze under suction. Int Wound J 2008 Dec;5(5):615-24. PMID:19134062

21. 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. PMID:18028132

22. McNulty AK, Schmidt M, Feeley T, Villanueva P, Kieswetter K. Effects of negative pressure wound therapy on cellular energetics in fibroblasts grown in a provisional wound (fibrin) matrix. Wound Repair Regen 2009 Mar-Apr;17(2):192-9.

23. 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. PMID:16327472

24. 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. PMID:19154071

25. 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. PMID:17003705

26. 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. PMID:17425550

27. 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. PMID:16291063

28. 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. PMID:15377721

29. 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. PMID:19037137

30. 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. PMID:18162494

31. Gabriel A, Heinrich C, Shores JT, Baqui WK, Rogers FR, Gupta S. Reducing bacterial bioburden in infected wounds with vacuum assisted closure and a new silver dressing - a pilot study. Wounds 2006 Sep;18(9):245-55.

32. Gabriel A, Heinrich C, Shores J, Cho D, Baqai W, Moores D, Miles D, Gupta S. Outcomes of vacuum-assisted closure for the treatment of wounds in a paediatric population: case series of 58 patients. J Plast Reconstr Aesthet Surg 2008 Oct 2;Epub ahead of print. PMID:18835547

33. Moisidis E, Heath T, Boorer C, Ho K, Deva AK. A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting. Plast Reconstr Surg 2004 Sep 15;114(4):917-22. PMID:15468399

34. 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. PMID:14974959

35. Moues CM, van den Bemd GJ, Heule F, Hovius SE. Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial. J Plast Reconstr Aesthet Surg 2007;60(6):672-81. PMID:17485058

36. 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. PMID:10687657

37. 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. PMID:18355797

38. Baharestani MM. Negative pressure wound therapy: an examination of cost-effectiveness. Ostomy Wound Manage 2004 Nov;50(11A�Suppl):29S-33S. PMID:15632465

39. Scherer LA, Shiver S, Chang M, Meredith JW, Owings JT, Tominaga GT, Schecter WP, Parks SN, Peck J, Mayberry J. The vacuum assisted closure device: a method of securing skin grafts and improving graft survival. Arch Surg 2002;137(8):930-4. PMID:12146992

40. 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. PMID:16874208

41. 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. PMID:16230764

42. Page JC, Newswander B, Schwenke DC, Hansen M, Ferguson J. Retrospective analysis of negative pressure wound therapy in open foot wounds with significant soft tissue defects. Adv Skin Wound Care 2004 Sep;17(7):354-64. PMID:15343085

43. 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. PMID:17651226

44. Flack S, Apelqvist J, Keith M, Trueman P, Williams D. An economic evaluation of VAC therapy compared with wound dressings in the treatment of diabetic foot ulcers. J Wound Care 2008 Feb;17(2):71-8. PMID:18389832

45. Gabriel A, Shores J, Heinrich C, Baqai W, Kalina S, Sogioka N, Gupta S. Negative pressure wound therapy with instillation: A pilot study describing a new method for treating infected wounds. Int Wound J 2008 Jun;5(3):399-413. PMID:18593390

46. Kaplan M. Negative pressure wound therapy in the management of abdominal compartment syndrome. Ostomy Wound Manage 2004 Nov;50(11A Suppl):20S-5S.

47. 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. PMID:17000077

48. Niezgoda JA. The economic value of negative pressure wound therapy. Ostomy Wound Manage 2005 Feb;51(2A Suppl):44-7. PMID:15699565

49. Siegel HJ, Long JL, Watson KM, Fiveash JB. Vacuum-assisted closure for radiation-associated wound complications. J Surg Oncol 2007 Dec 1;96(7):575-82. PMID:17999398

50. Moues CM, van den Bemd GJ, Meerding WJ, Hovius SE. An economic evaluation of the use of TNP on full-thickness wounds. J�Wound Care 2005 May;14(5):224-7. PMID:15909439

51. Song DH, Wu LC, Lohman RF, Gottlieb LJ, Franczyk M. Vacuum assisted closure for the treatment of sternal wounds: the bridge between debridement and definitive closure. Plast Reconstr Surg 2003 Jan;111(1):92-7. PMID:12496568

52. Frykberg RG, Williams DV. Negative-pressure wound therapy and diabetic foot amputations: a retrospective study of payer claims data. J Am Podiatr Med Assoc 2007 Sep-Oct;97(5):351-9. PMID:17901338

53. Carter MJ, Warriner RA 3rd. Evidence-based medicine in wound care: time for a new paradigm. Adv Skin Wound Care 2009 Jan;22(1):12-6. PMID:19096278

54. 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.

Return to Contents

Page last reviewed August 2014
Internet Citation: Disposition of Comments: Negative Pressure Wound Therapy Devices. August 2014. Agency for Healthcare Research and Quality, Rockville, MD.


The information on this page is archived and provided for reference purposes only.


AHRQ Advancing Excellence in Health Care