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

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: two-component skin adhesive, Glubran Tiss 2; Procedure: skin is stitched with transcutaneous nylon sutures

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia
    • University Hospital of Split, 21000 Croatia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Placebo Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Number Rating Scale (VNRS) - to assess the degree of pain	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	12 weeks
VAS - Visual Analog Scale	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)	12 weeks

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine
• Investigators: Principal Investigator: Vedran Kovacic, Prof, University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 500-03/22-01/41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No