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

Condition(s) targeted: Burns

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Mylan Bertek Pharmaceuticals

Official(s) and/or principal investigator(s):
Eric Davis, MD, Study Director, Affiliation: Mylan Inc.

Overall contact:
Patrick J Guyton, BS, Phone: (304) 554-6693, Email: pj.guyton@mylanlabs.com

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.

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

Primary outcome: 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.

Secondary outcome: The secondary objective is to examine the reasons for graft loss in subjects treated with Sulfamylon® solution versus historical controls.

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).

Minimum age: 3 Months. Maximum age: N/A. Gender(s): Both.

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

Patrick J Guyton, BS, Phone: (304) 554-6693, Email: pj.guyton@mylanlabs.com

LAC-USC Medical Center, Los Angeles, California 90033, United States; Recruiting
Javona L. Wright, Phone: 323-226-2615, Email: jwright@surgery.usc.edu
Warren Garner, MD, Principal Investigator
Matthew Reiss, MD, MPH, Sub-Investigator

Doctors Hospital of Augusta, Augusta, Georgia 30909, United States; Recruiting
Robert F. Mullins, MD, Phone: 706-364-2966
Joan Wilson, RN, Phone: (706) 364-2966
Robert F Mullins, MD, Principal Investigator
S.M. Abu Zaheed Hassan, MD, Sub-Investigator

University of North Carolina Hospitals, Chapel Hill, North Carolina 27514, United States; Recruiting
Mary Kessler, RN, MSN, Phone: 919-966-3659, Email: mary_kessler@med_unc.edu
Bruce A. Cairns, MD, Principal Investigator

Wake Forest University - Department of General Surgery, Winston-Salem, North Carolina 27157, United States; Recruiting
Judy Smith, RN, Phone: 336-716-6287, Email: jssmith@wfubmc.edu
Bill Martin, MS, Phone: 336-716-5414, Email: wmartin@wfubmc.edu
James H. Holmes, IV, MD, Principal Investigator

Starting date: September 2007
Ending date: September 2009
Last updated: March 11, 2008