Re: "A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions" by Bull et al.

Abstract

This response critically evaluates the study "A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions," highlighting key concerns and proposing improvements. The study's departure from standard analytical principles, characterized by inadequate power and a lack of cohort comparisons, raises questions about the reliability of its conclusions. Rigorous adherence to established randomized controlled trial methodologies is crucial for valid evidence in wound healing research. Additionally, the inclusion of a run-in phase presents challenges in subject recruitment, resulting in a significant loss of eligible participants. Streamlining study designs to minimize such barriers is imperative for ensuring feasibility and achieving sufficient statistical power. The use of a laser-assisted wound measurement (LAWM) device, though validated for area measurement, overlooks wound depth, introducing potential bias. This limitation underscores the need for meticulous consideration of measurement tools to ensure comprehensive and accurate data collection. The study's proposed outcome protocol neglects crucial wound healing parameters like wound bed quality and tunnelling/undermining. Advocating for customized scoring systems based on wound etiology could address these oversights, enhancing the study's clinical relevance. This critical response emphasizes the importance of methodological rigor and comprehensive outcome assessments in advancing wound healing research. Addressing these concerns will contribute to a more robust evidence base, fostering improved translational outcomes in wound healing interventions. On behalf of Bull et al, Harding & Clements categorically respond to the concerns raised.