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

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

Study Overview

• Status: Terminated
• Conditions: Patient Satisfaction; Suture, Complication
• Intervention / Treatment: Device: Vessel loop (FDA product code FZZ)

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter J Apel, MD, PhD; Phone Number: (540) 855-7183; Email: pjapel@carilionclinic.org
• Study Contact Backup: Name: Sarah Smith, MSN; Phone Number: (540) 512-1056; Email: sfsmith@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Institute for Orthopaedics & Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Closure without vessel loop; These patients will receive standard of care closure of the carpal tunnel release incision.
EXPERIMENTAL: Closure with vessel loop; 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); The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carilion Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): November 23, 2021
• Study Completion (ACTUAL): July 19, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 9, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: satisfaction; suture; vessel loop; suture removal; carpal tunnel release
• Other Study ID Numbers: IRB-20-737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD are to be shared with other researchers. Only aggregate data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No