O Haase1, W Raue, B Böhm, H Neuss, M Scharfenberg, W Schwenk. 1. Department of General, Visceral, Vascular and Thoracic Surgery, University Medicine Berlin, Berlin, Germany. oliver.haase@charite.de
Abstract
BACKGROUND:After loop-ileostomy closure subcutaneous wound infection is the most frequent postoperative complication. Implantation of local antibiotics has been shown to reduce the incidence of wound infection after different surgical procedures, therefore, a subcutaneous application of a gentamycin implant may also decrease infection rate after ileostomy-closure. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of a subcutaneous gentamycin-collagen implant to reduce wound infectionafter loop-ileostomy closure. Patients had the same perioperative treatment and standardized anastomotic and closure technique. A collagen sponge with gentamycin was used in the treatment group and an identical collagen implant without antibiotics was used in the placebo group. RESULTS:Eighty patients (40 per group) were included. There was no difference between the groups with respect to demographics or in the postoperative course. The total wound infection rate was 10 percent with no difference between the gentamycin (n=4) and the collagen group (n=4) (P = 1.0). CONCLUSION: Subcutaneous implantation of a gentamycin sponge yields no clinically relevant reduction of the wound infection rateafter loop-ileostomy closure so that routine use is not recommended in this procedure.
RCT Entities:
BACKGROUND: After loop-ileostomy closure subcutaneous wound infection is the most frequent postoperative complication. Implantation of local antibiotics has been shown to reduce the incidence of wound infection after different surgical procedures, therefore, a subcutaneous application of a gentamycin implant may also decrease infection rate after ileostomy-closure. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of a subcutaneous gentamycin-collagen implant to reduce wound infection after loop-ileostomy closure. Patients had the same perioperative treatment and standardized anastomotic and closure technique. A collagen sponge with gentamycin was used in the treatment group and an identical collagen implant without antibiotics was used in the placebo group. RESULTS: Eighty patients (40 per group) were included. There was no difference between the groups with respect to demographics or in the postoperative course. The total wound infection rate was 10 percent with no difference between the gentamycin (n=4) and the collagen group (n=4) (P = 1.0). CONCLUSION: Subcutaneous implantation of a gentamycin sponge yields no clinically relevant reduction of the wound infection rate after loop-ileostomy closure so that routine use is not recommended in this procedure.
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