Different Sutures in Hand Surgery

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Absorbable Chromic gut sutures
* Procedure: Non-absorbable Nylon sutures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |