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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747989
• Other study ID #: 500-03/22-01/41
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• two-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.
• skin is stitched with transcutaneous nylon sutures
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0

Locations

Country	Name	City	State
Croatia	University Hospital of Split, 21000 Croatia	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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