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

IRB Number

12-525

ClinicalTrials.gov Identifier

NCT00634166

Trial Status

Open for Enrollment
Phase Post Market

Why is this study being done?

The purpose of this study is to compare the effectiveness of treatment with Sulfamylon® solution as the initial topical moist dressing over meshed autografts on preventing graft loss. A prospective cohort of subjects will be compared to a historical control group in a non-inferiority trial.

Who is eligible to participate?

Males and females, ages 3 months and older, with 20-60% total body surface area burns who are admitted to the Memorial Medical Center Regional Burn Center may be eligible.

What is involved?

Prospective participants will receive Sulfamylon® solution as topical antimicrobial treatment on moist dressings following the initial meshed autograft procedure. Assessments will be completed at various intervals during hospitalization, which will be compared to similar assessments of previously hospitalized burn patients who did not receive Sulfamylon®.

How long is the study?

The study may take up to 3 weeks or less if discharged before 3 weeks.

Who can I contact for additional information?

Please contact Jennifer Koechle, MPH, at (217) 545-7014 or email jkoechle@siumed.edu

Who is the Principal Investigator of this study?

Michael W. Neumeister, MD

Where is the trial located?

Springfield, Illinois