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The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog & topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 5-FU/Kenalog | Experimental |
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| Group B: Steroid/Antibiotic | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid/Antibiotic (Maxitrol) | Drug | Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of wound healing time | This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery. | 12 months |
| Comparison of infection rate | This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other. | 12 months |
| Comparison of complication rates | Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pain level | This will be assessed through the standardized pain scale. The scale is from 1-5. 1 being no pain and 5 being excruciating pain. A lower pain score suggests better pain management due to improved healing. | 12 months |
| Comparison of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikisha Richards, MD, FACS | Virginia Commonwealth University | Principal Investigator |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| D000900 | Anti-Bacterial Agents |
| C049064 | Maxitrol |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
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| 5-FU/Kenalog | Drug | Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation |
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The use of the burns outcome questionnaire (BOQ) to assess the participant's quality of life throughout the study. This is a 17 question questionnaire with each question scale being from 0 to 4. 0 being not at all and 4 being very much. The scores are then added up for a total score. The range of total scores is from 0-68. A higher score may indicate improved well-being with a specific treatment. |
| 12 months |
| Comparison of cosmetic outcome through the Vancouver scar scale (VSS) | Variables in the VSS include pigmentation, vascularity, pliability and height. The range for the total score is 0-13. A lower VSS scores suggest better scar appearance as well as quality. | 12 months |
| Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) | Variables in the POSAS include color, thickness, relief, pliability, surface area and overall opinion. The range for the total score is 11-44. Lower POSAS scores indicate improved scar aesthetics. | 12 months |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |