ADding negative pRESSure to improve healING in obese women undergoing caesarean section (The DRESSING Trial)

Not Applicable

Completed

• Conditions: sing negative pressure wound therapy to prevent surgical site infections in obese women following caesarean section; Using negative pressure wound therapy to prevent surgical site infections in obese women following caesarean section; Public Health - Health service research; Reproductive Health and Childbirth - Childbirth and postnatal care; Surgery - Other surgery

• Registration Number: ACTRN12612000171819
• Lead Sponsor: HMRC Centre of Research Excellence in Nursing Interventions for Hospitalised Patients, Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

(i) informed written informed consent
(ii) recorded Body Mass Index (BMI) of equal to or greater than 30kg/m2 at the first antenatal visit as per the Queensland Maternity
and Neonatal Clinical Guideline 2010
(iii) booked for elective CS surgery (before the commencement of labour)

Exclusion Criteria

(i) Non-English speaking patients without interpreter
(ii) existing infection
(iii) Previous participation in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of surgical site infection (SSI)<br><br>Presence of SSI will be assessed by visual inspection and/or through an aseptically obtained culture. Superficial SSI will be identified by at least one of the following signs; purulent discharge, organisms identified through an aseptically obtained culture, pain/ tenderness/ localised swelling/ heat, or a diagnosis of SSI by the consulting surgeon. A deep incisional SSI will be identified by one of the following; purulent discharge, wound dehiscence, abscess formation, or diagnosis of SSI by the treating surgeon[Daily for the period of hospitalisation and then via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up]

Secondary Outcome Measures

Name	Time	Method
Wound complications including dehiscence, haematoma and seroma will be assessed by visual inspection[Daily for period of hospitalisation and then via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up];self-reported incisional pain in the 2 days after caesarean surgery[daily for two days post surgery];hospital readmissions[at four weeks post surgery];hospital length of stay[at four weeks post surgery];Health-related quality of life (QOL) using SF-12[at baseline i.e. on recruitment at 36 weeks, and via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up]