A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression

Study Overview
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Brief Summary
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Participants will be randomly assigned to suture-based wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The outcomes will be assessed during the follow-up period at intervals of 2, 6, and 12 weeks postoperatively. A scar assessment will be using the POSAS (Patient and Observer Scar Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating Scale) will used to assess pain.

Official Title
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A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: two-component skin adhesive, Glubran Tiss 2
* Procedure: skin is stitched with transcutaneous nylon sutures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: skin stitched with two-component skin adhesive<br>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. | Procedure: two-component skin adhesive, Glubran Tiss 2<br>* 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.<br>|
| Placebo Comparator: skin stitched with transcutaneous nylon sutures<br>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 | Procedure: skin is stitched with transcutaneous nylon sutures<br>* The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) | 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 | 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 | 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 |