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

NCT ID: NCT05747989

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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skin stitched with two-component skin adhesive

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.

Group Type ACTIVE_COMPARATOR

two-component skin adhesive, Glubran Tiss 2

Intervention Type 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 transcutaneous nylon sutures

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

Group Type PLACEBO_COMPARATOR

skin is stitched with transcutaneous nylon sutures

Intervention Type PROCEDURE

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

Interventions

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two-component skin adhesive, Glubran Tiss 2

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.

Intervention Type PROCEDURE

skin is stitched with transcutaneous nylon sutures

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age \>18 years
* carpal tunnel syndrome
* weakness of thumb abduction
* with atrophy of the thenar
* median nerve conduction impairment estimated by electromyography

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Split, School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Vedran Kovacic

Clinical Professor, Head of Internal Division ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vedran Kovacic, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Split, School of Medicine

Locations

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University Hospital of Split, 21000 Croatia

Split, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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500-03/22-01/41

Identifier Type: -

Identifier Source: org_study_id