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
Grp, S. S.
Grp, S. S.
Northwest Res, C.
West Midlands Res, C.
AffiliationSUNRRISE Study Group on behalf of the Northwest Research Collaborative and the West Midlands Research Collaborative
MetadataShow full item record
AbstractBackground: 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.
CitationWilkin R, Clouston H, Coe P, Duarte R, Stott M, et al. 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. Colorectal Dis [Internet]. 2021 Feb 3
- Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.
- Authors: Reeves BC, Rooshenas L, Macefield RC, Woodward M, Welton NJ, Waterhouse BR, Torrance AD, Strong S, Siassakos D, Seligman W, Rogers CA, Rickard L, Pullyblank A, Pope C, Pinkney TD, Pathak S, Owais A, O'Callaghan J, O'Brien S, Nepogodiev D, Nadi K, Murkin CE, Munder T, Milne T, Messenger D, McMullan CM, Mathers JM, Mason M, Marshall M, Lovegrove R, Longman RJ, Lloyd J, Lim J, Lee K, Korwar V, Hughes D, Hill G, Harris R, Hamdan M, Brown HG, Gooberman-Hill R, Glasbey J, Fryer C, Ellis L, Elliott D, Dumville JC, Draycott T, Donovan JL, Cotton D, Coast J, Clout M, Calvert MJ, Byrne BE, Brown OD, Blencowe NS, Bera KD, Bennett J, Bamford R, Bakhbakhi D, Atif M, Ashton K, Armstrong E, Andronis L, Ananthavarathan P, Blazeby JM
- Issue date: 2019 Aug
- Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT.
- Authors: Costa ML, Achten J, Knight R, Png ME, Bruce J, Dutton S, Madan J, Vadher K, Dritsaki M, Masters J, Spoors L, Campolier M, Parsons N, Fernandez M, Jones S, Grant R, Nanchahal J
- Issue date: 2020 Aug
- Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial.
- Authors: O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, Hickey K, Coffey JC
- Issue date: 2017 Jun
- Prophylactic negative pressure wound therapy for closed laparotomy wounds: a systematic review and meta-analysis of randomised controlled trials.
- Authors: Boland PA, Kelly ME, Donlon NE, Bolger JC, Mehigan BJ, McCormick PH, Larkin JO
- Issue date: 2021 Feb
- Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds.
- Authors: Blazeby J, Bluebelle Study Group.
- Issue date: 2020 Jan 12