Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

NCT05808855 | Completed

• 1 other identifier: 500-03/22-01/42
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome Bilateral

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• median nerve motoric values measured electromyographic (EMG)

  2 months

• Total EMG severity classification

  2 months

• median nerve motoric values measured electromyographic (EMG)

  2 months

• median nerve motoric values measured electromyographic (EMG)

  2 months

Study Arms (2)

skin adhesive

EXPERIMENTAL

two-component skin adhesive Glubran Tiss 2®

Procedure: two-component skin adhesive Glubran Tiss 2®

suture-based wound closure

ACTIVE COMPARATOR

suture-based wound closure

Procedure: skin stitched with transcutaneous nylon suture

Interventions

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.

skin adhesive

skin stitched with transcutaneous nylon suture PROCEDURE

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

suture-based wound closure

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years
• carpal tunnel syndrome
• weakness of thumb abduction
• with atrophy of the thenar
• median nerve conduction impairment estimated by electromyography

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (2)

Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia

Split, 21000, Croatia

Location

University Hospital of Split, 21000 Croatia

Split, Croatia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor of Medicine

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2)