Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

University of Split

Status: Completed

Conditions: Carpal Tunnel Syndrome Bilateral

Treatments: Procedure: skin stitched with transcutaneous nylon suture; Procedure: two-component skin adhesive Glubran Tiss 2®

Study type: Interventional

Funder types: Other

Identifiers

NCT05808855

500-03/22-01/42

Details and patient eligibility

About

single-centre randomised prospective trial will conducted at the University Hospital of Split in Croatia. The investigators plan to enrol 100 patients, 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 neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.

Full description

All surgical procedures will be performed with a tourniquet and local anaesthesia using 2% lidocaine in the palmar soft tissues and carpal tunnel. For all subjects, the standard carpal canal decompression procedure will began withskin incision in the radial half of the palm, followed by carpal ligament transection and cutting. Following primary closure, two different techniques were used depending on the subject's randomization group:

1. The skin will be stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0.
2. After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 ; a two-component skin adhesive, Glubran Tiss 2® will be applied. Each subject will received 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 seconds for a polymerization process.

The neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.

Enrollment: 100 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

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100 participants in 2 patient groups

skin adhesive

Experimental group

Description:

two-component skin adhesive Glubran Tiss 2®

Treatment:

Procedure: two-component skin adhesive Glubran Tiss 2®

suture-based wound closure

Active Comparator group

Description:

suture-based wound closure

Treatment:

Procedure: skin stitched with transcutaneous nylon suture