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Completed

NCT Number: NCT05808855

Neurological Outcomes Following Carpal Tunnel 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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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:

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

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 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

Procedure

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

Primary outcomes

  1. median nerve sensory values measured electromyographic (EMG)

    Time frame: 2 months

    • median nerve latency (msec)
  2. median nerve sensory values measured electromyographic (EMG)

    Time frame: 2 months

    • median nerve sensory conduction velocity (CV) (m/sec)
  3. median nerve sensory values measured electromyographic (EMG)

    Time frame: 2 months

    • median nerve sensory action potential (SAP) amplitude (mcV)

Secondary outcomes

  1. median nerve motoric values measured electromyographic (EMG)

    Time frame: 2 months

    -median nerve motor amplitude (mcV)

  2. Total EMG severity classification

    Time frame: 2 months

    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.
  3. median nerve motoric values measured electromyographic (EMG)

    Time frame: 2 months

    -median nerve distal motor latency (DML) (msec)

  4. median nerve motoric values measured electromyographic (EMG)

    Time frame: 2 months

    • median nerve motor conduction velocity (m/sec)

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Nov 27, 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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