SWHSI-COS
Research type
Research Study
Full title
Surgical Wounds Healing by Secondary Intention: Development of a Core Outcome Set
IRAS ID
327080
Contact name
Misha Sidapra
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Duration of Study in the UK
2 years, 11 months, 5 days
Research summary
Following an operation, most patients will have their wounds closed up with stitches or staples, however in some patients, this is not possible or advisable to do. In this group, surgical wounds are monitored while they are allowed to heal from the base up. This is often referred to as a surgical wound healing by secondary intention (SWHSI).
Living with a SWHSI can have a serious impact on the lives of those patients. Researchers and clinicians are working to improve treatments and services in this group, but the lack of a standardised approach to this work has meant that research studies often can’t be easily combined with other studies to optimise the power of the work.
This study aims to make research into new treatments easier, cheaper and more useful by building an essential list of outcomes for all researchers to use when designing trials for SWHSIs in the future – called a ‘Core Outcomes Set’. This will mean that research completed by different groups in different places is more easily comparable. It can also be more easily combined for meta-analysis.
Our methods will comprise of a systematic review of the literature to identify the outcomes that have already been used in clinical trials, and qualitative interviews with patients and clinical experts to identify any gaps. This is followed by a three-round Delphi survey to rank the importance of each outcome.Finally, we bring the results of the survey to a “consensus meeting”. This is attended by representatives of all the groups that are involved: patients and carers, doctors and nurses, researchers and others. At that meeting, the results of the survey are discussed and a final decision is made to decide which outcomes should be included in the core outcomes set.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0253
Date of REC Opinion
6 Dec 2023
REC opinion
Further Information Favourable Opinion