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NCT05808855

Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

Completed NA Last updated 27 November 2023
What this trial tests

NA trial testing two-component skin adhesive Glubran Tiss 2® in Carpal Tunnel Syndrome Bilateral in 100 participants. Completed in 1 October 2023.

Timeline
1 May 2023
Primary endpoint
1 August 2023
1 October 2023

Quick facts

Lead sponsorUniversity of Split, School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment100
Start date1 May 2023
Primary completion1 August 2023
Estimated completion1 October 2023
Sites2 locations across Croatia

Drugs / interventions tested

Conditions studied

Sponsor

University of Split, School of Medicine

Who can join

Adults 18 to 99, any sex, with Carpal Tunnel Syndrome Bilateral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Influence of Wound Closure Techniques after Surgical Decompression in Patients with Carpal Tunnel Syndrome on Sleep Disturbance and Life Quality: A Prospective Comparison of Surgical Techniques.
    Sunjic Roguljic V, Roguljic L, Jukic I, Kovacic V. · · 2024 · cited 2× · PMID 38666800 · DOI 10.3390/clinpract14020042
  2. The Influence of the Tissue Adhesive Material as a Surgical Wound-Closure Technique Following Carpal Tunnel Decompression on Neurological and Functional Outcomes: A Single-Center Randomized Controlled Trial.
    Sunjic Roguljic V, Roguljic L, Kovacic V, Bilic I, et al · · 2024 · PMID 38435874 · DOI 10.7759/cureus.53312

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