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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04339439
• Other study ID #: IRB-20-737
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 19, 2022

Study information

• Verified date: February 2023
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 19, 2022
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Satisfaction
• Suture, Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Carilion Institute for Orthopaedics & Neurosciences	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

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