A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Verbal Number Rating Scale (VNRS) - to assess the degree of pain(12 weeks)
- VAS - Visual Analog Scale(12 weeks)
Investigators
Vedran Kovacic
Clinical Professor, Head of Internal Division ICU
University of Split, School of Medicine