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

University of Split

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: skin is stitched with transcutaneous nylon sutures; Procedure: two-component skin adhesive, Glubran Tiss 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05747989

500-03/22-01/41

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

98 participants in 2 patient groups, including a placebo group

skin stitched with two-component skin adhesive

Active Comparator group

Description:

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.

Treatment:

Procedure: two-component skin adhesive, Glubran Tiss 2

skin stitched with transcutaneous nylon sutures

Placebo Comparator group

Description:

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

Treatment:

Procedure: skin is stitched with transcutaneous nylon sutures