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| Name | Class |
|---|---|
| LAC+USC Medical Center | OTHER |
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Randomized, double-blind, placebo controlled, prospective, split-scar study of severe burn victims with autologous skin transplants. 9 months intervention time and 3 months follow-up, photographic scar documentation, self-and observer questionnaires throughout
Interventional, comparative, prospective, evaluator blinded, randomized, placebo- controlled, split-scar model longitudinal study including 28-31 healthy study participants (See Section 6 Statistical Considerations) with both the original burn scar area that is the skin graft recipient area and the skin graft donor site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Graft Burn Patients Experimental Site | Experimental | Both placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. |
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| Skin Graft Burn Patients Placebo Site | Placebo Comparator | Both placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synochi Scar Spray Cosmetic | Other | Application of the cosmetic on each skin graft in a blinded fashion in different sections for a 9 month duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| improvement of cosmetic appearance Synochi Scar Spray versus Placebo | Section I of the Patient Scar Assessment Questionnaire (9 questions) minimum 9 points, maximum 36 with higher ratings indicating less improvement of cosmetic appearance | 12 month study time frame |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the safety of Synochi Scar Spray | Safety of Synochi Scar Spray as indicated by absence of adverse events and/or severe adverse events | 12 month study time frame |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Gillenwater, MD | Contact | (323)409-7750 | Justin.Gillenwater@med.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Justin Gillenwater, MD | USC School of Medicine | Principal Investigator |
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blinded
| Synochi Scar Spray Placebo | Other | Application of the placebo on each skin graft in a blinded fashion in different sections for a 9 month duration. |
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