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临床试验/NCT04339439
NCT04339439终止不适用

Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?

Carilion Clinic2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
47
试验地点
2
主要终点
Patient satisfaction with suture removal

研究概览

简要总结

This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.

详细描述

Surgical wound closure with nonabsorbable stitches necessitates subsequent suture removal, a process that can be uncomfortable for the patient and consume clinic time and resources. Anecdotal evidence suggests that the addition of a vessel loop under the sutures both simplifies suture removal and reduces discomfort. In this study, we propose a prospective, randomized, controlled, superiority trial to assess the impact of a vessel loop wound closure and suture removal for elective carpal tunnel release (CTR). Patients will be prospectively enrolled to one of two groups: closure without a vessel loop or closure with a vessel loop. The primary outcome measure will be patient satisfaction with suture removal. Time for wound closure, time for suture removal, pain with suture removal and other patient reported outcomes will be measured. These data will allow us to determine the benefit of addition of a vessel loop in wound closure.

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
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS).

排除标准

  • Emergency procedures.
  • Revision procedures.
  • Bilateral procedures.
  • Concomitant procedures.
  • Inability to provide informed consent for the study.
  • Non-native English speakers.
  • Allergy to suture material.
  • History of wrist trauma.

结局指标

主要结局

Patient satisfaction with suture removal

时间窗: First postoperative visit (1-2 weeks)

This will be measured on a 100mm visual analog scale.

次要结局

  • Pain with suture removal(First postoperative visit (1-2 weeks).)
  • Time to close the surgical wound(Intraoperatively (0 days))
  • Time to remove suture(First postoperative visit (1-2 weeks).)
  • QuickDASH(6 weeks postoperatively.)
  • Wound complications(6 weeks postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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