drugset / Trial / NCT00634166
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective is to compare the effectiveness of treatment with Sulfamylon® solution as the initial topical moist dressing over meshed autografts following the initial graft procedure on preventing graft loss in a prospective cohort of subjects versus a historical control group in a non-inferiority trial.
Timeline
- Start
- 2007-09
- Primary completion
- 2013-12
- Completion
- 2014-04
Outcome
Outcome not reported
Stopped: “FDA request as study could not serve as the confirmatory trial.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mafenide | Small molecule | — | Topical |
| Background | Amphotericin B | Unknown | — | — |
| Background | Bacitracin | Unknown | — | — |
| Background | Cefazolin | Small molecule | — | — |
| Background | Fluconazole | Small molecule | — | — |
| Background | Nystatin | Unknown | — | — |
| Background | Piperacillin | Small molecule | — | — |
| Background | Silver Sulfadiazine | Small molecule | — | — |
| Background | Tazobactam | Small molecule | — | — |
| Background | Vancomycin | Other / unclassified | — | — |
Indications
No indication recorded.