Defining complete wound closure: Closing the gap in clinical trials and practice

Area of Science:

• Wound healing research
• Clinical trial methodology
• Real-world evidence analysis

Background:

• Current wound healing research lacks standardized definitions and assessment methods.
• Inconsistent methodologies in randomized controlled trials and real-world studies hinder comparative analysis of treatment efficacy.
• Variability in defining 'complete wound closure' complicates evidence synthesis.

Purpose of the Study:

• To investigate current wound closure determination in wound trials and real-world studies.
• To identify limitations in existing wound assessment practices.
• To propose a standardized methodology for defining and assessing wound healing in research.

Main Methods:

• Systematic literature search of PubMed for randomized clinical trials and real-world studies (March 2010-March 2018) using specific keywords.
• Selection of studies with 'complete wound closure' or 'healed wound' as endpoints.
• Extraction of data on wound type, healing definition, assessment method, study duration, and outcomes.

Main Results:

• Analysis of 65 trial articles (7,194 wounds) and 10 real-world articles (901,396 wounds).
• The most common trial definition of healing was 100% epithelialization/closure (40.6%); 81.2% used blinded assessment.
• Real-world studies showed poor definition of healed wounds (33.3%) and lack of blinded assessment (0%).

Conclusions:

• The Food and Drug Administration definition (100% reepithelialization confirmed at two visits 2 weeks apart) is supported.
• Recommends blinded adjudication for wound assessment to enhance reliability.
• Widespread adoption of standard definitions and assessment methods will strengthen wound care research and clinical decision-making.