RESUMO
OBJECTIVE: To test the hypothesis that strict asepsis in closing wounds following laparotomy reduces the risk for surgical wound infection in elective colorectal cancer surgery. DESIGN: Multicenter randomized clinical trial conducted from June 1, 2009, through June 1, 2010. SETTINGS: Colorectal surgery units of 9 Spanish hospitals. PATIENTS: A total of 969 patients who underwent elective colorectal cancer surgery were eligible for randomization. In closing the laparotomy wound, the patients were randomized to 2 groups: conventional (n=516) and new operation (n=453). In the conventional group, a new set of instruments was used, surgical staff changed their gloves, and the surgical drapes surrounding the laparotomy were covered by a new set of drapes. The new operation group involved removing all drapes, the surgical staff scrubbed again, and a new set of drapes and instruments was used. MAIN OUTCOME MEASURES: Incisional (superficial and deep) surgical site infection 30 days after the operation and risk factors for postoperative wound infections. RESULTS: A total of 146 incisional surgical site infections (15.1%) were diagnosed. Of these, 96 (9.9%) were superficial and 50 (5.1%) were deep infections. On an intent-to-treat basis, significant differences were found between both groups (66 [12.8%] in the conventional group vs 80 [17.7%] in the new operation group [P=.04]). CONCLUSION: This study does not support the use of rescrubbing to reduce the incidence of incisional surgical site infection. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN19463413