Back to resultsA Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
Primary Purpose
Carpal Tunnel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
two-component skin adhesive, Glubran Tiss 2
skin is stitched with transcutaneous nylon sutures
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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
Sites / Locations
- University Hospital of Split, 21000 CroatiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
skin stitched with two-component skin adhesive
skin stitched with transcutaneous nylon sutures
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
Full Information
NCT ID
NCT05747989
First Posted
February 16, 2023
Last Updated
February 27, 2023
Sponsor
University of Split, School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05747989
Brief Title
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
Official Title
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
skin stitched with two-component skin adhesive
Arm Type
Active Comparator
Arm Description
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.
Arm Title
skin stitched with transcutaneous nylon sutures
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
two-component skin adhesive, Glubran Tiss 2
Intervention Description
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
Intervention Name(s)
skin is stitched with transcutaneous nylon sutures
Intervention Description
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Primary Outcome Measure Information:
Title
scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Verbal Number Rating Scale (VNRS) - to assess the degree of pain
Description
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
Time Frame
12 weeks
Title
VAS - Visual Analog Scale
Description
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)
Time Frame
12 weeks
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
Phone
+385915902059
Email
vedran.kovacic.split@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedran Kovacic, Prof
Organizational Affiliation
University of Split, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Split, 21000 Croatia
City
Split
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vedran Kovacic, prof
Phone
+385915902059
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be available on request.
Learn more about this trial
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
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