Abstract | 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.
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Authors | Thomas Serena, Laura K S Parnall, Carrie Knox, Julia Vargo, Amanda Oliver, Sarah Merry, Andrew Klugh, Nicole Bubar, Neil Anderson, Lynn Rieman, Wade Walnoha, Holly Smith, Samantha Rice |
Journal | Advances in skin & wound care
(Adv Skin Wound Care)
Vol. 20
Issue 9 Pt 1
Pg. 485-92
(Sep 2007)
ISSN: 1527-7941 [Print] United States |
PMID | 17762217
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Camphanes
- Carbonates
- Ointments
- isoborneol
- bismuth subcarbonate
- Bismuth
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Topics |
- Administration, Topical
- Adult
- Biopsy, Needle
- Bismuth
(pharmacology)
- Camphanes
(pharmacology)
- Carbonates
- Female
- Forearm
- Humans
- Male
- Ointments
- Single-Blind Method
- Skin
(drug effects, injuries)
- Wound Healing
(drug effects)
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