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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome

• Registration Number: NCT05747989
• Lead Sponsor: University of Split, School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-02-28
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospital of Split, 21000 Croatia; 🇭🇷 Split, Croatia