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

NCT00634166 | Terminated Phase 4 Results

• 1 other identifier: SMS-401
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 9

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.

Conditions

Burns

Keywords

thermal injuries; burns; Burn Patients

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.

  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 Outcomes (6)

• Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population

  Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14

• Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population

  Days 18 to 21

• Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population

  Days 5-7

• Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population

  Days 5-7

• Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population

  Days 12-14

Study Arms (2)

Historical Control

OTHER

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

Drug: Topical Antimicrobial/Antifungal Medications

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). Intervention is Sulfamylon® For 5 % Topical Solution.

Drug: Sulfamylon® For 5 % Topical Solution

Interventions

Sulfamylon® For 5 % Topical Solution 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.

Also known as: mafenide acetate

Prospective Patients/Active Drug

Topical Antimicrobial/Antifungal Medications DRUG

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

Also known as: Bacitracin; Amphotericin B; others noted below.

Historical Control

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan Bertek Pharmaceuticals: collaborator

Study Sites (9)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Arrowhead Regional Medical Center

Redlands, California, 92373, United States

Location

Shands Burn Center - Univ. of Florida

Gainesville, Florida, 32610, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

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

Springfield, Illinois, 62794-9653, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

John's Hopkins Burn Center

Baltimore, Maryland, 21224, United States

Location

University of Missouri Healthcare - Dept. of Surgery

Columbia, Missouri, 65212, United States

Location

Wake Forest University - Department of General Surgery

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Mafenide; Solutions; Anti-Infective Agents; Bacitracin; Amphotericin B

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Polyketides; Lactones

Limitations and Caveats

The study was terminated on 17 June 2013 due to the recommendation and request by the FDA to design a superiority clinical study to satisfy the sponsor's post marketing study commitment for SS5%.

Results Point of Contact

• Title: Eric Davis, M.D.
• Organization: Mylan Pharmaceuticals Inc.

eric.davis@mylan.com

304.554.6503

Study Officials

• Eric Davis, MD

  Mylan Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: March 12, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: September 29, 2022
• Results First Posted: September 29, 2014

Record last verified: 2022-09

Locations

US (9)