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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.
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 neurological outcomes will assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| skin adhesive | Experimental | two-component skin adhesive Glubran Tiss 2® |
|
| suture-based wound closure | Active Comparator | suture-based wound closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two-component skin adhesive Glubran Tiss 2® | Procedure | 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. |
| 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 |
| 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:
|
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Inclusion Criteria: (all of the above)
Exclusion Criteria: (one or more)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia | Split | 21000 | Croatia |
Data will be available on request
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|
| skin stitched with transcutaneous nylon suture | Procedure | The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0 |
|
| 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 |
| University Hospital of Split, 21000 Croatia | Split | Croatia |