ADding negative pRESSure to improve healING (the DRESSING trial): a RCT protocol

Gillespie, Brigid M, Webster, Joan, Ellwood, David, Stapleton, Helen, Whitty, Jennifer A, Thalib, Lukman, Cullum, Nicky, Mahomed, Kassam and Chaboyer, Wendy (2016) ADding negative pRESSure to improve healING (the DRESSING trial): a RCT protocol. BMJ Open, 6 (2). ISSN 2044-6055

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Abstract

Introduction Obese women are more likely to develop a surgical site infection (SSI) following caesarean section (CS) than non-obese women. Negative pressure wound therapy (NPWT) is increasingly being used to reduce SSI with limited evidence for its effectiveness. Objectives To determine the clinical and cost-effectiveness of using NPWT in obese women having elective and semiurgent CS. Methods and analysis A multisite, superiority parallel pragmatic randomised controlled trial with an economic evaluation. Women with a body mass index (BMI) of ≥30, booked for elective and semiurgent CS at 4 Australian acute care hospitals will be targeted. A total of 2090 women will be enrolled. A centralised randomisation service will be used with participants block randomised to either NPWT or standard surgical dressings in a 1:1 ratio, stratified by hospital. The primary outcome is SSI; secondary outcomes include type of SSI, length of stay, readmission, wound complications and health-related quality of life. Economic outcomes include direct healthcare costs and cost-effectiveness, which will be evaluated using incremental cost per quality-adjusted life year gained. Data will be collected at baseline, and participants followed up on the second postoperative day and weekly from the day of surgery for 4 weeks. Outcome assessors will be masked to allocation. The primary statistical analysis will be based on intention-to-treat. Ethics and dissemination Ethics approval has been obtained from the ethics committees of the participating hospitals and universities. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations.

Item Type: Article
Additional Information: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Pure Connector
Date Deposited: 26 Apr 2016 09:00
Last Modified: 22 Jul 2020 00:49
URI: https://ueaeprints.uea.ac.uk/id/eprint/58368
DOI: 10.1136/bmjopen-2015-010287

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