单纯压力衣治疗和联合硅酮治疗预防增生性瘢痕:个体内随机对照试验。

Pressure garment therapy alone and in combination with silicone for the prevention of hypertrophic scarring: randomized controlled trial with intraindividual comparison.

机构信息

Bochum, North Rhine-Westphalia, Germany From the Department of Plastic Surgery, BG University Hospital Bergmannsheil, Ruhr-University Bochum.

出版信息

Plast Reconstr Surg. 2011 Oct;128(4):306e-313e. doi: 10.1097/PRS.0b013e3182268c69.

Abstract

BACKGROUND

Published trials evaluating pressure garment and/or silicone therapy as a treatment for hypertrophic burn scarring are of poor quality and highly susceptible to bias. The authors' aim was to compare the efficacy of pressure garment therapy alone and in combination with silicone gel sheet or spray therapy for the prevention of hypertrophic scarring.

METHODS

The authors conducted an open, single-center, randomized controlled study with intraindividual comparison of study preparations and control to standard treatment. Forty-three consecutive patients with two comparable areas of split-thickness graft burn wounds were recruited into the study, and 38 patients were followed up for 18 months. All patients received compression garments and were randomized to one of two treatment groups: (1) self-drying silicone spray and compression versus compression alone and (2) silicone sheeting and compression versus compression alone. Clinical assessment, measurement of scar redness, height, and photographic documentation of each treated area were performed at different visits over an 18-month follow-up period. Significance was tested using repeated-measures analyses and Wilcoxon paired-sample signed rank tests.

RESULTS

Use of pressure garment therapy alone produced results equivalent to those of combined silicone and pressure garment therapy in the prevention of hypertrophic scars. The efficacy of silicone spray therapy was comparable to that of silicone gel sheet therapy in the prevention of hypertrophic scars. Patients treated with silicone spray had fewer side effects when compared with the silicone sheet group.

CONCLUSION

Multimodal therapy with silicone and pressure garment therapy failed to prevent hypertrophic scars beyond that observed with pressure garment therapy alone.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

摘要

背景

评估压力衣和/或硅酮治疗作为增生性烧伤瘢痕治疗的已发表试验质量较差,且极易受到偏倚影响。作者的目的是比较单独使用压力衣治疗和联合硅酮凝胶片或喷雾治疗预防增生性瘢痕的疗效。

方法

作者进行了一项开放、单中心、随机对照研究,采用个体内比较研究制剂和对照与标准治疗。招募了 43 名连续的、具有两个相似面积的断层皮片移植烧伤创面的患者,并对 38 名患者进行了 18 个月的随访。所有患者均接受压力衣治疗,并随机分为两组中的一组:(1)自干硅酮喷雾和加压与单独加压;(2)硅酮片和加压与单独加压。在 18 个月的随访期间,在不同的就诊时进行临床评估、瘢痕红色、高度的测量以及每个治疗区域的照片记录。使用重复测量分析和 Wilcoxon 配对样本符号秩检验进行显著性检验。

结果

单独使用压力衣治疗的结果与硅酮和压力衣联合治疗预防增生性瘢痕的结果相当。硅酮喷雾治疗预防增生性瘢痕的疗效与硅酮凝胶片治疗相当。与硅酮片组相比,接受硅酮喷雾治疗的患者副作用更少。

结论

硅酮和压力衣联合治疗并不能预防增生性瘢痕,其效果不如单独使用压力衣治疗。

临床问题/证据水平:治疗性,II 级。

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