This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citing articles on ISI (1)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Surgical Infections  • Review  • Dermatology  • Wound Healing  • Alert me on articles by topic

A Vacuum of Evidence?

Sven Gregor, MD; Marc Maegele, MD; Stefan Sauerland, MD, MPH; Jan F. Krahn, MD; Frank Peinemann, MD; Stefan Lange, MD, PhD

Arch Surg. 2008;143(2):189-196.

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 In addition, 19 unpublished trials were found, of which 5 had been prematurely terminated.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 The large number of prematurely terminated and unpublished trials is reason for concern.

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.