To test the hypothesis that strict asepsis in closing wounds following laparotomy reduces the risk for surgical wound infection in elective colorectal cancer surgery.
Multicenter randomized clinical trial conducted from June 1, 2009, through June 1, 2010.
Colorectal surgery units of 9 Spanish hospitals.
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.
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]).
This study does not support the use of rescrubbing to reduce the incidence of incisional surgical site infection.
isrctn.org Identifier: ISRCTN19463413