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Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Mylan Bertek Pharmaceuticals
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

Tracking Information
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
 (submitted: September 26, 2014)
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
 (submitted: March 11, 2008)
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
 (submitted: September 14, 2022)
  • Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population [ Time Frame: Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 ]
    All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
  • Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population [ Time Frame: Days 18 to 21 ]
    All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
  • Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population [ Time Frame: Days 5-7 ]
    Treatment failure is defined as a change in topical antimicrobial therapy of initial meshed autograft due to suspected infection within the first 7 days or infectious graft loss.
  • Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population [ Time Frame: Days 5-7 ]
    Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
  • Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population [ Time Frame: Days 12-14 ]
    Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
  • Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population [ Time Frame: Days 18-21 ]
    Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
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
Condition  ICMJE Burns
Intervention  ICMJE
  • Drug: Sulfamylon® For 5 % Topical Solution
    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.
    Other Name: mafenide acetate
  • Drug: Topical Antimicrobial/Antifungal Medications
    'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.
    Other Name: Bacitracin; Amphotericin B; others noted below.
Study Arms  ICMJE
  • Historical Control
    Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms. These are considered the Topical Antimicrobial/Antifungal Medications
    Intervention: Drug: Topical Antimicrobial/Antifungal Medications
  • Experimental: Prospective Patients/Active Drug
    Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1). Intervention is Sulfamylon® For 5 % Topical Solution.
    Intervention: Drug: Sulfamylon® For 5 % Topical Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 26, 2014)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Eric Davis, MD Mylan Inc.
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