Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome Bilateral
• Intervention / Treatment: Procedure: two-component skin adhesive Glubran Tiss 2®; Procedure: skin stitched with transcutaneous nylon suture

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vedran Kovacic, prof.dr.; Phone Number: +385915902059; Email: vedran.kovacic.split@gmail.com

Study Locations

• Croatia
  • Split, Croatia, 21000
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: skin adhesive; two-component skin adhesive Glubran Tiss 2®	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.
Active Comparator: suture-based wound closure	Procedure: skin stitched with transcutaneous nylon suture; The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: 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
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

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: April 8, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 500-03/22-01/42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No