Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

Carpal Tunnel Syndrome Bilateral Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome Bilateral

• NCT number: NCT05808855
• Study type: Interventional
• Source: University of Split, School of Medicine
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Completion date: October 1, 2023