ChiCTR1800020207Not yet recruiting治疗新技术临床试验
点阵 CO2 激光治疗挛缩性瘢痕的前瞻性、随机对照临床试验
上海交通大学医学院附属第九人民医院院级基金-临床研究助推计划1 site in 1 country50 target enrollmentStarted: December 24, 2018Last updated:
Trial Snapshot
- Phase
- 治疗新技术临床试验
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 关节活动角度
Study Overview
Brief Summary
通过对点阵 CO2 激光治疗挛缩性瘢痕效果的客观评估，评价该治疗手段的有效性和安全性。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 未说明
Eligibility Criteria
- Ages
- 1 to 70 (—)
- Sex
- Female
Inclusion Criteria
- •烧烫伤、外伤后瘢痕致挛缩性瘢痕，使得附近关节活动角度受限；受影响关节活动范围(Range of motion, ROM)>该关节正常活动范围(ROM)的 1/2；
- •疤痕形成 0.5-10 年；
- •瘢痕无痛痒，红等增生期表现；
- •签署知情同意书，愿意加入本试验，并配合长期随访。
Exclusion Criteria
- •关节活动范围受限因其他原因造成，如关节畸形或肌腱粘连等。
- •瘢痕局部有溃疡、感染等。
- •孕妇或哺乳期妇女。
- •既往有疤痕疙瘩病史。
Arms & Interventions
干预组
点阵 CO2 激光
对照组
红光治疗
Outcomes
Primary Outcomes
关节活动角度
Secondary Outcomes
- 瘢痕硬度
- 瘢痕厚度
- 瘢痕血流情况
- VSS 量表
- UNC 量表
- ISVP 量表
- 瘢痕色素
Investigators
Study Sites (1)
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