Different Sutures in Hand Surgery

A Randomized Controlled Trial: Nylon Versus Chromic Sutures in 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.

Study Overview

• Status: Unknown
• Conditions: Ganglion Cysts; Carpal Tunnel Syndrome; Trigger Finger; Dupuytren Contracture; All Minor Hand Surgery Including; De Quervain Syndrome
• Intervention / Treatment: Procedure: Absorbable Chromic gut sutures; Procedure: Non-absorbable Nylon sutures

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1st random 50% of cohort; Absorbable Chromic gut sutures	Procedure: Absorbable 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.
Active Comparator: 2nd random 50% of cohort; Non-absorbable Nylon sutures	Procedure: Non-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks after surgery
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.	Four weeks after surgery
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.	Four weeks after surgery
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.	Four weeks after surgery
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.	Four weeks after surgery

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: David Ring, MD PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Wounds and Injuries; Disease; Cysts; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Mucinoses; Neoplasms, Connective Tissue; Tendinopathy; Neoplasms, Fibrous Tissue; Tendon Entrapment; Fibroma; Syndrome; Carpal Tunnel Syndrome; Ganglion Cysts; Contracture; Trigger Finger Disorder; Dupuytren Contracture
• Other Study ID Numbers: 2017-11-0021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No