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

Carilion Clinic

Status: Terminated

Conditions: Patient Satisfaction; Suture, Complication

Treatments: Device: Vessel loop (FDA product code FZZ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04339439

IRB-20-737

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Closure without vessel loop

No Intervention group

Description:

These patients will receive standard of care closure of the carpal tunnel release incision.

Closure with vessel loop

Experimental group

Description:

These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures.

Treatment:

Device: Vessel loop (FDA product code FZZ)