Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
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ClinicalTrials.gov Identifier: NCT00634166 |
Recruitment Status :
Terminated
(FDA request as study could not serve as the confirmatory trial.)
First Posted : March 12, 2008
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2022
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Sponsor:
Mylan Inc.
Collaborator:
Mylan Bertek Pharmaceuticals
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )
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Tracking Information | ||||
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First Submitted Date ICMJE | February 11, 2008 | |||
First Posted Date ICMJE | March 12, 2008 | |||
Results First Submitted Date ICMJE | September 22, 2014 | |||
Results First Posted Date ICMJE | September 29, 2014 | |||
Last Update Posted Date | September 29, 2022 | |||
Study Start Date ICMJE | September 2007 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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. ] | |||
Original Primary Outcome Measures ICMJE |
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. [ 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. ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
The secondary objective is to examine the reasons for graft loss in subjects treated with Sulfamylon® solution versus historical controls. [ Time Frame: Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 and Days 18-21; Treatment Failure at Days 5-7; and Infectious Graft Loss at Days 5-7, Days 12-14 and Days 18-21. ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group | |||
Official Title ICMJE | 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 | |||
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 preventing graft loss in a prospective cohort of subjects versus a historical control group in a non-inferiority trial. | |||
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 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Burns | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
220 | |||
Original Estimated Enrollment ICMJE |
141 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: In order for prospective subjects to be eligible for entry into the study:
Exclusion Criteria: Prospective subjects will be excluded from the study for the following reasons:
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Sex/Gender ICMJE |
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Ages ICMJE | 3 Months and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | India | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00634166 | |||
Other Study ID Numbers ICMJE | SMS-401 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Viatris Inc. ( Mylan Inc. ) | |||
Original Responsible Party | Eric Davis, MD, MYLAN | |||
Current Study Sponsor ICMJE | Mylan Inc. | |||
Original Study Sponsor ICMJE | Mylan Bertek Pharmaceuticals | |||
Collaborators ICMJE | Mylan Bertek Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | Viatris Inc. | |||
Verification Date | September 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |