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Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Plethora of options is in practice: intralesional (IL) injections, silicon sheets, lasers, cryotherapy, radiotherapy and surgery. This study analysed the effect of combination therapy of IL 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) in keloids and HTS's.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional Triamcinolone 5 mg/ml | Drug | Solution containing 5 mg TAC was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe. |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Height | Change in scar height measured in millimeters (mm) using a standardized caliper. | 12 months |
| Vancouver Scar Scale (VSS) Score | Change in scar severity based on the Vancouver Scar Scale, a validated tool assessing vascularity, pigmentation, pliability, and height. Scale Range: 0 (normal skin) to 13 (worst scarring) | 12 months |
| Patient-Reported Pain Score | Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain) | 12 months |
| Patient-Reported Pruritus Score | Self-reported itch severity related to the scar, measured using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no itch) to 10 (worst imaginable itch) | 12 months |
| Patient-Reported Scar Appearance Score | Self-reported perception of scar appearance using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no visible scar) to 10 (worst possible scar appearance) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study was conducted in the Department of Plastic Surgery and Burns, Tribhuvan University Teaching Hospital, Kathmandu, Nepal, from September 2020 to September 2021. Eligible participants included patients presenting with keloids or hypertrophic scars who met the predefined inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Prajjwol Luitel | Institute Of Medicine (IOM), Maharajgunj Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maharajgunj Medical Campus, Institute of Medicine | Kathmandu | Nepal |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| Intralesional 5-fluorouracil | Drug | Solution containing 45 mg 5-FU was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe. |
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |