Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

Study Overview
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Brief Summary
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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
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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: The skin will be stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0. 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.

Official Title
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Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques

Conditions
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Carpal Tunnel Syndrome Bilateral

Intervention / Treatment
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* Procedure: two-component skin adhesive Glubran Tiss 2®
* Procedure: skin stitched with transcutaneous nylon suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skin adhesive<br>two-component skin adhesive Glubran Tiss 2® | Procedure: two-component skin adhesive Glubran Tiss 2®<br>* After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 (Ethicon Inc., USA); a two-component skin adhesive, 0.35 mL of Glubran Tiss 2® (GEM S.r.l., Viareggio, Italy), will be applied in the open wound. Before bandaging, subjects will rest for 20 seconds for a polymerization process.<br>|
| Active Comparator: suture-based wound closure<br>suture-based wound closure | Procedure: skin stitched with transcutaneous nylon suture<br>* The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median nerve sensory values measured electromyographic (EMG) | - median nerve latency (msec) | 2 months | 
| median nerve sensory values measured electromyographic (EMG) | - median nerve sensory conduction velocity (CV) (m/sec) | 2 months | 
| median nerve sensory values measured electromyographic (EMG) | - median nerve sensory action potential (SAP) amplitude (mcV) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median nerve motoric values measured electromyographic (EMG) | -median nerve motor amplitude (mcV) | 2 months | 
| Total EMG severity classification | EMG severity will be classified as: Nerve conduction studies normal Minimaly abnormal the median nerve sensory latency (<3.5 msec) Mild, prolonged median sensory latency (<3.5 msec),but normal median DML Moderate, prolonged median sensory and DML latencies (>4.2 msec) Severe, absence of median SAP and prolonged or absent median DML. | 2 months | 
| median nerve motoric values measured electromyographic (EMG) | -median nerve distal motor latency (DML) (msec) | 2 months | 
| median nerve motoric values measured electromyographic (EMG) | - median nerve motor conduction velocity (m/sec) | 2 months |