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 - Full Text View

Sponsors and Collaborators:	Mylan Bertek Pharmaceuticals Mylan Laboratories
Information provided by:	Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00634166

Purpose

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	Intervention	Phase
Burns	Drug: Sulfamylon® (mafenide acetate) For 5 % Topical Solution	Phase IV

MedlinePlus related topics: Burns

Drug Information available for: Mafenide acetate Mafenide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Historical Control Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)	Drug: Sulfamylon® (mafenide acetate) 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.
Prospective Patients/Active Drug: Experimental 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® (mafenide acetate) 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.

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).

Eligibility

Ages Eligible for Study:	3 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634166

Contacts

Contact: Patrick J Guyton, BS	(304) 554-6693	pj.guyton@mylanlabs.com
Contact: Beverly A Duty	(304) 554-6024	beverly.duty@mylanlabs.com

Locations

United States, California
LAC-USC Medical Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Javona L. Wright 323-226-2615 jwright@surgery.usc.edu
Principal Investigator: Warren Garner, MD
Sub-Investigator: Matthew Reiss, MD, MPH
United States, Georgia
Doctors Hospital of Augusta	Recruiting
Augusta, Georgia, United States, 30909
Contact: Robert F. Mullins, MD 706-364-2966
Contact: Joan Wilson, RN (706) 364-2966
Principal Investigator: Robert F Mullins, MD
Sub-Investigator: S.M. Abu Zaheed Hassan, MD
United States, North Carolina
University of North Carolina Hospitals	Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Mary Kessler, RN, MSN 919-966-3659 mary_kessler@med_unc.edu
Principal Investigator: Bruce A. Cairns, MD
Wake Forest University - Department of General Surgery	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Judy Smith, RN 336-716-6287 jssmith@wfubmc.edu
Contact: Bill Martin, MS 336-716-5414 wmartin@wfubmc.edu
Principal Investigator: James H. Holmes, IV, MD

Sponsors and Collaborators

Mylan Bertek Pharmaceuticals

Mylan Laboratories

Investigators

Study Director:

Eric Davis, MD

Mylan Inc.

More Information

No publications provided

Responsible Party:	MYLAN ( Eric Davis, MD )
Study ID Numbers:	SMS-401
Study First Received:	February 11, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00634166 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:

thermal injuries
burns
Burn Patients (Subjects with Thermal Injuries Requiring Meshed Autografts)

Study placed in the following topic categories:

Burns
Anti-Infective Agents, Local
Mafenide

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Mafenide
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009