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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

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. Identifier: NCT00634166
Recruitment Status : Terminated (FDA request as study could not serve as the confirmatory trial as required under Subpart H approval.)
First Posted : March 12, 2008
Results First Posted : September 29, 2014
Last Update Posted : April 14, 2016
Mylan Pharmaceuticals
Information provided by (Responsible Party):
Mylan Bertek Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Burns Drug: Sulfamylon® For 5 % Topical Solution Drug: Topical Antimicrobial/Antifungal Medications Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Historical Control
Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms.
Drug: Topical Antimicrobial/Antifungal Medications
Various topical antimicrobials and antifungals.
Other Name: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.

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).
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00634166

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United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, California
Arrowhead Regional Medical Center
Redlands, California, United States, 92373
United States, Florida
Shands Burn Center - Univ. of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine
Springfield, Illinois, United States, 62794-9653
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
John's Hopkins Burn Center
Baltimore, Maryland, United States, 21224
United States, Missouri
University of Missouri Healthcare - Dept. of Surgery
Columbia, Missouri, United States, 65212
United States, North Carolina
Wake Forest University - Department of General Surgery
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Mylan Pharmaceuticals
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Study Director: Eric Davis, MD Mylan Inc.
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Responsible Party: Mylan Bertek Pharmaceuticals Identifier: NCT00634166    
Other Study ID Numbers: SMS-401
First Posted: March 12, 2008    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: April 14, 2016
Last Verified: April 2013
Keywords provided by Mylan Bertek Pharmaceuticals:
thermal injuries
Burn Patients (Subjects with Thermal Injuries Requiring Meshed Autografts)
Additional relevant MeSH terms:
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Wounds and Injuries
Anti-Bacterial Agents
Amphotericin B
Anti-Infective Agents
Silver Sulfadiazine
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
beta-Lactamase Inhibitors