Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
Condition: Burns
Intervention: Sulfamylon® For 5 % Topical Solution; Topical Antimicrobial/Antifungal Medications
Intervention description: 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.
Intervention MeSH terms: Anti-Infective Agents; Amphotericin B; Clotrimazole; Miconazole; Bacitracin; Mafenide; Anti-Bacterial Agents; Antifungal Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: thermal injuries; burns; Burn Patients

Summary:

      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.
    

Eligibility criteria:

        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