Status:
TERMINATED
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
Lead Sponsor:
Mylan Inc.
Collaborating Sponsors:
Mylan Bertek Pharmaceuticals
Conditions:
Burns
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief 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 preve...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00634166
Start Date
September 1 2007
End Date
April 1 2014
Last Update
September 29 2022
Active Locations (9)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
2
Arrowhead Regional Medical Center
Redlands, California, United States, 92373
3
Shands Burn Center - Univ. of Florida
Gainesville, Florida, United States, 32610
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153