The development of a core outcome set for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds

Charlotte Raepsaet*, Paulo Alves, Breda Cullen, Amit Gefen, José Luis Lázaro-Martínez, Hadar Lev-Tov, Bijan Najafi, Nick Santamaria, Andrew Sharpe, Terry Swanson, Kevin Woo, Dimitri Beeckman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Aim: The aim of this project was to develop a core outcome set (COS) for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds. Methods: The research project followed the Core Outcome Measures in Effectiveness Trials (COMET) initiative and consisted of two phases. The first phase prepared the background and process, while the second phase had three steps: outcome list generation via systematic review and qualitative study, Delphi consensus study, and consensus meeting. The study has been registered in the Core Outcome Measures in Effectiveness Trials database. Results: The systematic review resulted in 82 outcomes and 20 additional outcomes were obtained during the interviews. After refinement, 111 panellists from 23 countries rated a list of 51 outcomes. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set. After the consensus meeting, a patient-reported outcome was added to the core outcome set. Conclusion: The COS for evaluating the effectiveness of bordered foam dressings in treating complex wounds includes 7 outcomes: “ability to stay in place”, “leakage”, “pain”, “dressing related periwound skin changes”, “change in wound size over time”, and “overall satisfaction”. These identified outcomes are correlated with contemporary bioengineering testing and evaluation methods for dressing performance, which underpins the need for a close multidisciplinary collaboration to advance the field of wound dressings. The outcome ‘overall satisfaction’ reflects the impact of complex wounds and their treatment on a patient's daily life. The use of these outcomes is recommended to improve data synthesis and promote evidence-based practice. Future developments in COS development involve creating measurement instruments and relevant endpoints for these outcomes.

Original languageEnglish
Pages (from-to)430-436
Number of pages7
JournalJournal of tissue viability
Volume32
Issue number3
DOIs
Publication statusPublished - 1 Aug 2023

Keywords

  • Bordered foam dressings
  • Complex wound care
  • Complex wounds
  • Core outcome set
  • Treatment

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