NCT04339439

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Patient Satisfaction
• Suture, Complication

Interventions

Type	Name	Description
DEVICE	Vessel loop (FDA product code FZZ)	The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-11-23
• Completion: 2022-07-19
• First posted: 2020-04-09
• Last updated: 2023-02-14

Locations

1 site across 1 country: United States