Different Sutures in Hand Surgery

Not Applicable

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

• Registration Number: NCT03407820
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-01-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2nd random 50% of cohort	Non-absorbable Nylon sutures	Non-absorbable Nylon sutures
1st random 50% of cohort	Absorbable Chromic gut sutures	Absorbable Chromic gut sutures

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction measured on an 11-point ordinal scale	Four weeks after surgery	The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.

Secondary Outcome Measures

Name	Time	Method
Factors associated with wound concerns within one month of surgery	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.
Factors associated with pain intensity (11 point ordinal scale) within one month of surgery	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.
Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery	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.
Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery	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.
Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale	Four weeks after surgery	he scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.

Trial Locations

Locations (3)

Austin Regional Clinic; 🇺🇸 Austin, Texas, United States

HTB Musculoskeletal Institute; 🇺🇸 Austin, Texas, United States

Orthopedic Specialists of Austin; 🇺🇸 Austin, Texas, United States