Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome; Trigger Finger
• Interventions: Procedure: Wound closure

• Registration Number: NCT03781141
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Absorbable suture	Wound closure	Wound closure with absorbable suture.
Non-absorbable suture	Wound closure	Wound closure with non-absorbable suture.

Primary Outcome Measures

Name	Time	Method
Scar formation with the Patient and Observer Scare Assessment Scale	1 year	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States