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 th...

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Bibliographic Details
Published in:Colorectal disease 2021-04, Vol.23 (4), p.989-1000
Main Authors: Wilkin, Richard, Clouston, Hamish, Coe, Peter, Duarte, Rui, Stott, Martyn, Pockney, Peter, Egoroff, Natasha, Mehta, Samir, Brown, James, Magill, Laura, Ives, Natalie, Fish, Rebecca, Glasbey, James, Duff, Sarah, Pinkney, Thomas, Johnstone, Elisabeth, Afzali, Hossein, Arthur, Thomas, Dawson, Amanda, Dudi‐Venkata, Nagendra N., Gramlick, Madelyn, Lam, Yick Ho, Muralidharan, Vijayaragavan, Park, Sean S. W., Richards, Toby, Sammour, Tarik, Stephensen, Bree, Stevens, Sean, Vo, Uyen Giao, Watson, David, Coffey, Tony, Cook, Nicola, Ghaneh, Paula, Haycox, Alan, Kaur, Manjinder, Platt, Kellie, Sehkar, Hema, Sinha, Yash, Waite, Kathryn
Format: Article
Language:English
Subjects:
Clinical trials
Dressings
Infections
Laparotomy
Patients
PICO dressing
Pressure
randomized controlled trial
Surgeons
Surgery
surgical site infection
Surgical site infections
topical negative pressure dressing
wound infection
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Summary: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.
ISSN:1462-8910
1463-1318
DOI:10.1111/codi.15474