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
This study is currently recruiting participants.
Verified April 2012 by Mylan Bertek Pharmaceuticals
Sponsor:
Mylan Bertek Pharmaceuticals
Collaborator:
Mylan Pharmaceuticals
Information provided by (Responsible Party):
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00634166
First received: February 11, 2008
Last updated: April 18, 2012
Last verified: April 2012
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Burns
Drug Information available for:
Mafenide acetate
U.S. FDA Resources
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: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (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.
|
|
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).
|
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, Alabama | |
| University of South Alabama Medical Center | Recruiting |
| Mobile, Alabama, United States, 36617 | |
| Contact: Cathy Blache, RN 251-471-7988 | |
| Contact: Kelley Taylor, RN 251-471-7988 | |
| Principal Investigator: Arnold Luterman, MD | |
| Sub-Investigator: Karen Frye, MD | |
| Sub-Investigator: Lynn Dyess, MD | |
| United States, California | |
| Arrowhead Regional Medical Center | Recruiting |
| Redlands, California, United States, 92373 | |
| Contact: Jennifer Hardy, PAC 909-580-2172 | |
| Principal Investigator: Victor C Joe, MD | |
| United States, Florida | |
| Shands Burn Center - Univ. of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Tera Thigpin 352-265-0125 tera.thigpin@surgery.ufl.edu | |
| Principal Investigator: David W Mozingo, MD | |
| United States, Illinois | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Marcia M Halerz, RN 708-327-2457 mhalerz@lumc.edu | |
| Principal Investigator: Richard L. Gamelli, MD | |
| The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine | Recruiting |
| Springfield, Illinois, United States, 62794-9653 | |
| Contact: Carisa M Cooney, MPH, CCRP 217-545-7014 ccooney@siumed.edu | |
| Principal Investigator: Michael W. Neumeister, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Richard A. Korentager, MD 913-588-7661 | |
| Principal Investigator: William Dougherty, MD | |
| United States, Maryland | |
| John's Hopkins Burn Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Stephen Milner, MD 410-550-0886 | |
| Contact: Dene Noppenberger 410-550-4895 | |
| Principal Investigator: Stephen M. Milner, MD | |
| United States, Missouri | |
| University of Missouri Healthcare - Dept. of Surgery | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Contact: Patsy A Wies, RN 573-882-4387 wiesp@health.missouri.edu | |
| Principal Investigator: Nicholas A Meyer, MD | |
| Sub-Investigator: Boyd E. Terry, MD | |
| United States, North Carolina | |
| 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 Pharmaceuticals
Investigators
| Study Director: | Eric Davis, MD | Mylan Inc. |
More Information
No publications provided
| Responsible Party: | Mylan Bertek Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00634166 History of Changes |
| Other Study ID Numbers: | SMS-401 |
| Study First Received: | February 11, 2008 |
| Last Updated: | April 18, 2012 |
| 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) |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Mafenide Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013