Different Sutures in Hand Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03407820
• Other study ID #: 2017-11-0021
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2019
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Austin Regional Clinic	Austin	Texas
United States	HTB Musculoskeletal Institute	Austin	Texas
United States	Orthopedic Specialists of Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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