title: ADding negative pRESSure to improve healING (the DRESSING trial): a RCT protocol.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To determine the clinical and cost-effectiveness of using NPWT in obese women having elective and semiurgent CS.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ACTRN12615000286549; Pre-results.
authors.affiliation: NHMRC Centre for Research Excellence in Nursing, Centre for Health Practice Innovation (HPI), Menzies Health Institute Qld (MHIQ), Griffith University, Gold Coast, Queensland, Australia.
authors.forename: Brigid M
authors.initials: BM
authors.lastname: Gillespie
authors.affiliation: Research Centre for Clinical Nursing, Royal Brisbane and Women's Hospital and Griffith University, Nathan, Queensland, Australia.
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.affiliation: Department of Obstetrics & Gynaecology, Griffith University School of Medicine and Director of Maternal-Fetal Medicine, Gold Coast University Hospital, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Ellwood
authors.affiliation: Mater Research Institute and The University of Queensland (MRI-UQ), Brisbane, Queensland, Australia.
authors.forename: Helen
authors.initials: H
authors.lastname: Stapleton
authors.affiliation: Department of Health Economics, Pharmacoeconomics & Quality Use of Medicines, School of Pharmacy, University of Queensland, Australia.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Whitty
authors.affiliation: Department of Health Sciences, College of Arts & Science, Qatar University, Qatar.
authors.forename: Lukman
authors.initials: L
authors.lastname: Thalib
authors.affiliation: School of Nursing, Midwifery & Social Work, The University of Manchester, UK.
authors.forename: Nicky
authors.initials: N
authors.lastname: Cullum
authors.affiliation: West Moreton Hospital and Health Service, Ipswich, Queensland, Australia.
authors.forename: Kassam
authors.initials: K
authors.lastname: Mahomed
authors.affiliation: NHMRC Centre for Research Excellence in Nursing, Menzies Health Institute Qld (MHIQ), Griffith University, Gold Coast, Queensland, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Chaboyer
mesh_terms: D001315:Australia; D002585:Cesarean Section; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D054843:Negative-Pressure Wound Therapy / Q000191:economics / Q000379:methods*; D009765:Obesity / Q000150:complications*; D011247:Pregnancy; D012107:Research Design; D013530:Surgical Wound Infection / Q000191:economics / Q000517:prevention & control*; D016896:Treatment Outcome; D014945:Wound Healing
keywords: WOUND MANAGEMENT
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