ProNounCE: Version 1.0
Research type
Research Study
Full title
Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial
IRAS ID
260172
Contact name
Eman Alkizwini
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Wound infections after operations on the bowel affect up to 30% of patients and can have significant short- and long-term effects. Special dressings have been developed to try to minimise these infections, but it is not clear if these dressings actually work. The aim of this study is to compare the wound-related outcomes associated with using three different dressings after specific operations. We will be comparing conservative dressings, involving a simple peel and stick dressing with padding, and two types of dressings that use a small amount of suction on the wound. These will be the Prevena peel and place dressing and a locally-made layered suction dressing (closed incision VAC – ciVAC). We will compare the rates of wound infections, number of dressings used, length of stay in hospital and costs associated with each dressing used. We will also look at changes in quality of life measures, the wider costs associated with having a wound, any readmissions into hospital or other complications within the first three months after patient’s operations.
This study will be carried out in multiple hospitals within the UK and South Africa. We will be including patients who have had open operations on their bowel (not keyhole) and have had their wounds closed at the end of the operation. Each hospital taking part in the study will use each of the three dressings being compared, one at a time, for a set amount of time. The order that each hospital uses the dressings in will be determined at random. Data will be collected on outcomes for the first three months after patient’s operations.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0535
Date of REC Opinion
31 Oct 2019
REC opinion
Favourable Opinion