- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634166
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
September 14, 2022 updated by: Mylan Inc.
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 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Mobile, Alabama, United States, 36617
- University of South Alabama Medical Center
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California
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Redlands, California, United States, 92373
- Arrowhead Regional Medical Center
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Florida
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Gainesville, Florida, United States, 32610
- Shands Burn Center - Univ. of Florida
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Springfield, Illinois, United States, 62794-9653
- The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, United States, 21224
- John's Hopkins Burn Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Healthcare - Dept. of Surgery
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University - Department of General Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.
Other Names:
|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
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Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14
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Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population
Time Frame: Days 18 to 21
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All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
|
Days 18 to 21
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Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
Time Frame: Days 5-7
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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.
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Days 5-7
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Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Time Frame: Days 5-7
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Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
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Days 5-7
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Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Time Frame: Days 12-14
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Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
|
Days 12-14
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Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Time Frame: Days 18-21
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Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
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Days 18-21
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Eric Davis, MD, Mylan Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 11, 2008
First Submitted That Met QC Criteria
March 11, 2008
First Posted (Estimate)
March 12, 2008
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 14, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Carbonic Anhydrase Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Anti-Bacterial Agents
- Antifungal Agents
- Clotrimazole
- Miconazole
- Anti-Infective Agents
- Amphotericin B
- Bacitracin
- Mafenide
Other Study ID Numbers
- SMS-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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