A systematic review of outcome measures utilised in clinical research studies for surgical wounds healing by secondary intention: A study protocol

Background Management of surgical wounds healing by secondary intention is a costly and complex issue for patients, clinicians and researchers alike. They are often slow to heal, can require a high level of healthcare resource use, and constitute a large proportion of the £8.3 billion annual spend on wound care in the United Kingdom. Evidence-based innovations in care are desperately needed, but heterogeneity in research design and delivery is an obvious source of inefficiency and delay. Core Outcome Sets are evidence-based, consensually-derived minimum reporting guidelines that enable consistency in outcome reporting across studies in a research area. This systematic review identifies the primary and supporting outcomes currently and historically reported in trials in surgical wounds healing by secondary intention. Methods A structured, staged search of Medline, EMBASE, CINAHL, the Cochrane database and trial registries will be completed. Results will be screened to identify quantitative and qualitative studies in the population of participants with surgical wounds healing by secondary intention, and reported outcomes will be extracted verbatim from included studies, as well as definition, study type and method of outcome measurement, to produce a map of the current landscape of outcomes considered most relevant and salient in this research area. Discussion This descriptive systematic review will identify the historical and current outcomes reported in clinical studies about surgical wounds healing by secondary intention. Together with direct stakeholder input, this will form the basis of the consensus-building process in the development of a core outcome set in surgical wounds healing by secondary intention in the SWHSI-COS Study.