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

NCT ID: NCT00634166

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-04-30

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).

Conditions

Burns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Topical Antimicrobial/Antifungal Medications

Intervention Type: DRUG

'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.

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.

Group Type: EXPERIMENTAL

Sulfamylon® For 5 % Topical Solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

mafenide acetate; Bacitracin; Amphotericin B; others noted below.

Eligibility 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

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Bertek Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Davis, MD

Role: STUDY_DIRECTOR

Mylan Inc.

Locations

University of South Alabama Medical Center

Mobile, Alabama, United States

Arrowhead Regional Medical Center

Redlands, California, United States

Shands Burn Center - Univ. of Florida

Gainesville, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine

Springfield, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

John's Hopkins Burn Center

Baltimore, Maryland, United States

University of Missouri Healthcare - Dept. of Surgery

Columbia, Missouri, United States

Wake Forest University - Department of General Surgery

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

SMS-401

Identifier Type: -

Identifier Source: org_study_id