Skin Closure With a Fast Absorbable Braided Suture Versus a Non-absorbable Monofilament Suture in Open Carpal Tunnel Release, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient
研究概览
简要总结
The study compares two widely used treatments in closing the wound after open carpal tunnel release surgery: absorbable and non-absorbable sutures. It is conducted as a randomized controlled trial, where the participants are divided into two research groups. The visual outcome of the scar will be evaluated a year after the surgery.
详细描述
Absorbable sutures are more cost efficient and eliminate the need for suture removal both reducing costs and abolishing suture removal pain. We will study the difference in the visual outcome between the two groups. Based on former study the primary hypothesis is that there is no difference between the groups. The patients will evaluate their scars on a VAS-scale one year after the surgery. Secondarily we will focus on pain caused by the two sutures and take the suture removal pain into consideration. We expect therefore the non-absorbable suture to cause more pain in total. The evaluation will happen 2 weeks after the surgery by the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •carpal tunnel syndrome diagnosed with electro near my-graphs
- •symptoms typical of carpal tunnel syndrome
- •referral to carpal tunnel release
- •informed consent signed
- •the ability to receive the virtual questionnaire via email and answer it
- •the ability to understand and answer the Finnish questionnaires
排除标准
- •repeat surgery
- •known allergy to suture materials
- •ongoing systemic steroid treatment
- •ongoing chemotherapy
- •ongoing immunomodulatory treatment
- •past hypertrophic or keloid scars or other severe disturbances in wound healing
- •age under 18, pregnancy or breastfeeding
研究组 & 干预措施
Absorbable Suture
Surgical wounds of this arm will be closed with an absorbable suture.
干预措施: Surgical wound closed with an absorbable suture (Procedure)
Non-absorbable suture
Surgical wounds of this arm will be closed with a non-absorbable suture.
干预措施: Surgical wound closed with a non-absorbable suture (Procedure)
结局指标
主要结局
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient
时间窗: 1 year
The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "the ugliest scar possible" to "the most beautiful scar possible". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.
次要结局
- Adverse events(1 year)
- The Net Promoter Score(1 year)
- Costs(1 year)
- Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor(1 year)
- Pain (VAS) experienced by the patient from the sutures(2 weeks)
- The Boston Carpal Tunnel Questionnaire(1 year)