Carpal Tunnel Syndrome BilateralNCT05808855
Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques
A study testing two-component skin adhesive Glubran Tiss 2® and skin stitched with transcutaneous nylon suture in people with Carpal Tunnel Syndrome Bilateral, run by University of Split, School of Medicine at 2 sites in Croatia.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carpal Tunnel Syndrome Bilateral
- What is being tested?
- two-component skin adhesive Glubran Tiss 2® and skin stitched with transcutaneous nylon suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 May 2023to 1 Oct 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
2 sites in 1 country.
Croatia2 sites
Surgery Department, Plastic, Reconstructive and Aesthetic Surgery with Burn Care Division, University Hospital of Split, 21000 Croatia
Split, 21000
University Hospital of Split, 21000 Croatia
Split
About this study
Official title: Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Being tested
- two-component skin adhesive Glubran Tiss 2®, skin stitched with transcutaneous nylon suture
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 2®Procedure or surgery
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.
skin stitched with transcutaneous nylon sutureProcedure 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 adhesive | Experimental | two-component skin adhesive Glubran Tiss 2® Receives: Procedure: two-component skin adhesive Glubran Tiss 2® |
| suture-based wound closure | Active comparator | suture-based wound closure Receives: Procedure: skin stitched with transcutaneous nylon suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
median nerve sensory values measured electromyographic (EMG)
- median nerve latency (msec)
Measured: 2 months
median nerve sensory values measured electromyographic (EMG)
- median nerve sensory conduction velocity (CV) (m/sec)
Measured: 2 months
median nerve sensory values measured electromyographic (EMG)
- median nerve sensory action potential (SAP) amplitude (mcV)
Measured: 2 months
Secondary outcomes (4)
median nerve motoric values measured electromyographic (EMG)
-median nerve motor amplitude (mcV)
Measured: 2 months
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.
Measured: 2 months
median nerve motoric values measured electromyographic (EMG)
-median nerve distal motor latency (DML) (msec)
Measured: 2 months
median nerve motoric values measured electromyographic (EMG)
- median nerve motor conduction velocity (m/sec)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 May 2023
- Primary completion1 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome BilateralStudies 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
- Investigator
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808855
- Sponsor's protocol ID
- 500-03/22-01/42
- Status last verified
- Nov 2023
- First submitted
- 25 Feb 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcomes Following Carpal Tunnel Decompression: a Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
- ClinicalTrials.gov ID
- NCT05808855
- Acronym / sponsor ID
- 500-03/22-01/42
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin adhesive | Experimental | Procedure: two-component skin adhesive Glubran Tiss 2®two-component skin adhesive Glubran Tiss 2® |
| suture-based wound closure | Active comparator | Procedure: skin stitched with transcutaneous nylon suturesuture-based wound closure |
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 2®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. | Procedure or surgery | skin adhesive |
| skin stitched with transcutaneous nylon sutureThe skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0 | Procedure or surgery | suture-based wound closure |
Primary outcome
median nerve sensory values measured electromyographic (EMG)
Time frame: 2 months
- median nerve latency (msec)
median nerve sensory values measured electromyographic (EMG)
Time frame: 2 months
- median nerve sensory conduction velocity (CV) (m/sec)
median nerve sensory values measured electromyographic (EMG)
Time frame: 2 months
- median nerve sensory action potential (SAP) amplitude (mcV)
4 secondary outcomes
median nerve motoric values measured electromyographic (EMG)
Time frame: 2 months
Total EMG severity classification
Time frame: 2 months
median nerve motoric values measured electromyographic (EMG)
Time frame: 2 months
median nerve motoric values measured electromyographic (EMG)
Time frame: 2 months
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 27 Nov 2023.
- Individual participant dataSharing planned: No. Data will be available on request
Related trials for Carpal Tunnel Syndrome Bilateral
Not yet recruiting
Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome
Bilateral Carpal Tunnel Syndrome (Diagnosis), Cardiac Amyloidosis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 stitched with transcutaneous nylon suture in people with Carpal Tunnel Syndrome Bilateral, run by University of Split, School of Medicine at 2 sites 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 27 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 2 sites 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. 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?
median nerve sensory values measured electromyographic (EMG) (time frame: 2 months). The study lists 3 primary outcomes in all. 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 27 Nov 2023.