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

OPEN IN VIEWER

Adam Astrada, DHSc, CNS, RN

Dear Editor,

I am writing in response to the article titled “A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions, ¹ ” published in Advances in Wound Care. I commend the authors for addressing crucial challenges in wound healing trials, particularly the limitations associated with dichotomous outcomes and difficulties in subject recruitment and follow-up. However, I would like to express some concerns and offer additional insights for consideration.

First, the author acknowledges that the study was not powered, and comparisons were not made between randomized cohorts. These deviations from the standard analytical approach in clinical trials raise important questions about the robustness of the study's conclusions. As the randomized controlled trial is a cornerstone in evidence-based medicine, adherence to established analytical principles is paramount for the credibility and generalizability of the findings.

Additionally, the inclusion of a run-in phase, as implemented in the study, poses challenges in subject recruitment and retention. The substantial loss of eligible subjects (47.8%) before the trial even commenced raises concerns about the feasibility of this approach. Streamlining the study design by minimizing such barriers could improve the study's practicality and enhance the likelihood of achieving sufficient statistical power.

Another point of consideration is the use of the laser-assisted wound measurement device for wound dimension measurement. While the device demonstrates validity in measuring wound area, it falls short in assessing wound depth, showing up to a 60% difference compared to ruler measurements. ^2,3 This limitation may introduce potential bias and affect the accuracy of the reported outcomes, questioning the reliability of the study's primary endpoint.

Moreover, the proposed outcome protocol seems to overlook essential wound healing aspects, such as wound bed quality and the presence of tunneling/undermining. These parameters play a crucial role in understanding the overall state of healing and should be considered in the evaluation of wound interventions. I propose the adoption of a wound scoring system tailored to the specific etiology, such as the DMIST Tool for diabetic foot ulcers, which already encompasses wound size and depth measurements along with other pertinent indicators. ⁴

In conclusion, while the study presents valuable insights into wound healing interventions, adherence to conventional analytical standards, careful consideration of measurement tools, and a comprehensive evaluation of wound outcomes are crucial for the advancement of the field. I encourage further discussions on these points and hope that future studies will address these concerns to strengthen the evidence base in wound healing research.

Sincerely,