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: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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.
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia
Split, Croatia
University Hospital of Split, 21000 Croatia
Split, Croatia
median nerve sensory values measured electromyographic (EMG)
\- median nerve latency (msec)
Time frame: 2 months
median nerve sensory values measured electromyographic (EMG)
\- median nerve sensory conduction velocity (CV) (m/sec)
Time frame: 2 months
median nerve sensory values measured electromyographic (EMG)
\- median nerve sensory action potential (SAP) amplitude (mcV)
Time frame: 2 months
median nerve motoric values measured electromyographic (EMG)
-median nerve motor amplitude (mcV)
Time frame: 2 months
Total EMG severity classification
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.
Time frame: 2 months
median nerve motoric values measured electromyographic (EMG)
-median nerve distal motor latency (DML) (msec)
Time frame: 2 months
median nerve motoric values measured electromyographic (EMG)
\- median nerve motor conduction velocity (m/sec)
Time frame: 2 months
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