BurnsPhase 4NCT00634166
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
A Phase 4 study testing Sulfamylon® For 5 % Topical Solution and Topical Antimicrobial/Antifungal Medications in people with Burns, run by Mylan Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Burns
- What is being tested?
- Sulfamylon® For 5 % Topical Solution and Topical Antimicrobial/Antifungal Medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2007to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
John's Hopkins Burn Center
Baltimore, Maryland, 21224
University of Missouri Healthcare - Dept. of Surgery
Columbia, Missouri, 65212
Shands Burn Center - Univ. of Florida
Gainesville, Florida, 32610
University of Kansas Medical Center
Kansas City, Kansas, 66160
Loyola University Medical Center
Maywood, Illinois, 60153
University of South Alabama Medical Center
Mobile, Alabama, 36617
Arrowhead Regional Medical Center
Redlands, California, 92373
The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine
Springfield, Illinois, 62794-9653
Wake Forest University - Department of General Surgery
Winston-Salem, North Carolina, 27157
About this 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
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.
Read the 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
- Being tested
- Sulfamylon® For 5 % Topical Solution, Topical Antimicrobial/Antifungal Medications
- Keywords
- thermal injuries, burns, Burn Patients
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfamylon® For 5 % Topical SolutionDrug
Also called mafenide acetate
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.
Topical Antimicrobial/Antifungal MedicationsDrug
Also called Bacitracin; Amphotericin B; others noted below.
'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Sulfamylon® For 5 % Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.
Measured: 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
All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
Measured: 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
All cause graft loss is defined as graft adhesion of < 85% for the initial meshed autograft procedure.
Measured: Days 18 to 21
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
Treatment failure is defined as a change in topical antimicrobial therapy of initial meshed autograft due to suspected infection within the first 7 days or infectious graft loss.
Measured: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Measured: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Measured: Days 12-14
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Graft adhesion of < 85% for the initial meshed autograft procedure due to infection.
Measured: Days 18-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2013
- Study completionApr 2014
Why it stopped: FDA request as study could not serve as the confirmatory trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Bertek Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Eric Davis, MD, Study director, Mylan Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634166
- Sponsor's protocol ID
- SMS-401
- Status last verified
- Sep 2022
- First submitted
- 11 Feb 2008
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00634166
- Acronym / sponsor ID
- SMS-401
- Conditions
- Burns
- Keywords
- thermal injuries, burns, Burn Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA request as study could not serve as the confirmatory trial.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mylan Bertek Pharmaceuticals
- Study start
- Sep 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical Control | Other | Drug: Topical Antimicrobial/Antifungal MedicationsTreated 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 |
| Prospective Patients/Active Drug | Experimental | Drug: Sulfamylon® For 5 % Topical SolutionProspective 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. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfamylon® For 5 % Topical SolutionAlso: mafenide acetateSulfamylon® 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. | Drug | Prospective Patients/Active Drug |
| Topical Antimicrobial/Antifungal MedicationsAlso: Bacitracin; Amphotericin B; others noted below.'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin; Nystatin; Fluconazole; Piperacillin Sodium with Tazobactam. | Drug | Historical Control |
Primary outcome
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.
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.
6 secondary outcomes
Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population
Time frame: 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
Time frame: Days 18 to 21
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
Time frame: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Time frame: Days 5-7
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Time frame: Days 12-14
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Time frame: Days 18-21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Davis, MD study director
Mylan Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfamylon® For 5 % Topical Solution and Topical Antimicrobial/Antifungal Medications in people with Burns, run by Mylan Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.