An international pragmatic randomised controlled trial to compare a single use negative pressure dressing versus a surgeon’s preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy: the SUNRRISE Trial Protocol

Research output: Contribution to journalArticlepeer-review

Standard

An international pragmatic randomised controlled trial to compare a single use negative pressure dressing versus a surgeon’s preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy : the SUNRRISE Trial Protocol. / The SUNRRISE Study Group on behalf of the Northwest Research Collaborative and the West Midlands Research Collaborative.

In: Colorectal Disease, 03.02.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

APA

Vancouver

Author

Bibtex

@article{5ce85f1a4d85458fa0da33461c162a0e,
title = "An international pragmatic randomised controlled trial to compare a single use negative pressure dressing versus a surgeon{\textquoteright}s preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy: the SUNRRISE Trial Protocol",
abstract = "Background: Surgical site infection (SSI) is a common complication following emergency laparotomy occurring in around 25% of patients in UK practice. The use of single use negative pressure dressings (SUNPDs) for these wounds has been proposed as a prophylactic method of reducing the rate of SSI. 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 randomised controlled trial (RCT) with internal feasibility phase. The primary aim is to determine if a single use negative pressure dressing (SUNPD) reduces surgical site infection (SSI) at 30 days post-operatively. Patients will be randomised in a 1:1 ratio to either a SUNPD or to receive a dressing of the surgeon{\textquoteright}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 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 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{\textquoteright}s preference of dressing in reducing surgical site infections at 30 days. These findings may influence dressing choice following emergency abdominal surgery in the future.",
author = "{The SUNRRISE Study Group on behalf of the Northwest Research Collaborative and the West Midlands Research Collaborative} and Richard Wilkin and Hamish Clouston and Peter Coe and Rui Duarte and Martyn Stott and Peter Pockney and Natasha Egoroff and Samir Mehta and James Brown and Laura Magill and Natalie Rowland and Rebecca Fish and James Glasbey and Sarah Duff and Thomas Pinkney",
year = "2021",
month = feb,
day = "3",
doi = "10.1111/codi.15474",
language = "English",
journal = "Colorectal Disease",
issn = "1462-8910",
publisher = "Wiley",

}

RIS

TY - JOUR

T1 - An international pragmatic randomised controlled trial to compare a single use negative pressure dressing versus a surgeon’s preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy

T2 - the SUNRRISE Trial Protocol

AU - The SUNRRISE Study Group on behalf of the Northwest Research Collaborative and the West Midlands Research Collaborative

AU - Wilkin, Richard

AU - Clouston , Hamish

AU - Coe , Peter

AU - Duarte, Rui

AU - Stott , Martyn

AU - Pockney , Peter

AU - Egoroff, Natasha

AU - Mehta, Samir

AU - Brown, James

AU - Magill, Laura

AU - Rowland, Natalie

AU - Fish , Rebecca

AU - Glasbey, James

AU - Duff, Sarah

AU - Pinkney, Thomas

PY - 2021/2/3

Y1 - 2021/2/3

N2 - Background: Surgical site infection (SSI) is a common complication following emergency laparotomy occurring in around 25% of patients in UK practice. The use of single use negative pressure dressings (SUNPDs) for these wounds has been proposed as a prophylactic method of reducing the rate of SSI. 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 randomised controlled trial (RCT) with internal feasibility phase. The primary aim is to determine if a single use negative pressure dressing (SUNPD) reduces surgical site infection (SSI) at 30 days post-operatively. Patients will be randomised in a 1:1 ratio to either a SUNPD or to receive 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 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 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 surgical site infections at 30 days. These findings may influence dressing choice following emergency abdominal surgery in the future.

AB - Background: Surgical site infection (SSI) is a common complication following emergency laparotomy occurring in around 25% of patients in UK practice. The use of single use negative pressure dressings (SUNPDs) for these wounds has been proposed as a prophylactic method of reducing the rate of SSI. 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 randomised controlled trial (RCT) with internal feasibility phase. The primary aim is to determine if a single use negative pressure dressing (SUNPD) reduces surgical site infection (SSI) at 30 days post-operatively. Patients will be randomised in a 1:1 ratio to either a SUNPD or to receive 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 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 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 surgical site infections at 30 days. These findings may influence dressing choice following emergency abdominal surgery in the future.

U2 - 10.1111/codi.15474

DO - 10.1111/codi.15474

M3 - Article

JO - Colorectal Disease

JF - Colorectal Disease

SN - 1462-8910

ER -