Carpal Tunnel SyndromeNCT05747989
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
A study testing two-component skin adhesive, Glubran Tiss 2 and skin is stitched with transcutaneous nylon sutures in people with Carpal Tunnel Syndrome, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- two-component skin adhesive, Glubran Tiss 2 and skin is stitched with transcutaneous nylon sutures
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- carpal tunnel syndrome
- weakness of thumb abduction
- with atrophy of the thenar
- median nerve conduction impairment estimated by electromyography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- two-component skin adhesive, Glubran Tiss 2, skin is stitched with transcutaneous nylon sutures
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-component skin adhesive, Glubran Tiss 2Procedure or surgery
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 is stitched with transcutaneous nylon suturesProcedure or surgery
The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
| Study group | Role | What they receive |
|---|---|---|
| skin stitched with two-component skin adhesive | Active comparator | 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. Receives: Procedure: two-component skin adhesive, Glubran Tiss 2 |
| skin stitched with transcutaneous nylon sutures | Placebo comparator | 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 Receives: Procedure: skin is stitched with transcutaneous nylon sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedran Kovacic, University of Split, School of Medicine
- Investigators
- Vedran Kovacic, Prof, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747989
- Sponsor's protocol ID
- 500-03/22-01/41
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
- ClinicalTrials.gov ID
- NCT05747989
- Acronym / sponsor ID
- 500-03/22-01/41
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin stitched with two-component skin adhesive | Active comparator | Procedure: two-component skin adhesive, Glubran Tiss 2After 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 | Placebo comparator | Procedure: skin is stitched with transcutaneous nylon suturesThe 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >18 years
- carpal tunnel syndrome
- weakness of thumb abduction
- with atrophy of the thenar
- median nerve conduction impairment estimated by electromyography
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-component skin adhesive, Glubran Tiss 2After 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 or surgery | skin stitched with two-component skin adhesive |
| skin is stitched with transcutaneous nylon suturesThe skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0 | Procedure or surgery | skin stitched with transcutaneous nylon sutures |
Primary outcome
scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 12 weeks
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
2 secondary outcomes
Verbal Number Rating Scale (VNRS) - to assess the degree of pain
Time frame: 12 weeks
VAS - Visual Analog Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided. Data will be available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vedran Kovacic, Prof principal investigator
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two-component skin adhesive, Glubran Tiss 2 and skin is stitched with transcutaneous nylon sutures in people with Carpal Tunnel Syndrome, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.