title: Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT.
abstract: Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative Pressure Wound Therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT) assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS) and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing) and 46 women received standard care (Comfeel Plus(®) dressing). All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38-1.68); for the number of complications excluding SSI it was 0.98 (95% CI 0.34-2.79). A sample size of 784 (392 per group) would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.
authors.affiliation: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Gold Coast Campus, QLD 4222, Australia. w.chaboyer@griffith.edu.au.
authors.forename: Wendy
authors.initials: W
authors.lastname: Chaboyer
authors.affiliation: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Gold Coast Campus, QLD 4222, Australia. v.anderson@griffith.edu.au.
authors.forename: Vinah
authors.initials: V
authors.lastname: Anderson
authors.affiliation: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Gold Coast Campus, QLD 4222, Australia. joan.webster@health.qld.gov.au.|Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD 4029, Australia. joan.webster@health.qld.gov.au.
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.affiliation: Women's and Newborn Health, Gold Coast University Hospital, Southport, QLD 4215, Australia. anne.sneddon@health.qld.gov.au.
authors.forename: Anne
authors.initials: A
authors.lastname: Sneddon
authors.affiliation: Department of Community Medicine (Biostatistics), Faculty of Medicine, Kuwait University, PO Box 24923, Safat 13110, Kuwait. lthalib@hsc.edu.kw.
authors.forename: Lukman
authors.initials: L
authors.lastname: Thalib
authors.affiliation: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Gold Coast Campus, QLD 4222, Australia. b.gillespie@griffith.edu.au.
authors.forename: Brigid M
authors.initials: BM
authors.lastname: Gillespie
keywords: NPWT; caesarean section; obesity; surgical site infection