Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Scar formation with the Patient and Observer Scare Assessment Scale
研究概览
简要总结
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.
详细描述
The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessment for wound healing
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient greater than or equal to 18 years of age.
- •Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release
排除标准
- •Any patient identified outside of the proposed study time period.
- •Any patient receiving revision surgery
- •Patients who have had prior ipsilateral palmar or finger surgery
- •Patients with Dupuytren's disease
研究组 & 干预措施
Absorbable suture
Wound closure with absorbable suture.
干预措施: Wound closure (Procedure)
Non-absorbable suture
Wound closure with non-absorbable suture.
干预措施: Wound closure (Procedure)
结局指标
主要结局
Scar formation with the Patient and Observer Scare Assessment Scale
时间窗: 1 year
Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS). The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
次要结局
未报告次要终点
研究者
Peter C. Rhee
Principal Investigator
Mayo Clinic