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

Not Applicable

Terminated

• Conditions: Patient Satisfaction; Suture, Complication
• Interventions: Device: Vessel loop (FDA product code FZZ)

• Registration Number: NCT04339439
• Lead Sponsor: Carilion Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-09
• Study Start: 2020-08-01
• Primary Completion: 2021-11-23
• Study Completion: 2022-07-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closure with vessel loop	Vessel loop (FDA product code FZZ)	These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with suture removal	First postoperative visit (1-2 weeks)	This will be measured on a 100mm visual analog scale.

Secondary Outcome Measures

Name	Time	Method
Pain with suture removal	First postoperative visit (1-2 weeks).	This will be measured on a 100mm visual analog scale.
Time to close the surgical wound	Intraoperatively (0 days)	The time that it takes the provider to close the wound intraoperatively.
Time to remove suture	First postoperative visit (1-2 weeks).	The time that it takes the provider to remove sutures postoperatively.
QuickDASH	6 weeks postoperatively.	A validate instrument assessing disability of the arm, shoulder, and hand.
Wound complications	6 weeks postoperatively	Any wound complications will be noted from the clinical record.

Trial Locations

Locations (1)

Carilion Institute for Orthopaedics & Neurosciences; 🇺🇸 Roanoke, Virginia, United States