Clinical trial NCT03407820: Different Sutures in Hand Surgery
Official title: A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: All Minor Hand Surgery Including
Carpal Tunnel Syndrome
Trigger Finger
Ganglion Cysts
De Quervain Syndrome
Dupuytren Contracture
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Treatment satisfaction measured on an 11-point ordinal scale
timeFrame: Four weeks after surgery
Secondary outcomes:
measure: Factors associated with wound concerns within one month of surgery
timeFrame: Four weeks after surgery
measure: Factors associated with pain intensity (11 point ordinal scale) within one month of surgery
timeFrame: Four weeks after surgery
measure: Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery
timeFrame: Four weeks after surgery
measure: Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery
timeFrame: Four weeks after surgery
measure: Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale
timeFrame: Four weeks after surgery
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: HTB Musculoskeletal Institute
state: Texas
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: David Ring, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: