Negative Pressure Wound Therapy: A Vacuum of Evidence? | Wound Care, Infection, Healing | JAMA Surgery | JAMA Network
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1.
Graham  IDHarrison  MBNelson  EALorimer  KFisher  A Prevalence of lower-limb ulceration: a systematic review of prevalence studies.  Adv Skin Wound Care 2003;16 (6) 305- 316PubMedGoogle ScholarCrossref
2.
Vermeulen  HUbbink  DTGoossens  Ade Vos  RLegemate  DA Systematic review of dressings and topical agents for surgical wounds healing by secondary intention.  Br J Surg 2005;92 (6) 665- 672PubMedGoogle ScholarCrossref
3.
Singh  AHalder  SMenon  GR  et al.  Meta-analysis of randomized controlled trials on hydrocolloid occlusive dressing versus conventional gauze dressing in the healing of chronic wounds.  Asian J Surg 2004;27 (4) 326- 332PubMedGoogle ScholarCrossref
4.
Winter  GD Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig.  Nature 1962;193293- 294PubMedGoogle ScholarCrossref
5.
Argenta  LCMorykwas  MJ Vacuum-assisted closure: a new method for wound control and treatment: clinical experience.  Ann Plast Surg 1997;38 (6) 563- 577PubMedGoogle ScholarCrossref
6.
Morykwas  MJArgenta  LCShelton-Brown  EIMcGuirt  W Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation.  Ann Plast Surg 1997;38 (6) 553- 562PubMedGoogle ScholarCrossref
7.
Morykwas  MJFaler  BJPearce  DJArgenta  LC Effects of varying levels of subatmospheric pressure on the rate of granulation tissue formation in experimental wounds in swine.  Ann Plast Surg 2001;47 (5) 547- 551PubMedGoogle ScholarCrossref
8.
Kinetic Concepts Inc, Annual report 2004: changing the standard of healing. http://library.corporate-ir.net/library/64/645/64595/items/148610/KCIAnnualReport.pdf. Accessed September 27, 2006
9.
Samson  DJLefevre  FAronson  N Wound Healing Technologies: Low Level Laser and Vacuum-Assisted Closure.  Rockville, MD Agency for Healthcare Research and Quality2004;AHRQ publication 05-E005-2
10.
Pham  CMiddleton  PMaddern  G Vacuum-Assisted Closure for the Management of Wounds: An Accelerated Systematic Review.  Adelaide Australian Safety and Efficacy Register of New Interventional Procedures-Surgical2003;ASERNIP-S Report No. 37
11.
Fisher  ABrady  B Vacuum assisted wound closure therapy.  Issues Emerg Health Technol 2003; (44) 1- 6PubMedGoogle Scholar
12.
Medical Advisory Secretariat; Ontario Health Technology Advisory Committee, Vacuum Assisted Closure Therapy for Wound Closure.  Toronto, Ontario Ontario Ministry of Health and Long-term Care2004;
13.
Sun  SYao  YLi  YHuang  XMa  XJinag  Y Mechanism and curative effect of vacuum sealing technique in treatment of wide chronic ulcer in the lower limbs in 24 cases [in Chinese].  Zhongguo Linchiuang Kangfu 2003;7577- 578Google Scholar
14.
Yao  YZHuang  XKMa  XL Treatment of traumatic soft tissue defect by vacuum sealing [in Chinese].  Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 2002;16 (6) 388- 390PubMedGoogle Scholar
15.
Davydov  YAAbramov  AYDarichev  AB Regulation of wound process by the method of vacuum therapy in middle-aged and aged patients [in Russian].  Khirurgiia (Mosk) 1994; (9) 7- 10Google Scholar
16.
IQWiG Steering Committee, Methods (version 1.0). http://www.iqwig.de/download/Methoden_IQWiG_V-1-0.pdf. Accessed September 27, 2006
17.
Buttenschön  KFleischmann  WHaupt  UKinzl  LButtenschön  DC The influence of vacuum-assisted closure on inflammatory tissue reactions in the postoperative course of ankle fractures.  Foot Ankle Surg 2001;7165- 173Google ScholarCrossref
18.
Jeschke  MGRose  CAngele  PFuchtmeier  BNerlich  MNBolder  U Development of new reconstructive techniques: use of Integra in combination with fibrin glue and negative-pressure therapy for reconstruction of acute and chronic wounds.  Plast Reconstr Surg 2004;113 (2) 525- 530PubMedGoogle ScholarCrossref
19.
Huang  JYao  YZHuang  XK Treatment of open fracture by vacuum sealing technique and internal fixation [in Chinese].  Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 2003;17 (6) 456- 458PubMedGoogle Scholar
20.
Armstrong  DGLavery  LA Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.  Lancet 2005;366 (9498) 1704- 1710PubMedGoogle ScholarCrossref
21.
Eginton  MTBrown  KRSeabrook  GRTowne  JBCambria  RA A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds.  Ann Vasc Surg 2003;17 (6) 645- 649PubMedGoogle ScholarCrossref
22.
Ford  CNReinhard  ERYeh  D  et al.  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) 55- 61PubMedGoogle ScholarCrossref
23.
Mouës  CMVos  MCvan den Bemd  GJStijnen  THovius  SE Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial.  Wound Repair Regen 2004;12 (1) 11- 17PubMedGoogle ScholarCrossref
24.
Mouës  CMvan den Bemd  GJMeerding  WJHovius  SE An economic evaluation of the use of TNP on full-thickness wounds.  J Wound Care 2005;14 (5) 224- 227PubMedGoogle ScholarCrossref
25.
Moisidis  EHeath  TBoorer  CHo  KDeva  AK A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting.  Plast Reconstr Surg 2004;114 (4) 917- 922PubMedGoogle ScholarCrossref
26.
Joseph  EHamori  CABergman  SRoaf  ESwann  NFAnastasi  GW A prospective randomized trial of vacuum-assisted closure versus standard therapy of chronic nonhealing wounds.  Wounds 2000;12 (3) 60- 67Google Scholar
27.
Wanner  MBSchwarzl  FStrub  BZaech  GAPierer  G Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study.  Scand J Plast Reconstr Surg Hand Surg 2003;37 (1) 28- 33PubMedGoogle ScholarCrossref
28.
Doss  MMartens  SWood  JPWolff  JDBaier  CMoritz  A Vacuum-assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis.  Eur J Cardiothorac Surg 2002;22 (6) 934- 938PubMedGoogle ScholarCrossref
29.
Genecov  DGSchneider  AMMorykwas  MJParker  DWhite  WLArgenta  LC A controlled subatmospheric pressure dressing increases the rate of skin graft donor site reepithelialization.  Ann Plast Surg 1998;40 (3) 219- 225PubMedGoogle ScholarCrossref
30.
Kamolz  LPAndel  HHaslik  WWinter  WMeissl  GFrey  M Use of subatmospheric pressure therapy to prevent burn wound progression in human: first experiences.  Burns 2004;30 (3) 253- 258PubMedGoogle ScholarCrossref
31.
Page  JCNewswander  BSchwenke  DCHansen  MFerguson  J Retrospective analysis of negative pressure wound therapy in open foot wounds with significant soft tissue defects.  Adv Skin Wound Care 2004;17 (7) 354- 364PubMedGoogle ScholarCrossref
32.
Scherer  LAShiver  SChang  MMeredith  JWOwings  JT The vacuum assisted closure device: a method of securing skin grafts and improving graft survival.  Arch Surg 2002;137 (8) 930- 934PubMedGoogle ScholarCrossref
33.
Schrank  CMayr  MOveresch  M  et al.  Results of vacuum therapy (V.A.C.) of superficial and deep dermal burns [in German].  Zentralbl Chir 2004;129 ((suppl 1)) S59- S61PubMedGoogle ScholarCrossref
34.
Stone  PPrigozen  JHofeldt  MHass  SDeLuca  JFlaherty  S Bolster versus negative pressure wound therapy for securing split-thickness skin grafts in trauma patients.  Wounds 2004;16 (7) 219- 223Google Scholar
35.
Wild  TStremitzer  SBudzanowski  A  et al.  “Abdominal dressing:” a new method of treatment for open abdomen following secondary peritonitis [in German].  Zentralbl Chir 2004;129 ((suppl 1)) S20- S23PubMedGoogle ScholarCrossref
36.
McCallon  SKKnight  CAValiulus  JPCunningham  MWMcCulloch  JMFarinas  LP Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds.  Ostomy Wound Manage 2000;46 (8) 28- 32, 34PubMedGoogle Scholar
37.
Etöz  AÖzgenel  YÖzcan  M The use of negative pressure wound therapy on diabetic foot ulcers: a preliminary controlled trial.  Wounds 2004;16 (8) 264- 269Google Scholar
38.
Stannard  JPRobinson  JTAnderson  ERMcGwin  G  JrVolgas  DAAlonso  JE Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma.  J Trauma 2006;60 (6) 1301- 1306PubMedGoogle ScholarCrossref
39.
Armstrong  DGLavery  LA Negative pressure therapy in diabetic foot wounds [authors' reply].  Lancet 2006;367 (9512) 726- 727PubMedGoogle ScholarCrossref
40.
US Department of Health and Human Services; Food and Drug Administration, Center for Biologic Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), Center for Drug Evaluation and Research (CDER), Guidance for industry: chronic cutaneous ulcer and burn wounds: developing products for treatment. http://www.fda.gov/Cber/gdlns/ulcburn.htm. Accessed September 27, 2006
41.
Braakenburg  AObdeijn  MCFeitz  Rvan Rooij  IALMvan Griethuysen  AJKlinkenbijl  JHG 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;118 (2) 390- 400PubMedGoogle ScholarCrossref
42.
Lewis  RWhiting  Pter Riet  GO'Meara  SGlanville  J A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention.  Health Technol Assess 2001;5 (14) 1- 131PubMedGoogle Scholar
43.
Dinah  FAdhikari  A Gauze packing of open surgical wounds: empirical or evidence-based practice?  Ann R Coll Surg Engl 2006;88 (1) 33- 36PubMedGoogle ScholarCrossref
44.
Cook  DJGuyatt  GHRyan  G  et al.  Should unpublished data be included in meta-analyses? current convictions and controversies.  JAMA 1993;269 (21) 2749- 2753Google ScholarCrossref
45.
Eysenbach  GTuische  JDiepgen  TL Evaluation of the usefulness of Internet searches to identify unpublished clinical trials for systematic reviews.  Med Inform Internet Med 2001;26 (3) 203- 218PubMedGoogle ScholarCrossref
46.
Evans  DLand  L Topical negative pressure for treating chronic wounds.  Cochrane Database Syst Rev 2001;1 (1) CD001898PubMedGoogle Scholar
47.
Moher  DSchulz  KFAltman  D The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.  JAMA 2001;285 (15) 1987- 1991PubMedGoogle ScholarCrossref
48.
Maegele  MGregor  SPeinemann  FSauerland  S Negative pressure therapy in diabetic foot wounds.  Lancet 2006;367 (9512) 725- 726PubMedGoogle ScholarCrossref
49.
Willy  C Vacuum Therapy: Basics, Indications, Case Reports, Practical Hints [in German].  Altusried-Krugzell, Germany Kösel GmbH & Co KG2005;
50.
Sacks  HChalmers  TCSmith  H  Jr Randomized versus historical controls for clinical trials.  Am J Med 1982;72 (2) 233- 240PubMedGoogle ScholarCrossref
51.
Maegele  MGregor  SSteinhausen  E  et al.  The long-distance tertiary air transfer and care of tsunami victims: injury pattern and microbiological and psychological aspects.  Crit Care Med 2005;33 (5) 1136- 1140PubMedGoogle ScholarCrossref
52.
Altman  DGBland  JM Absence of evidence is not evidence of absence.  BMJ 1995;311 (7003) 485PubMedGoogle ScholarCrossref
Review
February 1, 2008

