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This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and Keloids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split Keloid - first side | Experimental |
| |
| Split Keloid - second side | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermomechanical system with corticosteroids | Device | The device in this study using Novoxel - Tixel® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thickness by caliper (mm) - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids | cthickness by caliper in mm. | 6 months |
| Vancouver Scar Scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids | Vancouver Scar Scale between 0 to 13 | 6 months |
| Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids | Measuring Antera Elevation Volume in mm3 | 6 months |
| Patient satisfaction quartile scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids | Patient satisfaction quartile scale from 0 - 100% | 6 months |
| Physician evaluation quartile score - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids | Physician evaluation quartile score from 0-100% | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect | 6 months | |
| Side effect of Triamcinolone acetonide injection | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Woraphong Manuskiatti, M.D. | Contact | +6624197000 | 4333 | woraphong.man@mahidol.ac.th |
| Chadakan Yan, M.D. | Contact | +66882334090 | chadakanyan4090@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Siriraj Hospital, Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
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| corticosteroid injection | Other | corticosteroid injection using TA 10mg/ml |
|
| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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