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Completed

NCT Number: NCT05747989

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Split, 21000 Croatia

Split, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 is stitched with transcutaneous nylon sutures

Procedure

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

Primary outcomes

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

    Time frame: 12 weeks

    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

Secondary outcomes

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

    Time frame: 12 weeks

    degree of pain

    A Verbal Number Rating Scale (VNRS) was used to assess the degree of pain in the hand before and the day after surgery, as well as at 2, 6, and 12-week intervals during the follow-up period. The VNRS is a verbal self-report instrument with a 0 - 10 numeric rating scale, where 0 represents no pain and 10 represents the most severe pain possible

  2. VAS - Visual Analog Scale

    Time frame: 12 weeks

    scar assessment

    VAS (Visual Analog Scale) assessment form was filled out by the patient at the 2, 6, and 12-week intervals. The cosmetic-VAS is a 0-100 scale with "worst scar" written at the left end (0) and "best scar" written at the right end (100)

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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