Standardised Reporting Outcomes for trials investigating Surgical WOund Complications (ROSWOC): Protocol for the development of a core outcomes set for trials evaluating interventions for the prevention of surgical wound complications.

Abstract

Introduction: Despite advances in surgical technique and wound management surgical wound complications such as surgical site infection and surgical wound dehiscence still pose a considerable global burden. Inconsistencies in measuring and reporting of this phenomenon pervade study designs, analysis and synthesis of the evidence, as such a core outcome set (COS) is required. The Reporting Outcomes for Surgical WOund Complications project (ROSWOC) aims to improve quality of reporting and evidence for surgical site infection and surgical wound dehiscence prevention trials. A core outcome set for trials is required to homogenise outcomes for trials investigating prevention and management of surgical wound complications. Methods: This project aims to develop a core outcome set following established methods; 1) define scope of work, 2) conduct a scoping review, 3) organising facilitated workshops with service users and 4) conduct Delphi surveys, and 5) conduct face-to-face meetings with key stakeholders. Discussion: Following obtaining consensus for the core set, further work will be carried out to describe a core outcomes set. The articulation of an agreed set of core outcomes for trials investigating surgical site infections and surgical wound dehiscence will improve prevention studies into surgical wound complications into the future. Trial registration: The ROSWOC project is registered in the COMET database: (http://www. comet-initiative.org/studies/details/) registered November 2022.