Cardinelli Camila Castanho, Passos Jéssica Teixeira Gâmba, Veiga-Junior Valdir Florêncio, de Oliveira Beatriz Guitton Renaud Baptista, Santos Elisabete Pereira Dos, Neto Guilherme Guilhermino, Di Piero Karina Chamma, de Freitas Zaida Maria Faria
Department of Drugs and Medicines, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.
Department of Chemical Engineering, Military Institute of Engineering, Rio de Janeiro 22290-270, Brazil.
Pharmaceuticals (Basel). 2024 Dec 15;17(12):1691. doi: 10.3390/ph17121691.
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 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 ( > 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 ( < 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 ( > 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.
在里约热内卢的一家大学医院进行了一项双盲、随机、对照的治疗干预临床试验，以评估在羧基聚亚甲基水凝胶中添加海尼油树脂在皮肤撕裂愈合方面是否比标准治疗更有效。样本包括84名患者，主要为男性，平均年龄67.37岁。这些参与者被分为三组（干预组29人，接受10%的苦配巴油树脂；干预组28人，接受2%的苦配巴油树脂；对照组27人，接受羧基聚亚甲基水凝胶）。数据根据相关方案进行列表和分析，仅纳入完成治疗的患者，排除失访者。每周进行随访以监测进展。三组的平均愈合时间不同（P>0.05）。两个干预组之间的愈合时间也存在显著差异。最终，CopaibaPolyHy - 2导致伤口愈合明显快于CopaibaPolyHy - 10（P<0.05）。在CopaibaPolyHy - 2组中观察到肉芽组织和上皮组织大量增加，渗出物数量减少。无法推断不同治疗之间伤口大小的减小是否存在差异（P>0.05）。在研究结束时，100%的伤口愈合，47.6%在第2周愈合（n = 40）。在整个研究期间，没有参与者出现局部或严重的不良反应。当前研究表明，CopaibaPolyHy - 2是有效的，在统计学上提供了显著更快的愈合时间、质量更好的组织以及对皮肤撕裂的安全治疗。
