Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781141
• Other study ID #: 18-004267
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

Description:

The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient greater than or equal to 18 years of age.

• Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release

Exclusion Criteria:

• Any patient identified outside of the proposed study time period.

• Any patient receiving revision surgery

• Patients who have had prior ipsilateral palmar or finger surgery

• Patients with Dupuytren's disease

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Trigger Finger
• Trigger Finger Disorder

Intervention

Procedure:
• Wound closure
Comparison of two wound closures

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar formation with the Patient and Observer Scare Assessment Scale	Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).; The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.	1 year