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Skin Tear Treatment with Copaifera multijuga Hayne in Polymeric Hydrogel: A Randomized Clinical Trial
Camila Castanho Cardinelli1, Jéssica Teixeira Gâmba Passos1, Valdir Florêncio Veiga-Junior2
1Department of Drugs and Medicines, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.
Abstract:
A double-blind, randomized, and controlled clinical trial with therapeutic intervention was performed at a university hospital in Rio de Janeiro to evaluate whether the addition of Copaifera multijuga Hayne oleoresin to a carboxypolymethylene hydrogel is more effective in skin tear healing than standard treatment. The sample consisted of 84 patients, predominantly men, with a mean age of 67.37 years. These participants were divided into three groups (29 in the intervention group, which received 10% Copaifera oleoresin; 28 in the intervention group, which received 2% Copaifera oleoresin; and 27 in the control group, which received carboxypolymethylene hydrogel). Data were tabulated and analyzed according to the relevant protocols and included only patients who had completed the treatment, while losses were excluded. Weekly follow-ups were conducted to monitor progress. The average healing time differed among the three groups (p > 0.05). There was also a significant difference in healing time between the two intervention groups. Ultimately, CopaibaPolyHy-2 led to significantly faster wound healing than CopaibaPolyHy-10 (p < 0.05). A high increase in granulation and epithelial tissue and a decrease in exudate quantity were observed in the CopaibaPolyHy-2 group. It was not possible to infer whether the wound size reduction differed between the treatments (p > 0.05). At the end of the study, 100% of wounds were healed, with 47,6% healing in week 2 (n = 40). No participants experienced local or serious adverse effects throughout the study period. The current study shows that CopaibaPolyHy-2 is effective, offering a statistically significantly faster healing time, better-quality tissue, and safe treatment for skin tears.
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