Back to resultsWound Closure Study in Carpal Tunnel and Trigger Finger Surgery
Primary Purpose
Carpal Tunnel Syndrome, Trigger Finger
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound closure
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Any patient greater than or equal to 18 years of age.
- Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release
Exclusion Criteria:
- Any patient identified outside of the proposed study time period.
- Any patient receiving revision surgery
- Patients who have had prior ipsilateral palmar or finger surgery
- Patients with Dupuytren's disease
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Absorbable suture
Non-absorbable suture
Arm Description
Wound closure with absorbable suture.
Wound closure with non-absorbable suture.
Outcomes
Primary Outcome Measures
Scar formation with the Patient and Observer Scare Assessment Scale
Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).
The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03781141
Brief Title
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
Official Title
Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.
Detailed Description
The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Blinded assessment for wound healing
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Absorbable suture
Arm Type
Experimental
Arm Description
Wound closure with absorbable suture.
Arm Title
Non-absorbable suture
Arm Type
Active Comparator
Arm Description
Wound closure with non-absorbable suture.
Intervention Type
Procedure
Intervention Name(s)
Wound closure
Intervention Description
Comparison of two wound closures
Primary Outcome Measure Information:
Title
Scar formation with the Patient and Observer Scare Assessment Scale
Description
Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).
The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any patient greater than or equal to 18 years of age.
Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release
Exclusion Criteria:
Any patient identified outside of the proposed study time period.
Any patient receiving revision surgery
Patients who have had prior ipsilateral palmar or finger surgery
Patients with Dupuytren's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Rhee
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Rhee, DO
Phone
507-284-3664
Email
rhee.peter@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
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