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NCT Number: NCT03407820

Nylon Versus Chromic Gut Sutures for Minor Hand Surgery

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.

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Key information

Conditions

All Minor Hand Surgery Including Carpal Tunnel Syndrome Connective Tissue Diseases Contracture Cumulative Trauma Disorders Cysts De Quervain Syndrome Dupuytren Contracture Fibroma Ganglion Cysts Median Neuropathy Mononeuropathies Mucinoses Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin and Connective Tissue Diseases Sprains and Strains Tendinopathy Tendon Entrapment Trigger Finger Trigger Finger Disorder Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austin Regional Clinic, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Treatment satisfaction measured on an 11-point ordinal scale

    Time frame: Four weeks after surgery

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

Secondary outcomes

  1. Factors associated with wound concerns within one month of surgery

    Time frame: Four weeks after surgery

    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. Wound concerns will be assessed by number of contacts with questions for wound concerns.

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

    Time frame: Four weeks after surgery

    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher pain intensity.

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

    Time frame: Four weeks after surgery

    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. PROMIS-UE PF scores are reported as T-scores with a mean of 50 and SD of 10, with higher scores representing higher levels of physical function.

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

    Time frame: Four weeks after surgery

    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher scar satisfaction.

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

    Time frame: Four weeks after surgery

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

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Nylon and Chromic Gut Sutures After Minor Hand Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jan 23, 2018
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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