Negative Pressure Dressings to Prevent Surgical Site Infection After Emergency Laparotomy
Authors:   SUNRRISE Trial Study Group, Brown James , Clouston Hamish , Coe Pete , Duarte Rui , Duff Sarah , Fish Rebecca , Ghaneh Paula , Glasbey James , Ives Natalie , Johnston Elisabeth , Kaur Manjinder , Magill Laura , Mehta Samir , Pinkney Tom , Platt Kellie , Pockney Peter , Sekhar Hema , Sinha Yash , Stott Martyn , Wilkin Richard , Afzali Hossein , Angerami Almeida Kaylani , Arthur Tom , Atherton Kristy , Chew Kenneth , D'Aulerio Giuliana , Dawson Amanda , Dudi-Venkata Nagendra , Egoroff Natasha , Fitzsimmons Tracy , Gelzinnis Scott , Gramlick Maddie , Knoblauch Naomi , Lott Natalie , Lun Elizabeth , Muralidharan Vijayaragavan , Penna Kat , Richards Toby , Riddiough Georgina , Ryan Suzanne , Sammour Tarik , Stanton Sarah , Stephensen Bree , Stevens Sean , Uyen Vo , Watson David , Zhou Xuanyu , Corrigan Neil , Costa Matt , Osborn Lesley , Gomez Ruiz Marcos , Dumville Joanne , Hall Nigel , Yu Ly-Mee , Bermingham Helen , Dilworth Mark , Filippa Athanasia , Kharodia Tabinda , Stamatiou Dimitrios , Barnett Amy , Blackmore Alex , Hickey Lorraine , Melling Sarah , Podesta Carl , Hogben Karen , Ng Paula , Oglesby Abby , O'Neill Edel , Premakumar Yaamini , Youssef Fahed , Ahmed Ahmed , Boddy Alex , Bown Emma , Cooke Jill , Hossain Tanvir , Hunter David , Khasawneh Farah , McDonald Rosie , Mohamed Mohamed , Neal Chris , Palser Tom , Rattay Tim , Zain Butt Hisham , Abulkhir Adel , Al-Khaddar Ziad , Amin Khalid , Bogdan Monica , Bughio Mumtaz , Habeeb Kayode , Jowle Debra , Kennedy-Dalby Andrew , Khan Usman , Reynolds Jennifer , Sadat Mohammed , Shami Samer , Smart Chris J , Townley Barbara , Ward Simon , Wassall Helen , Wilkinson Lesley , Haffenden Verity , Macutkiewicz Christian , Newton Katy , Palacios April , Roberts Katie , Blans Alison , Chang Jessica , Davies Kathryn , Hardwick Alison , Nnaji Martin , Roberts Julie , Yassin Nuha A , Convery Karen , Fuentes-Warr Joana , Hudig Lisa , Lewis Michael , Rankin Adele , Brown Steve , Coe Peter , Lee Matthew , O'Connor Timothy , Steele Caroline , Wheldon Luke , Sayers Adele , Butcher Deborah , Dennis Robert , Ghosh Soumendu , O'Sullivan Susan , Ali Muhammed , Ball Alasdair , Buckingham Elizabeth , Garner Sharon , Griffiths Ewen , Malik Kamran , McNeill Claire , Nassar Ahmed , Newton Nicholas , Oliveira Cunha Melissa , Pinkney Thomas , Richardson Jonathan , Snelling Samuel , Tan Benjamin , Ward Stephen , Whitehouse Arlo , Wolfenden Hugo , Wright Deborah , Curtis Joanna , Topham Kirsty , Welch Neil , Clark Maggie , Edwards Jennifer , Moug Susan , Timalapur Shashi , Duberley Stephan , Fitchett Jillian , Heywood Nick , Jones Lyndon , Chadwick Julie , Dawe Christine , Faulkner Gemma , Hammill Christa , Hull Robert , Martinez-Iglesias Marta , Rajamanickam Shenbaga , Silva Natalie , Turnbull Jack , Keen Anne , Knowles Karen , Mason Clare , McAlpine Lesley , Pearce Lyndsay , Rees Adam , Slade Dominic , Thomas Vicky , Albendary Mohamed , Colley Julie , Joseph Sibet , Porter Jenny , Stonelake Stephen , Torrance Andrew , Zaman Shafquat , Hall Claire , Joshi Nachiket , Marrs Janet , Nulty Callula , Bajwa Adeel , Stokes Chelsea , Williams Greg , Baker Annalie , Campbell Bridget , Ho William , Imran Aslam Muhammad , Konstantinou Charalampos , Marriott Paul , Balance Laura , Biju Alphonsa , Brown Ayla , Brown Benjamin , Byrne Caroline , Fatayer Taher , Hine Rachel , Hussain Tasadooq , Jackson Raef , Mamunur Rahman Mohammed , McCormick Richard , McNally George , Ninan Preethy , Noone Tracy , Patel Meera , Redfern Jennifer , Roy Jyotimoy , Staight Sarah , Storey Sharon , Varley Rebecca , Cox Danile , Campbell Cassidy , Iqbal Ramiz , Park Sean , Cheung Henry , Goonawardhana Dulani , Huynh Roy , Xinyi Zhang , Davis Amelia , Jurat Danika , Lovelle Loh Pamphila , McMillan Hayley , Trivedi Anand , Vo Uyen , Afzal Mohammed A , Barreto Savio G , Fong Rebecca , Grantham James , Gricks Benjamin , Hii Amanda , Kundu Nikhil , Lam Yick Ho , Liu David , Livingston Charles , Nair Gavin , Ong Beeshan , Pickering Olivia , Traeger Like , Vissapragada Ravi , Wee Melissa , Lavigne Jordan , Townend Philip , Clark Sara , Drana Andrew , Loh Eu Jhin , Widjaja Winy , Ahmad Alam , Chern Tien Yew , Christie Adam , Di Sano Suzanne , Elkawaga Mostafa , Fenton Mark , Gramlick Madelyn , Griffiths Benjamin , Gupta Saksham , Holmes Merran , McIlroy Daniel , Peters Luke , Petersson Josefine , Smith Stephen , Wiadji Elvina , Zhao Jie , Asokan Gayatri , Barbaro Antonio , Besanko James , Chugha Amandeep , Dudi-Vankata Nagendra , Duffield Jaime , Ganguly Timothy , Haque Izhar-Ul , Herath Matheesha , Kroon Hidde , Lam Alicia , Lun Victoria , Nguyen Alain , Ong Daniel , Tran Steven , Van de Ven Luci , Vather Ryash , Willet Jake , Wong Geoffrey , Archer Leigh , Dilevska Tina , Foo Jonathan , Hudson David , Martin Sasha , Ongso Ynui , Tee Yeow Chun , Trinder Matthew , Walsh Nicole , Zhao Bichen , Garaghty Keith , Harrison Benjamin , Tan Patrick , Barnard Paige , Choi Kit-Suen , Hempenstall Lucy , Long Brittany , Narsey Nikhil , Savage Gabriella , Tang Hannah , Brailsford Kate , Khan Erum , Rai Gurmail , Rowland Natalie , Atherton Kristy , Brown James , Clouston Hamish , Coe Pete , Duarte Rui , Dudi-Venkata Nagendra N. , Duff Sarah , Egoroff Natasha , Fish Rebecca , Glasbey James , Ives Natalie , Kaur Manjinder , Magill Laura , Mehta Samir , Pinkney Thomas , Pockney Peter , Richards Toby , Sammour Tarik , Sekhar Hema , Sinha Yash , Stott Martyn , Wilkin Richard 
Published: January 2025

