Carpal Tunnel Syndrome
Conditions
Brief summary
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.
Interventions
PROCEDUREtwo-component skin adhesive, Glubran Tiss 2
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.
PROCEDUREskin is stitched with transcutaneous nylon sutures
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Number Rating Scale (VNRS) - to assess the degree of pain | 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 |
| VAS - Visual Analog Scale | 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) |
Countries
Croatia
Outcome results
None listed