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

PHASE4TerminatedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

December 31, 2013

Study Completion Date

April 30, 2014

Conditions
Burns
Interventions
DRUG

Sulfamylon® For 5 % Topical Solution

Sulfamylon® For 5% Topical Solution is 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.

DRUG

Topical Antimicrobial/Antifungal Medications

'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.

Trial Locations (9)

21224

John's Hopkins Burn Center, Baltimore

27157

Wake Forest University - Department of General Surgery, Winston-Salem

32610

Shands Burn Center - Univ. of Florida, Gainesville

36617

University of South Alabama Medical Center, Mobile

60153

Loyola University Medical Center, Maywood

65212

University of Missouri Healthcare - Dept. of Surgery, Columbia

66160

University of Kansas Medical Center, Kansas City

92373

Arrowhead Regional Medical Center, Redlands

62794-9653

The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan Bertek Pharmaceuticals

INDUSTRY

lead

Mylan Inc.

INDUSTRY