Research on multicenter randomized controlled clinical trial of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar
10.3760/cma.j.cn114453-20190915-00272
- VernacularTitle:"类人胶原蛋白疤痕修复硅凝胶"治疗增生期增生性瘢痕多中心随机对照临床研究
- Author:
Jinglong CAI
1
;
Xiaodong CHEN
;
Xueli LI
;
Pan XU
;
Xiaomei CUI
;
Chunyang ZHANG
;
Huajuan WU
;
Yunfei LI
Author Information
1. 蔡景龙医疗美容门诊部，北京蔡景龙瘢痕医学研究中心 100144
- Keywords:
Hypertrophic scar;
Human-like collagen scar repair gel;
Silicone gel
- From:
Chinese Journal of Plastic Surgery
2020;36(4):423-428
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the clinical efficacy of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar.Methods:The clinical effect of smear-like silicone ointment on patients with hypertrophic scars after prolonged injury or 4-6 months after surgery, the difference of curative effects between 3-18 years old juvenile group and 19-45 years old adult group, were analyzed by multicenter randomized controlled clinical study. Among them, 58 cases were treated with human-like collagen scar repair gel, 39 cases in adult group and 19 cases in minor group; 30 cases were using Silicone Gel, 20 cases in adult group and 10 cases in minor group. The differences in scar color, thickness, blood vessel distribution, softness, patient's self-conscious symptoms, clinical efficacy scores and adverse reactions were analyzed before and after application of the products at 4, 8, 12 and 24 weeks.Results:The scores of the two groups before treatment were slightly higher than those of the control group except the softness and thickness score test group ( P<0.05). There was no significant difference in the remaining parameters ( P>0.05). The efficacy scores at the 4th, 8th, 12th and the 24th week after application of the two groups showed that there were significant differences in the therapeutic indicators after treatment for different time ( P<0.05) and age grouping. There was no significant difference between juvenile group and adult group ( P>0.05). There was a statistically significant difference in the time points of different clinical evaluation scores ( P<0.05). There was no interaction between the evaluation time and the experimental control group and age group ( P>0.05); and not affected by group or age grouping ( P>0.05), no adverse reactions occurred in either group. Conclusions:Human-like collagen scar repair gel is safe and effective in the treatment of proliferative hypertrophic scar, and the clinical efficacy is not inferior to Silicone gel.
