Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds

An Open-Label Prospective Pilot Study

Sarah W. Manning, MD; David A. Humphrey, MD; William R. Shillinglaw, DO; Eric Crawford; Gaurav Pranami, PhD; Ankit Agarwal, PhD; Michael J. Schurr, MD

Disclosures

Wounds. 2020;32(11):309-318. 

In This Article

Limitations

A limitation of this clinical study is the small sample size (N = 35 wounds; 32 patients). While the majority of the wounds included venous stasis ulcers (n = 19) and DFUs (n = 8), the additional 4 wound types had 1 to 3 patients in the subset groups. This limits generalizability about wound healing efficacy of the matrix in these subgroups and would be a natural area for future clinical studies. Another limitation of the study is that the same clinical investigator did all evaluations during the study. Although he is an experienced wound care physician, wound measurement and evaluation includes a subjective component and introduces the possibility of bias in evaluating wound characteristics and in measurement. In future studies, using additional evaluators would improve interrater reliability. Based on the promising outcomes with the matrix in a variety of chronic wounds in this first prospective clinical study, the authors recommend further evaluation of this novel matrix in future randomized controlled trials in preselected wound types, such as a cohort of only diabetic foot ulcers or burns or surgical wounds.

Comments

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