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比较氰基丙烯酸酯类与硅凝胶局部治疗预防病理性瘢痕的疗效和安全性的 2 期交叉多中心试验

Phase 2 cross-over multicenter trial on the efficacy and safety of topical cyanoacrylates compared with topical silicone gel in the prevention of pathologic scars.

机构信息

Department of Plastic and Reconstructive Surgery, La Sapienza University of Rome, Viale del Policlinico 155, Rome, Italy.

出版信息

Aesthetic Plast Surg. 2011 Jun;35(3):373-81. doi: 10.1007/s00266-010-9621-8. Epub 2010 Nov 16.

DOI:10.1007/s00266-010-9621-8
PMID:21079955
Abstract

BACKGROUND

Many clinical studies on scar therapy are reported in the literature, but only silicone gel sheeting and corticosteroid injections are supported by accurate prospective controlled studies. This prospective multicenter cross-over phase 2 study tested the effectiveness of a topical cyanoacrylate compared with silicone gel in improving postsurgical scars

METHODS

Patients presenting with symmetric breast scars after augmentation or reduction mammaplasty were enrolled in the study. From the same day as stitch removal, the cyanoacrylate was applied on one side every 3 to 5 days and the silicone gel on the other side twice a day for 3 months. Assessments of patients and external observers using a visual analog scale were recorded at scheduled visits during 1 year, and scars were photographed. Objective evaluations included measurements of scar width, length, and elevation. The statistical significance of objective parameter modifications was analyzed using the Wilcoxon test

RESULTS

Positive effects of both tested products were observed during the scar maturation process, and final scars of good quality were achieved without any major adverse effect. The topical cyanoacrylate proved to be more efficacious in preventing scar widening, and this result was statistically significant

CONCLUSIONS

The tested topical cyanoacrylate had a positive effect on the scar maturation process at least comparable with that of topical silicone gel.

摘要

背景

文献中有许多关于瘢痕治疗的临床研究,但只有硅酮凝胶贴和皮质类固醇注射得到了准确的前瞻性对照研究的支持。这项前瞻性多中心交叉 2 期研究测试了一种局部氰基丙烯酸酯与硅酮凝胶相比在改善手术后瘢痕方面的有效性。

方法

本研究纳入了接受隆乳或缩乳术后出现对称乳房瘢痕的患者。从拆线的那一天起,每隔 3 至 5 天在一侧使用氰基丙烯酸酯,每天两次在另一侧使用硅酮凝胶,持续 3 个月。在 1 年内的预定就诊期间,患者和外部观察者使用视觉模拟量表进行评估,并拍摄瘢痕照片。使用 Wilcoxon 检验分析客观参数变化的统计学意义。

结果

两种测试产品在瘢痕成熟过程中均显示出积极的效果,最终获得了质量良好的瘢痕,没有任何重大不良反应。局部氰基丙烯酸酯在预防瘢痕增宽方面被证明更有效,这一结果具有统计学意义。

结论

测试的局部氰基丙烯酸酯对瘢痕成熟过程有积极影响,至少与局部硅酮凝胶相当。

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