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Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

Design Multicentre observer blinded randomised controlled trial.

Participants Patients undergoing laparotomy at 21 UK hospitals.

Interventions Standard care or the use of a wound edge protection device during surgery.

Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.

Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients …