Clinical trial NCT05808855: Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques
Official title: Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome Bilateral
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: median nerve sensory values measured electromyographic (EMG)
timeFrame: 2 months
measure: median nerve sensory values measured electromyographic (EMG)
timeFrame: 2 months
measure: median nerve sensory values measured electromyographic (EMG)
timeFrame: 2 months
Secondary outcomes:
measure: median nerve motoric values measured electromyographic (EMG)
timeFrame: 2 months
measure: Total EMG severity classification
timeFrame: 2 months
measure: median nerve motoric values measured electromyographic (EMG)
timeFrame: 2 months
measure: median nerve motoric values measured electromyographic (EMG)
timeFrame: 2 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia
city: Split
country: Croatia
facility: University Hospital of Split, 21000 Croatia
Study officials:
References: