- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05747989
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vedran Kovacic, Prof
- Phone Number: +385915902059
- Email: vedran.kovacic.split@gmail.com
Study Locations
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-
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Split, Croatia
- University Hospital of Split, 21000 Croatia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: (all of the above)
- age >18 years
- carpal tunnel syndrome
- weakness of thumb abduction
- with atrophy of the thenar
- median nerve conduction impairment estimated by electromyography
Exclusion Criteria: (one or more)
- threatening haemorrhagic complications (patients with peroral anticoagulation and/or antithrombotic therapy)
- previous wrist trauma or surgery on the wrist region
- another aetiology of neuropathy
- previous allergic reactions (with lidocaine, cyanoacrylate, formaldehyde, tapes, or adhesives)
- personal or family history of keloids or hypertrophic scars
- severe general illness with cachexia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: skin stitched with two-component skin adhesive
After subcutaneous stitches a two-component skin adhesive, Glubran Tiss 2®, will be applied.
G Each subject will receive 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 minutes for a polymerization process.
|
After subcutaneous stitches a two-component skin adhesive, Glubran Tiss 2®, will be applied.
G Each subject will receive 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 minutes for a polymerization process.
|
Placebo Comparator: skin stitched with transcutaneous nylon sutures
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0.
(Optilene® DSMP 19, 3/8 needle, thread size 4/0
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The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 12 weeks
|
scar assessment The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6 |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Number Rating Scale (VNRS) - to assess the degree of pain
Time Frame: 12 weeks
|
degree of pain A Verbal Number Rating Scale (VNRS) was used to assess the degree of pain in the hand before and the day after surgery, as well as at 2, 6, and 12-week intervals during the follow-up period. The VNRS is a verbal self-report instrument with a 0 - 10 numeric rating scale, where 0 represents no pain and 10 represents the most severe pain possible |
12 weeks
|
VAS - Visual Analog Scale
Time Frame: 12 weeks
|
scar assessment VAS (Visual Analog Scale) assessment form was filled out by the patient at the 2, 6, and 12-week intervals. The cosmetic-VAS is a 0-100 scale with "worst scar" written at the left end (0) and "best scar" written at the right end (100) |
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vedran Kovacic, Prof, University of Split, School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500-03/22-01/41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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