Nylon Versus Chromic Gut Sutures for Minor Hand Surgery

NCT03407820 | Completed

• 1 other identifier: 2017-11-0021
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.

Conditions

All Minor Hand Surgery Including; Carpal Tunnel Syndrome; Trigger Finger; Ganglion Cysts; De Quervain Syndrome; Dupuytren Contracture

Outcome Measures

Primary Outcomes (1)

• Treatment satisfaction measured on an 11-point ordinal scale

  The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.

  Four weeks after surgery

Secondary Outcomes (5)

• Factors associated with wound concerns within one month of surgery

  Four weeks after surgery

• Factors associated with pain intensity (11 point ordinal scale) within one month of surgery

  Four weeks after surgery

• Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery

  Four weeks after surgery

• Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery

  Four weeks after surgery

• Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale

  Four weeks after surgery

Study Arms (2)

1st random 50% of cohort

ACTIVE COMPARATOR

Absorbable Chromic gut sutures

Procedure: Absorbable Chromic gut sutures

2nd random 50% of cohort

ACTIVE COMPARATOR

Non-absorbable Nylon sutures

Procedure: Non-absorbable Nylon sutures

Interventions

Absorbable Chromic gut sutures PROCEDURE

In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received absorbable Chromic sutures are treated recording to the standard protocol and they are advised that they can start to gently rub the scab and suture line to encourage the sutures to fall off starting 10-14 days postoperatively.

1st random 50% of cohort

Non-absorbable Nylon sutures PROCEDURE

In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received Nylon sutures are treated recording to the standard protocol and sutures are removed after the usual time (10-14 days) of the received procedure.

2nd random 50% of cohort

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:
• Carpal tunnel release
• Trigger finger release
• Ganglion excision
• Excisional biopsy
• De Quervain release
• Dupuytren fasciectomy
• Any other minor hand surgery
• Patients aged 18-89
• Able to provide informed consent
• Able to understand English or Spanish to complete questionnaires
• Patients who have an email-address or phone number (needed for follow-up)
• UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Orthopaedic Specialists of Austin.
• Available for follow-up contact after 4 weeks

You may not qualify if:

• Patients not able to give informed consent
• Patients using corticosteroids
• Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
• Patients known to be allergic to suture materials
• Revision procedures

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (3)

Austin Regional Clinic

Austin, Texas, 78705, United States

Location

HTB Musculoskeletal Institute

Austin, Texas, 78712, United States

Location

Orthopedic Specialists of Austin

Austin, Texas, 78751, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Trigger Finger Disorder; Ganglion Cysts; Dupuytren Contracture

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; Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Contracture

Study Officials

• David Ring, MD PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both patient and surgeon will be blinded until just before the start of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Comprehensive Care. Professor of Surgery and Psychiatry

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: January 31, 2018
• Primary Completion: May 30, 2020
• Study Completion: August 1, 2022
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)