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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two-component skin adhesive, Glubran Tiss 2 | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: (all of the above)
Exclusion Criteria: (one or more)
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| Name | Affiliation | Role |
|---|---|---|
| Vedran Kovacic, Prof | University of Split, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Split, 21000 Croatia | Split | Croatia |
Data will be available on request.
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|
| skin is stitched with transcutaneous nylon sutures | Procedure | The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0 |
|
| 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) | 12 weeks |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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