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Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

Primary Purpose

Carpal Tunnel Syndrome Bilateral

Status
Not yet recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
two-component skin adhesive Glubran Tiss 2®
skin stitched with transcutaneous nylon suture
Sponsored by
University of Split, School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome Bilateral

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

skin adhesive

suture-based wound closure

Arm Description

two-component skin adhesive Glubran Tiss 2®

suture-based wound closure

Outcomes

Primary Outcome Measures

median nerve sensory values measured electromyographic (EMG)
- median nerve latency (msec)
median nerve sensory values measured electromyographic (EMG)
- median nerve sensory conduction velocity (CV) (m/sec)
median nerve sensory values measured electromyographic (EMG)
- median nerve sensory action potential (SAP) amplitude (mcV)

Secondary Outcome Measures

median nerve motoric values measured electromyographic (EMG)
-median nerve motor amplitude (mcV)
Total EMG severity classification
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.
median nerve motoric values measured electromyographic (EMG)
-median nerve distal motor latency (DML) (msec)
median nerve motoric values measured electromyographic (EMG)
- median nerve motor conduction velocity (m/sec)

Full Information

First Posted
February 25, 2023
Last Updated
April 8, 2023
Sponsor
University of Split, School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05808855
Brief Title
Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques
Official Title
Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Split, School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome Bilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
skin adhesive
Arm Type
Experimental
Arm Description
two-component skin adhesive Glubran Tiss 2®
Arm Title
suture-based wound closure
Arm Type
Active Comparator
Arm Description
suture-based wound closure
Intervention Type
Procedure
Intervention Name(s)
two-component skin adhesive Glubran Tiss 2®
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
skin stitched with transcutaneous nylon suture
Intervention Description
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Primary Outcome Measure Information:
Title
median nerve sensory values measured electromyographic (EMG)
Description
- median nerve latency (msec)
Time Frame
2 months
Title
median nerve sensory values measured electromyographic (EMG)
Description
- median nerve sensory conduction velocity (CV) (m/sec)
Time Frame
2 months
Title
median nerve sensory values measured electromyographic (EMG)
Description
- median nerve sensory action potential (SAP) amplitude (mcV)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
median nerve motoric values measured electromyographic (EMG)
Description
-median nerve motor amplitude (mcV)
Time Frame
2 months
Title
Total EMG severity classification
Description
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.
Time Frame
2 months
Title
median nerve motoric values measured electromyographic (EMG)
Description
-median nerve distal motor latency (DML) (msec)
Time Frame
2 months
Title
median nerve motoric values measured electromyographic (EMG)
Description
- median nerve motor conduction velocity (m/sec)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vedran Kovacic, prof.dr.
Phone
+385915902059
Email
vedran.kovacic.split@gmail.com
Facility Information:
Facility Name
Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
University Hospital of Split, 21000 Croatia
City
Split
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available on request

Learn more about this trial

Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques

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