Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

NCT03781141 | Withdrawn

• 1 other identifier: 18-004267
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome; Trigger Finger

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Absorbable suture

EXPERIMENTAL

Wound closure with absorbable suture.

Procedure: Wound closure

Non-absorbable suture

ACTIVE COMPARATOR

Wound closure with non-absorbable suture.

Procedure: Wound closure

Interventions

Wound closure PROCEDURE

Comparison of two wound closures

Absorbable suture; Non-absorbable suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Peter C Rhee

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment for wound healing
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)