Original Study Site: University Wound Healing Clinic
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Authors:

Oscar M. Alvarez, Ph.D. and Michael J. Auletta, M.D.

Summary:

This study aimed to compare the effects of two different concentrations of an oak bark extract in cream and ointment bases, a placebo ointment, and an untreated control (Telfa dressing) on partial thickness wounds in 11 healthy male Caucasian volunteers. Four wounds were created on each subject’s thighs, with each wound receiving one of the four treatments. Wounds were evaluated daily for 10 days and again on day 32 for various parameters including epithelialization, granulation, exudate, erythema, edema, induration, reinjury, and pain.Key findings include:

• Re-epithelialization: Agent 3 (Lidacream 4.88%) significantly promoted re-epithelialization from days 3-10 compared to all other treatments, including the Telfa control. Wounds treated with Agent 3 were 75%-100% healed in an average of 6.0 days, while Telfa-treated wounds were less than 25% resurfaced by day 10. Agents 1 (PEG base placebo) and 2 (Bencelok 1.17%) showed similar re-epithelialization rates to Telfa.
• Granulation Tissue: Agent 3 resulted in significantly greater granulation tissue formation from days 3-7. Wounds treated with Agent 3 appeared more vascularized, and no abnormal or excessive granulation was observed.
• Exudate: Agent 3 wounds developed a thick yellow exudate, while Agents 1 and 2 wounds formed a thick semi-soft crust.
• Erythema and Inflammation: Agent 3 led to significantly greater periwound erythema on days 2-5 and more inflammation (edema-cellulitis score) on days 2-4, which subsided by day 5. This prolonged inflammation might contribute to enhanced healing.
• Reinjury: Reinjury upon dressing removal was minimal, but predominantly seen on days 8 and 9 in Telfa-treated wounds. Reinjury was not observed in wounds treated with Agent 3.
• Pain: A significant correlation between pain and Agent 3 was observed on days 2, 3, and 4. Subjects reported a “sharp burning sensation” with initial application of Agent 3, which decreased in duration and severity over time. Mild stinging was noted with Agent 2 on days 4 and 5.

The study concludes that the model is suitable for evaluating dermal repair and epidermal resurfacing, and that Agent 3 demonstrated enhanced healing, potentially due to prolonged inflammation. The small sample size (11 subjects) is noted as a disadvantage, limiting the ability to capture subtle differences.