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State-of-the-art treatment of chronic leg ulcers: a randomized controlled trial comparing vacuum-assisted closure (VAC) with modern wound dressings |
Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC |
Journal of Vascular Surgery 2006 Nov;44(5):1029-1037 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 (VAC, 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 VAC 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 VAC group compared with 45 days (95% CI, 36.2 to 53.8) in the control group (p = 0.0001). Further, wound bed preparation during VAC 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 = 0.005). The costs of conventional wound care were higher than those of VAC. 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: VAC 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, VAC therapy appears to be superior to conventional wound care techniques.
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