Prospective Randomized Trial of Monocryl Versus Nylon Suture Closure in Carpal Tunnel Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS) Score - Observer
研究概览
简要总结
The investigators will compare the early postoperative outcome of wound closure technique in carpal tunnel release using Nylon sutures versus subcuticular Monocryl sutures. The investigators plan to randomize patients across three hand surgeons who will perform both techniques, and will survey the patients satisfaction of pain and appearance at 2 and 6 weeks postoperatively.
详细描述
Objectives:
The aim of this study is to determine if there is a significant difference in provider-assessed and patient-assessed outcomes using subcuticular Monocryl vs traditional Nylon sutures for wound closure following open carpal tunnel decompression surgery.
Null hypothesis: There is no significant difference in provider-assessed or patient-assessed outcomes, as measured by the Patient and Observer Scar Assessment Scale (POSAS), between subcuticular Monocryl and traditional nylon wound closure methods after open carpal tunnel surgery.
Alternative hypothesis: Using a running subcuticular Monocryl suture for wound closure following open carpal tunnel release will result in significantly improved POSAS scores in comparison to traditional nylon wound closure
Background:
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)
盲法说明
There is no way to mask the two techniques from the provider or patient since they will see the final result of the technique. The data analysis can be performed in a blinded manner.
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
- •Patients at the University of California, Davis Health Center who are scheduled to undergo surgery for carpal tunnel release will be screened for eligibility for this study.
- •Patients who do not speak English will be included in this study, and will be provided with appropriate translators at all communication points.
排除标准
- •Patients who are not able to follow up at the 2 and 6 week postoperative time points.
- •Patients who have known skin sensitivity to tape or absorbable suture.
- •Those who are unable to give informed consent, individuals who are not yet adults (18 years or older), pregnant women, and prisoners will be excluded from this study.
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS) Score - Observer
时间窗: 6 weeks
As measured by a questionnaire completed by the clinic physician assistant. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
Patient and Observer Scar Assessment Scale (POSAS) Score - Patient
时间窗: 6 weeks
As measured by a questionnaire completed by the patient. The patient scale consists of 6 items scored on a scale ranging from 1 ('no, not at all' or 'no, normal skin') to 10 ('yes, very much' or 'yes, very different'). Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
次要结局
- Patient satisfaction(6 weeks)