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AuthorGillespie, Brigid M.
AuthorWebster, Joan
AuthorEllwood, David
AuthorStapleton, Helen
AuthorWhitty, Jennifer A.
AuthorThalib, Lukman
AuthorCullum, Nicky
AuthorMahomed, Kassam
AuthorChaboyer, Wendy
Available date2016-10-10T07:19:30Z
Publication Date2016-02-01
Publication NameBMJ Openen_US
Identifierhttp://dx.doi.org/10.1136/bmjopen-2015-010287
CitationADding negative pRESSure to improve healING (the DRESSING trial): a RCT protocol Brigid M Gillespie, Joan Webster, David Ellwood, Helen Stapleton, Jennifer A Whitty, Lukman Thalib, Nicky Cullum, Kassam Mahomed, Wendy Chaboyer BMJ Open 2016;6:2 e010287
ISSN2044-6055
URIhttp://hdl.handle.net/10576/4852
AbstractINTRODUCTION: 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.
SponsorAustralian National Health & Medical Research Project Grant (APP1081026)
Languageen
PublisherBMJ Publishing Group Limited
SubjectWOUND MANAGEMENT
SubjectObesity
SubjectCaesarean section
TitleADding negative pRESSure to improve healING (the DRESSING trial): a RCT protocol.
TypeArticle
Issue Number2
Volume Number6


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