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

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).

Inclusion Criteria:

In order for prospective subjects to be eligible for entry into the study:

- Subjects must have thermal injuries of 20-60% TBSA requiring at least one meshed
autograft on the chest, abdomen, or proximal upper and lower extremities following
surgical excision of the burn injury. Refer to Supplement 20.3.2: Lund Browder charts

- Subjects may be male or female, 3 months of age or older

- Females of childbearing potential must have a negative urine pregnancy test upon
admission and agree to avoid pregnancy throughout the course of the study. Since this
population is hospitalized for the duration of the study, an agreement of sexual
abstinence is appropriate for this trial. Those subjects who do not wish to commit to
sexual abstinence for the duration of this study must agree to avoid pregnancy by
using a medically supervised method of contraception (such as hormonal contraception
in conjunction with a vaginal spermicide or a tubal ligation at least 3 months prior
to study entry)

- Subjects must be willing and able to provide written informed consent. If subjects
are unable to provide written informed consent, then the subject's legally acceptable
representative may provide written informed consent in accordance with the IRB/IEC,
and federal, state and local regulations.

Exclusion Criteria:

Prospective subjects will be excluded from the study for the following reasons:

- Non-thermal burn injuries

- Inhalation injuries resulting in a PaO2 /FIO2 ratio < 300 mmHg on more than one
arterial blood gas in the first 48 hours post-admission

- Females who are currently pregnant or breast feeding, or who intend to become
pregnant during the course of the study

- Subjects with acute renal failure

- Subjects with known systemic allergy to sulfonamides or to sulfur-containing
medication

- Time interval between burn injury and excision and grafting is greater than 7 days

- Grafting procedures that are conducted and/or evaluated on an outpatient basis

- Inability to use a meshed autograft as part of the initial grafting procedure

- Inability to use SS5% as the only initial prophylactic topical antimicrobial therapy
on meshed autografts

- Thermal burn injuries less than 20% or greater than 60% TBSA

- Subjects who are participating in any other clinical studies involving any
investigational product, or who have participated in such a study within the previous
30 days

- Subjects with known glucose-6-phosphate dehydrogenase deficiency