Maisonneuve-Rosemont Hospital, Montreal, Que.
Maisonneuve-Rosemont Hospital, Montreal, Que..
Can J Ophthalmol. 2018 Feb;53(1):29-33. doi: 10.1016/j.jcjo.2017.07.017.
To evaluate the effectiveness of a topical silicone gel on scars in patients who had undergone bilateral direct brow lift surgery.
A randomized double-blind clinical trial with a placebo applied to one scar and topical silicone gel (Dermatix Ultra; Valeant Pharmaceuticals, Laval, Que.) used on the other scar for 2 months.
Twelve patients (for a total of 24 surgical scars evaluated) were included in the study.
This study was performed in 2 academic hospitals of the University of Montreal in Montreal, Que. (Maisonneuve-Rosemont Hospital and Notre-Dame Hospital). Inclusion criteria were all bilateral direct brow lift surgeries performed in our hospitals. Exclusion criteria included revision surgery, silicone or latex allergy, and wound infection. Each patient received 2 tubes (1 with silicone gel and 1 with placebo) and applied 1 tube to their right brow scar and the other tube to their left brow scar, following the preassigned instructions. The patient and surgeon were blinded to the nature of the substance that was applied to each scar. At each visit, pictures of both scars were taken, and a questionnaire titled "The Patient and Observer Scar Assessment Scale" was filled out by the patient and the surgeon. A grade ranging from 0 to 10 was given on the multiple criteria in the questionnaire, and the sum of these grades was subsequently used for the data analysis. A lower sum was interpreted as improved scarring. At the end of the study, an independent evaluator graded both scars based on pictures. Follow-up visits were held on day 7, week 6, month 3, and month 6 after surgery. A comparison of the experimental and placebo group was performed with nonparametric tests of Wilcoxon signed rank.
A total of 24 scars of 12 patients were analyzed (based on 4 follow-up visits). General improvement of scars was reported by the patient, the surgeon, and based on pictures. No statistically significant difference was found between the group treated with silicone gel and the group treated with placebo. All tests had a p value ≥0.08.
We did not find a statistically significant difference between scars treated with silicone gel and scars treated with the placebo after direct brow lift surgery.
评估一种局部硅凝胶对接受双侧直接眉提升术患者的疤痕的有效性。
一项随机双盲临床试验，其中一侧疤痕应用安慰剂，另一侧疤痕应用局部硅凝胶（Dermatix Ultra；Valeant Pharmaceuticals，Laval，Que.），持续 2 个月。
12 名患者（共评估 24 例手术疤痕）纳入研究。
该研究在蒙特利尔魁北克省的蒙特利尔大学的 2 所学术医院（Maisonneuve-Rosemont 医院和 Notre-Dame 医院）进行。纳入标准为所有在我们医院进行的双侧直接眉提升手术。排除标准包括修复手术、硅酮或乳胶过敏和伤口感染。每位患者收到 2 管（1 管含硅凝胶，1 管含安慰剂），并按照预定说明将 1 管应用于右侧眉疤痕，将另 1 管应用于左侧眉疤痕。患者和外科医生对应用于每个疤痕的物质的性质均不知情。每次就诊时，都会拍摄两张疤痕照片，并由患者和外科医生填写题为“患者和观察者疤痕评估量表”的问卷。问卷中的多项标准得分为 0 到 10 分，随后将这些分数的总和用于数据分析。较低的总和表示疤痕改善。研究结束时，一名独立评估者根据照片对两个疤痕进行分级。术后第 7、6、3、6 天进行随访。对实验组和安慰剂组进行了非参数 Wilcoxon 符号秩检验比较。
共分析了 12 名患者的 24 处疤痕（基于 4 次随访）。患者、外科医生和基于照片均报告疤痕总体改善。硅凝胶组和安慰剂组之间未发现统计学差异。所有检验的 p 值均≥0.08。
我们未发现直接眉提升术后应用硅凝胶和安慰剂治疗的疤痕之间存在统计学差异。
