Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
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|ClinicalTrials.gov Identifier: NCT00634166|
Recruitment Status : Terminated (FDA request as study could not serve as the confirmatory trial.)
First Posted : March 12, 2008
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: Sulfamylon® For 5 % Topical Solution Drug: Topical Antimicrobial/Antifungal Medications||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Effects of Topical Therapy With Sulfamylon® For 5% Topical Solution on Autograft Healing in Subjects With Thermal Injuries Requiring Meshed Autografts: A Comparison to a Historical Control Group|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||April 2014|
Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms. These are considered the Topical Antimicrobial/Antifungal Medications
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.
Other Name: Bacitracin; Amphotericin B; others noted below.
Experimental: Prospective Patients/Active Drug
Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.
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.
Other Name: mafenide acetate
- Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7. [ Time Frame: The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7. ]
- Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population [ Time Frame: Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 ]All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
- Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population [ Time Frame: Days 18 to 21 ]All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
- Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population [ Time Frame: Days 5-7 ]Treatment failure is defined as a change in topical antimicrobial therapy of initial meshed autograft due to suspected infection within the first 7 days or infectious graft loss.
- Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population [ Time Frame: Days 5-7 ]Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
- Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population [ Time Frame: Days 12-14 ]Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
- Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population [ Time Frame: Days 18-21 ]Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634166
|United States, Alabama|
|University of South Alabama Medical Center|
|Mobile, Alabama, United States, 36617|
|United States, California|
|Arrowhead Regional Medical Center|
|Redlands, California, United States, 92373|
|United States, Florida|
|Shands Burn Center - Univ. of Florida|
|Gainesville, Florida, United States, 32610|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine|
|Springfield, Illinois, United States, 62794-9653|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|John's Hopkins Burn Center|
|Baltimore, Maryland, United States, 21224|
|United States, Missouri|
|University of Missouri Healthcare - Dept. of Surgery|
|Columbia, Missouri, United States, 65212|
|United States, North Carolina|
|Wake Forest University - Department of General Surgery|
|Winston-Salem, North Carolina, United States, 27157|
|Study Director:||Eric Davis, MD||Mylan Inc.|