BACKGROUND: The human forearm biopsy model can evaluate the effect of novel agents on acute wounds. Bismuth subgallate/borneol (Suile) is a new product cleared by the Food and Drug Administration for treating partial-thickness wounds. Anecdotal reports suggest that Suile may be effective for full-thickness wounds because of its antimicrobial and hemostatic properties.
METHODS: In a randomized, investigator-blinded study, 20 normal healthy volunteers underwent 2 6-mm full-thickness skin punch biopsies on the flexor surface of each forearm (2 wounds per subject). Biopsies were randomly assigned to control (bacitracin) and test article (Suile). Wounds were examined, measured by digital planimetry, and photographed daily until healed. Adverse events and pain levels were monitored. Time-to-complete closure was determined.
RESULTS: Direct quantitative and qualitative comparisons of wound healing were made. The Suile group trended strongly toward more rapid healing (log-rank analysis). Individual subject arm analysis identified which biopsies healed first. Suile-treated biopsies healed more rapidly (P = .03, paired t-test).
CONCLUSION: Although this study was powered to demonstrate equivalence, convincing evidence indicates that Suile is superior to bacitracin in this model. Based on the results, future studies in full-thickness wounds with Suile are warranted. The biopsy model provides these advantages: direct comparison within subjects, rapid study completion, good patient compliance, and experience with products before embarking on larger clinical trials in wounds.
In this randomized, investigator-blinded study of 20 normal healthy volunteers, evidence indicates that Suile is superior to bacitracin in this model. Based on the results, the authors conclude that future studies in full-thickness wounds with Suile are warranted.
Thomas Serena, MD, FACS, is a professor at Gannon University, Erie, PA, and founder and medical director at New Bridge Medical Research and the Penn North Centers for Advanced Wound Care, Warren, PA; Laura K.S. Parnall, MS, CWS, is an independent Research Consultant at Precision Consulting, Missouri City, TX; Carrie Knox, PA-C is a professor at Gannon University, Erie, PA; Julia Vargo, PA-S is a student; Amanda Oliver, PA-S, is a student; Sarah Merry, PA-S, is a student; Andrew Klugh, PA-S is a student; Nicole Bubar, PA-S, is a student; Neil Anderson, PA-S, is a student; Lynn Rieman, PA-S, is a student; Wade Walnoha, PA-S, is a student; Holly Smith, PA-S, is a student; and Samantha Rice, PA-S, is a student at Gannon University, Erie, PA.
Submitted December 5, 2005; accepted in revised form May 3, 2007.