Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery

NCT ID: NCT03781141

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome Trigger Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinded assessment for wound healing

Study Groups

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Absorbable suture

Wound closure with absorbable suture.

Group Type EXPERIMENTAL

Wound closure

Intervention Type PROCEDURE

Comparison of two wound closures

Non-absorbable suture

Wound closure with non-absorbable suture.

Group Type ACTIVE_COMPARATOR

Wound closure

Intervention Type PROCEDURE

Comparison of two wound closures

Interventions

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Wound closure

Comparison of two wound closures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Peter C. Rhee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter C Rhee

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Peter Rhee, DO

Role: primary

507-284-3664

Related Links

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Other Identifiers

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18-004267

Identifier Type: -

Identifier Source: org_study_id

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