Different Sutures in Hand Surgery

• ClinicalTrials.gov Identifier: NCT03407820
• Recruitment Status: Unknown
• First Posted: January 23, 2018
• Last Update Posted: December 26, 2019
• Sponsor: University of Texas at Austin
• Information provided by (Responsible Party): David Ring, University of Texas at Austin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
All Minor Hand Surgery Including; Carpal Tunnel Syndrome; Trigger Finger; Ganglion Cysts; De Quervain Syndrome; Dupuytren Contracture	Procedure: Absorbable Chromic gut sutures; Procedure: Non-absorbable Nylon sutures	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Both patient and surgeon will be blinded until just before the start of the procedure.
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery
• Actual Study Start Date: January 31, 2018
• Estimated Primary Completion Date: May 30, 2020
• Estimated Study Completion Date: May 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Texas

Austin Regional Clinic

Austin, Texas, United States, 78705

HTB Musculoskeletal Institute

Austin, Texas, United States, 78712

Orthopedic Specialists of Austin

Austin, Texas, United States, 78751

Sponsors and Collaborators

University of Texas at Austin

Investigators

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

More Information

• Responsible Party: David Ring, Associate Dean for Comprehensive Care. Professor of Surgery and Psychiatry, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03407820
• Other Study ID Numbers: 2017-11-0021
• First Posted: January 23, 2018
• Last Update Posted: December 26, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ganglion Cysts; Dupuytren Contracture; Contracture; Trigger Finger Disorder; Carpal Tunnel Syndrome; Syndrome; Disease; Pathologic Processes; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Entrapment; Tendinopathy; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue