Elsevier

Journal of Vascular Surgery

Volume 44, Issue 5, November 2006, Pages 1029-1037
Journal of Vascular Surgery

Clinical research study
State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings

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Background

Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a subatmospheric pressure by vacuum-assisted closure (V.A.C., KCI Concepts, San Antonio, Texas) therapy supports the wound healing process.

Methods

The efficacy of vacuum-assisted closure in the treatment of chronic leg ulcers was prospectively studied in a randomized controlled trial in which 60 hospitalized patients with chronic leg ulcers were randomly assigned to either treatment by V.A.C. or therapy with conventional wound care techniques. The primary outcome measure was the time to complete healing (days). Statistical analysis was performed on the intention-to-treat basis.

Results

The median time to complete healing was 29 days (95% confidence interval [CI], 25.5 to 32.5) in the V.A.C. group compared with 45 days (95% CI, 36.2 to 53.8) in the control group (P = .0001). Further, wound bed preparation during V.A.C. therapy was also significantly shorter at 7 days (95% CI 5.7 to 8.3) than during conventional wound care at 17 days (95% CI, 10 to 24, P = .005). The costs of conventional wound care were higher than those of V.A.C. Both groups showed a significant increase in quality of life at the end of therapy and a significant decrease in pain scores at the end of follow-up.

Conclusions

V.A.C. therapy should be considered as the treatment of choice for chronic leg ulcers owing to its significant advantages in the time to complete healing and wound bed preparation time compared with conventional wound care. Particularly during the preparation stage, V.A.C. therapy appears to be superior to conventional wound care techniques.

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The study was supported by the Dutch department of Kinetic Concepts, Inc (KCI). KCI had no influence or vote regarding study design, data collection, data analysis, data interpretation, writing of the report, or in the decision to submit the manuscript for publication.

Competition of interest: none.

CME article