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

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    Open Access Version of Record under the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license (898.8Kb)
    Date
    2016-02-01
    Author
    Gillespie, Brigid M.
    Webster, Joan
    Ellwood, David
    Stapleton, Helen
    Whitty, Jennifer A.
    Thalib, Lukman
    Cullum, Nicky
    Mahomed, Kassam
    Chaboyer, Wendy
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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. TRIAL REGISTRATION NUMBER: ACTRN12615000286549; Pre-results.
    DOI/handle
    http://dx.doi.org/10.1136/bmjopen-2015-010287
    http://hdl.handle.net/10576/4852
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