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

NCT04339439 | Terminated DMC

• 1 other identifier: IRB-20-737
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Satisfaction; Suture, Complication

Keywords

suture; vessel loop; suture removal; satisfaction; carpal tunnel release

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with suture removal

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

  First postoperative visit (1-2 weeks)

Secondary Outcomes (5)

• 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).

• Wound complications

  6 weeks postoperatively

• QuickDASH

  6 weeks postoperatively.

Study Arms (2)

Closure without vessel loop

NO INTERVENTION

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

Closure with vessel loop

EXPERIMENTAL

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

Device: Vessel loop (FDA product code FZZ)

Interventions

Vessel loop (FDA product code FZZ) DEVICE

The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.

Closure with vessel loop

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Institute for Orthopaedics & Neurosciences

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Peter J Apel, MD, PhD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who agree to participate will be enrolled and randomized to one of two study groups: * Group 1: Incision closure without a vessel loop. * Group 2: Incision closure with a vessel loop.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: August 1, 2020
• Primary Completion: November 23, 2021
• Study Completion: July 19, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)