Negative Pressure Wound Therapy: A Vacuum of Evidence?

Author Affiliations

Author Affiliations: Departments of Abdominal, Vascular, and Transplantation Surgery (Dr Gregor) and Trauma/Orthopedic Surgery (Dr Maegele) and Institute for Research in Operative Medicine (Drs Sauerland and Krahn), University of Witten/Herdecke, and Institute for Quality and Efficiency in Health Care (Drs Peinemann and Lange), Cologne; and Department of Abdominal, Thoracic, and Vascular Surgery, Regional Hospital Gummersbach, (Dr Gregor), Gummersbach, Germany.

Arch Surg. 2008;143(2):189-196. doi:10.1001/archsurg.2007.54
Abstract

Objective  To systematically examine the clinical effectiveness and safety of negative pressure wound therapy (NPWT) compared with conventional wound therapy.

Data Sources  MEDLINE, EMBASE, CINAHL, and the Cochrane Library were searched. Manufacturers were contacted, and trial registries were screened.

Study Selection  Randomized controlled trials (RCTs) and non-RCTs comparing NPWT and conventional therapy for acute or chronic wounds were included in this review. The main outcomes of interest were wound-healing variables. After screening 255 full-text articles, 17 studies remained. In addition, 19 unpublished trials were found, of which 5 had been prematurely terminated.

Data Extraction  Two reviewers independently extracted data and assessed methodologic quality in a standardized manner.

Data Synthesis  Seven RCTs (n = 324) and 10 non-RCTs (n = 278) met the inclusion criteria. The overall methodologic quality of the trials was poor. Significant differences in favor of NPWT for time to wound closure or incidence of wound closure were shown in 2 of 5 RCTs and 2 of 4 non-RCTs. A meta-analysis of changes in wound size that included 4 RCTs and 2 non-RCTs favored NPWT (standardized mean difference: RCTs, −0.57; non-RCTs, −1.30).

Conclusions  Although there is some indication that NPWT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. The large number of prematurely terminated and unpublished trials is reason for concern.

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