Importance

Patients undergoing unplanned abdominal surgical procedures are at increased risk of surgical site infection (SSI). It is not known if incisional negative pressure wound therapy (iNPWT) can reduce SSI rates in this setting.

Objective

To evaluate the effectiveness of iNPWT in reducing the rate of SSI in adults undergoing emergency laparotomy with primary skin closure.

Design, Setting, and Participants

SUNRRISE was an assessor-masked, pragmatic, phase 3, individual-participant, randomized clinical trial. Adult patients undergoing emergency laparotomy in 22 hospitals in the UK and 12 hospitals in Australia between December 18, 2018, and May 25, 2021, were recruited. Patients were followed up for 30 days postprocedure; database closure was on August 25, 2021.

Interventions

Participants were randomized 1:1 to receive iNPWT (n = 411), which involved a specialized dressing used to create negative pressure over the closed wound vs the surgeon’s choice of wound dressing (n = 410). Randomization and dressing application occurred in the operating room at the end of the surgical procedure.

Main Outcomes and Measures

The primary outcome measure was SSI up to 30 days postprocedure, evaluated by an assessor masked to the randomized allocation and using criteria from the US Centers for Disease Control and Prevention. There were 7 secondary outcomes, including length of hospital stay, postoperative complications up to 30 days, hospital readmission for wound-related complications within 30 days, wound pain, and quality of life.

Results

A total of 840 patients were randomized (536 from the UK; 304 from Australia). Overall, 52% were female; the mean age was 63.8 (range, 18.8 to 95.3) years. After postrandomization exclusions (N = 52), 394 participants per group were included in the primary analysis. The number of participants who had an SSI in the iNPWT group was 112 of 394 (28.4%), compared with 108 of 394 (27.4%) in the surgeon’s preference group (relative risk, 1.03 [95% CI, 0.83-1.28]; P = .78). This finding was consistent across the preplanned subgroup analyses, including degree of contamination, presence of a stoma, participant body mass index, and skin preparation used, and across all preplanned sensitivity analyses. Of 7 secondary outcomes, 6 showed no significant difference, including hospital readmission, quality of life, and hospital stay (median [IQR], 8 [6-14] days in the iNPWT group and 9 [6-14.5] days in the surgeon’s preference group [ratio of geometric means, 0.96 (95% CI, 0.88-1.06); P = .21]).

Conclusions and Relevance

Routine application of iNPWT to the closed surgical wound after emergency laparotomy did not prevent SSI more than other dressings.

Trial Registration

isrctn.com Identifier: ISRCTN17599457; anzctr.org.au Identifier: ACTRN12619000496112