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Mafenide

Generic Name
Mafenide
Brand Names
Sulfamylon
Drug Type
Small Molecule
Chemical Formula
C7H10N2O2S
CAS Number
138-39-6
Unique Ingredient Identifier
58447S8P4L
Background

Mafenide is a sulfonamide-type antimicrobial agent used to treat severe burns. It acts by reducing the bacterial population present in the burn tissue and promotes healing of deep burns. In 1998, mafenide acetate was approved under the FDA’s accelerated approval regulations. In November 2022, the use of mafenide acetate (powder for 5% topical solution) was withdrawn by the FDA due to an unresolved confirmatory study required to fulfill the accelerated approval requirements.

Indication

Indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Phase 2
Terminated
Conditions
Burn
Interventions
First Posted Date
2008-05-12
Last Posted Date
2023-06-22
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
98
Registration Number
NCT00675922
Locations
🇺🇸

University of Texas Medical Branch, Galveston, Texas, United States

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

Phase 4
Terminated
Conditions
Burns
Interventions
Drug: Topical Antimicrobial/Antifungal Medications
First Posted Date
2008-03-12
Last Posted Date
2022-09-29
Lead Sponsor
Mylan Inc.
Target Recruit Count
220
Registration Number
NCT00634166
Locations
🇺🇸

University of South Alabama Medical Center, Mobile, Alabama, United States

🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

🇺🇸

John's Hopkins Burn Center, Baltimore, Maryland, United States

and more 6 locations

Vashe Wound Therapy Study

Not Applicable
Completed
Conditions
Burns
Interventions
First Posted Date
2008-01-04
Last Posted Date
2012-09-14
Lead Sponsor
Valleywise Health
Target Recruit Count
23
Registration Number
NCT00586729
Locations
🇺🇸

Maricopa Integrated Health System, Phoenix, Arizona, United States

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