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CompletedNCT03407820Updated Jul 31, 2025

Nylon Versus Chromic Gut Sutures for Minor Hand Surgery

An interventional study of Absorbable Chromic gut sutures and Non-absorbable Nylon sutures in All Minor Hand Surgery Including, Carpal Tunnel Syndrome and Trigger Finger, sponsored by University of Texas at Austin. Completed at 3 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • All Minor Hand Surgery Including
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Ganglion Cysts
  • De Quervain Syndrome
  • Dupuytren Contracture
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
112 participants (actual)

Study arms

  • Active comparator
    1st random 50% of cohort

    Absorbable Chromic gut sutures

    Procedure: Absorbable Chromic gut sutures

  • Active comparator
    2nd random 50% of cohort

    Non-absorbable Nylon sutures

    Procedure: Non-absorbable Nylon sutures

Interventions

  • ProcedureAbsorbable Chromic gut sutures

    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.

  • ProcedureNon-absorbable Nylon sutures

    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.

05

What researchers measure

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.

    Time frame: Four weeks after surgery

Secondary outcomes

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

    Time frame: Four weeks after surgery

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

    Time frame: Four weeks after surgery

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

    Time frame: Four weeks after surgery

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

    Time frame: Four weeks after surgery

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

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

    Time frame: Four weeks after surgery

06

Study locations

3 sites
  • Austin Regional Clinic
    Austin, Texas 78705, United States
  • HTB Musculoskeletal Institute
    Austin, Texas 78712, United States
  • Orthopedic Specialists of Austin
    Austin, Texas 78751, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407820
Lead sponsor
University of Texas at Austin
Responsible party
David Ring (Associate Dean for Comprehensive Care. Professor of Surgery and Psychiatry, University of Texas at Austin) — Principal investigator
First posted
Jan 23, 2018
Start date
Jan 31, 2018
Primary completion
May 30, 2020
Completion
Aug 1, 2022
Last update
Jul 31, 2025

Study contacts

David Ring, MD PhD
principal investigator · University of Texas at Austin

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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