Christina Monsen1, Christine Wann-Hansson2, Catharina Wictorsson3, Stefan Acosta3. 1. Vascular Center, Malmö-Lund, Skåne University Hospital, Malmö, Sweden. Electronic address: christina.monsen@skane.se. 2. Department of Care Science, Malmö University, Malmö, Sweden; The Swedish Institute of Health Sciences, Lund University, Lund, Sweden. 3. Vascular Center, Malmö-Lund, Skåne University Hospital, Malmö, Sweden.
Abstract
BACKGROUND:Vacuum-assisted wound closure (VAC) therapy may heal wounds faster than conventional dressings after surgical debridement of perivascular groin infections after vascular surgery. METHODS:Patients with deep infected wounds (Szilagyi grade III) were surgically revised and left open for secondary healing, then randomized to either VAC or alginate (Sorbalgon) therapy, between February 2007 and November 2011. To test the hypothesis, it was calculated that 42 patients needed to be included (90% power, 5% level of significance). It was decided to perform an interim analysis after inclusion of 20 patients. RESULTS: Among 66 patients undergoing groin revision, 20 patients were included in this study. Patients were randomized to VAC (n = 10) or alginate (n = 10). The two groups were comparable in patient and wound characteristics. Time to full skin epithelialization was significantly shorter in the VAC group (median, 57 days) compared with the alginate group (median, 104 days; P = .026). The number of positive wound cultures of bacteria and C-reactive protein values decreased equally in both groups between surgical revision and day 21. One femur amputation was performed in each group as a consequence of the groin infection, one patient died during the in-hospital stay in the alginate group, and none died in the VAC group. CONCLUSIONS:VAC achieves faster healing than alginate therapy after wound debridement for deep perivascular wound infections in the groin after vascular surgery. This finding does not allow further inclusion of patients from an ethical point of view, and this study was, therefore, stopped prematurely.
RCT Entities:
BACKGROUND: Vacuum-assisted wound closure (VAC) therapy may heal wounds faster than conventional dressings after surgical debridement of perivascular groin infections after vascular surgery. METHODS:Patients with deep infected wounds (Szilagyi grade III) were surgically revised and left open for secondary healing, then randomized to either VAC or alginate (Sorbalgon) therapy, between February 2007 and November 2011. To test the hypothesis, it was calculated that 42 patients needed to be included (90% power, 5% level of significance). It was decided to perform an interim analysis after inclusion of 20 patients. RESULTS: Among 66 patients undergoing groin revision, 20 patients were included in this study. Patients were randomized to VAC (n = 10) or alginate (n = 10). The two groups were comparable in patient and wound characteristics. Time to full skin epithelialization was significantly shorter in the VAC group (median, 57 days) compared with the alginate group (median, 104 days; P = .026). The number of positive wound cultures of bacteria and C-reactive protein values decreased equally in both groups between surgical revision and day 21. One femur amputation was performed in each group as a consequence of the groin infection, one patient died during the in-hospital stay in the alginate group, and none died in the VAC group. CONCLUSIONS: VAC achieves faster healing than alginate therapy after wound debridement for deep perivascular wound infections in the groin after vascular surgery. This finding does not allow further inclusion of patients from an ethical point of view, and this study was, therefore, stopped prematurely.
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