Suile™ is a topical ointment formulated for acute and chronic wound treatment. Clinical Trials

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Bismuth Subgallate/Borneal (Suile™) is Superior to Bacitracin in the Human Forearm Biopsy Model for Acute Wound Healing

Percentage of Patients Achieving Complete ClosureBackground
The human forearm biopsy model can evaluate the effect of novel agents on acute wounds. Bismuth Subgallate/Borneol (Suile™) is a new product with FDA permission for the treatment
of partial thickness wounds.

In a randomized, investigator-blinded study, 20 normal healthy volunteers underwent two 6mm
full-thickness skin punch biopsies on the flexor
surface of each forearm (two wounds/subject).
Number of Biopsy Sites Healed First by Treatment GroupBiopsies were randomly assigned to control (bacitracin) or to test article (Suile™). Wounds were examined, measured by digital planimetry, and photographed daily until healed. Adverse events and pain levels were monitored. Time-tocomplete closure was determined.

Direct quantitative and qualitative comparisons of wound healing were observed. Although this study was powered to demonstrate equivalence, the Suile™ group trended strongly towards more rapid healing (log-rank analysis). Individual subject arm analysis examined which treatment healed fi rst. Suile™ treated biopsies healed more rapidly (p=0.03, Pearson’s chi-square test).

Although this study was powered to demonstrate equivalence, there is convincing evidence that Suile™ is superior to Bacitracin in this model. Based on these results, future studies in full thickness wounds with Suile™ are warranted. Also to note, the biopsy model has several advantages: direct comparison within subjects, rapid study completion, good patient compliance, and experience with products prior to embarking on larger clinical trials in wounds.

1Advances in Skin & Wound Care. 20(9):485-492, September 2007.

Additional Clinical Trial Papers

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