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.
This is a prospective, non-inferiority, multi-center, historically controlled, open label study that will evaluate the effects of topical therapy with Sulfamylon® For 5% Topical Solution on autograft healing in subjects with thermal injuries requiring meshed autografts against a similar historic control population in which Sulfamylon® For 5% Topical Solution or mafenide acetate or other mafenide salt forms were not used. Prospective subjects meeting the entrance criteria will receive Sulfamylon® solution as topical antimicrobial treatment on moist dressings following initial meshed autograft procedure (Day 1). Sulfamylon® solution will be used every 6-8 hours, or as needed, to keep the dressing moist. The graft will be evaluated on Days 5-7, Days 12-14 and Days 18-21, unless the subject is discharged, dies, or experiences graft loss / regrafting of the initial meshed autograft prior to Assessment 4 (Days 18-21).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
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.
'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.
University of South Alabama Medical Center
Mobile, Alabama, United States
Arrowhead Regional Medical Center
Redlands, California, United States
Shands Burn Center - Univ. of Florida
Gainesville, Florida, United States
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
All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.
Time frame: Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14
Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population
All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.
Time frame: Days 18 to 21
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
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.
Time frame: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
Time frame: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
Time frame: Days 12-14
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Loyola University Medical Center
Maywood, Illinois, United States
The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
John's Hopkins Burn Center
Baltimore, Maryland, United States
University of Missouri Healthcare - Dept. of Surgery
Columbia, Missouri, United States
Wake Forest University - Department of General Surgery
Winston-Salem, North Carolina, United States
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
Time frame: Days 18-21