An international pragmatic randomized controlled trial to compare a single-use negative-pressure dressing versus the surgeon's preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy: the SUNRRISE trial protocol

Aim: Surgical site infection (SSI) is a common complication following emergency laparotomy, occurring in around 25% of patients in UK practice. The adoption of single-use negative-pressure dressings (SUNPDs) has been proposed as a prophylactic method of reducing the rate of SSI. The primary aim of the randomized controlled trial (RCT) described herein is to determine if a SUNPD reduces SSI at 30 days after an emergency laparotomy. Method: The Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy (SUNRRISE) study is an international, multicentre, pragmatic, phase III RCT with internal feasibility phase. As stated, the primary aim is to determine if a SUNPD reduces SSI at 30 days postoperatively. Patients will be randomized in a 1:1 ratio to receive either a SUNPD or a dressing of the surgeon's preference. Outcome assessors will be blinded to treatment allocation. The primary outcome measure is SSI within 30 days of surgery as defined by the US Centers for Disease Control criteria. A total of 840 patients will be required to detect a relative reduction of 40% in SSI rates (from 25% to 15%) with 90% power accounting for a 20% attrition rate. Discussion: SUNRRISE is an international, multicentre RCT evaluating the prophylactic use of SUNPD in primary closed emergency laparotomy wounds for the reduction of SSI. Our hypothesis is that a SUNPD is superior to the surgeon's preference of dressing in reducing SSIs at 30 days. The findings may influence dressing choice following emergency abdominal surgery in the future.