drugset / Trial / NCT00634166

Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group

NCT00634166

Phase 4 Terminated 220 enrolled Mylan Inc. Mylan Bertek Pharmaceuticals · collab
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

Drugs

EvaluationDrugModalityDoseRoute
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.