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

Gillespie, Brigid M, Webster, Joan, Ellwood, David, Stapleton, Helen, Whitty, Jennifer A ORCID:, 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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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:
Uncontrolled Keywords: sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Health Economics
Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group
Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
Depositing User: Pure Connector
Date Deposited: 26 Apr 2016 09:00
Last Modified: 22 Oct 2022 01:03
DOI: 10.1136/bmjopen-2015-010287


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