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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808855
• Other study ID #: 500-03/22-01/42
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome Bilateral

Intervention

Procedure:
• two-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.
• skin stitched with transcutaneous nylon suture
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0

Locations

Country	Name	City	State
Croatia	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median nerve sensory values measured electromyographic (EMG)	- median nerve latency (msec)	2 months
Primary	median nerve sensory values measured electromyographic (EMG)	- median nerve sensory conduction velocity (CV) (m/sec)	2 months
Primary	median nerve sensory values measured electromyographic (EMG)	- median nerve sensory action potential (SAP) amplitude (mcV)	2 months
Secondary	median nerve motoric values measured electromyographic (EMG)	-median nerve motor amplitude (mcV)	2 months
Secondary	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
Secondary	median nerve motoric values measured electromyographic (EMG)	-median nerve distal motor latency (DML) (msec)	2 months
Secondary	median nerve motoric values measured electromyographic (EMG)	- median nerve motor conduction velocity (m/sec)	2 months