A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression

NCT05747989 | Completed

• 1 other identifier: 500-03/22-01/41
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will be 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 outcomes will be assessed during the follow-up period at intervals of 2, 6, and 12 weeks postoperatively. A scar assessment will be using the POSAS (Patient and Observer Scar Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating Scale) will used to assess pain.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)

  scar assessment The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6

  12 weeks

Secondary Outcomes (2)

• Verbal Number Rating Scale (VNRS) - to assess the degree of pain

  12 weeks

• VAS - Visual Analog Scale

  12 weeks

Study Arms (2)

skin stitched with two-component skin adhesive

ACTIVE COMPARATOR

After subcutaneous stitches a two-component skin adhesive, Glubran Tiss 2®, will be applied. G Each subject will receive 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 minutes for a polymerization process.

Procedure: two-component skin adhesive, Glubran Tiss 2

skin stitched with transcutaneous nylon sutures

PLACEBO COMPARATOR

The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0. (Optilene® DSMP 19, 3/8 needle, thread size 4/0

Procedure: skin is stitched with transcutaneous nylon sutures

Interventions

two-component skin adhesive, Glubran Tiss 2 PROCEDURE

After subcutaneous stitches a two-component skin adhesive, Glubran Tiss 2®, will be applied. G Each subject will receive 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 minutes for a polymerization process.

skin stitched with two-component skin adhesive

skin is stitched with transcutaneous nylon sutures PROCEDURE

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

skin stitched with transcutaneous nylon sutures

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 (1)

University Hospital of Split, 21000 Croatia

Split, Croatia

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Vedran Kovacic, Prof

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Internal Division ICU

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 28, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CR (1)