Carpal Tunnel Syndrome Bilateral
Conditions
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.
Interventions
PROCEDUREtwo-component skin adhesive Glubran Tiss 2®
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.
PROCEDUREskin stitched with transcutaneous nylon suture
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| median nerve sensory values measured electromyographic (EMG) | 2 months | \- median nerve latency (msec) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| median nerve motoric values measured electromyographic (EMG) | 2 months | -median nerve motor amplitude (mcV) |
| Total EMG severity classification | 2 months | EMG severity will be classified as: 1. Nerve conduction studies normal 2. Minimaly abnormal the median nerve sensory latency (\<3.5 msec) 3. Mild, prolonged median sensory latency (\<3.5 msec),but normal median DML 4. Moderate, prolonged median sensory and DML latencies (\>4.2 msec) 5. Severe, absence of median SAP and prolonged or absent median DML. |
Countries
Croatia
Outcome results
None listed