A Phase 4 interventional study of Sulfamylon® For 5 % Topical Solution and Topical Antimicrobial/Antifungal Medications in Burns, sponsored by Mylan Inc.. Terminated at 9 sites in United States. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Mylan Inc. (part of Viatris Inc.) · Phase 4, Interventional, and Treatment
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.
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).
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's enrollment of 220 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
First submitted before Mylan Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order for prospective subjects to be eligible for entry into the study:
Exclusion Criteria:
Prospective subjects will be excluded from the study for the following reasons:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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
'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.
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.
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.
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
All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 18-21
| Milestone | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Started | 82 | 138 |
| Completed | 22 | 78 |
| Not completed | 60 | 60 |
| Percentage of Participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7. | 4.9 | 4.3 |
All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population | 20.3 | 2.7 |
All cause graft loss is defined as graft adhesion of \< 85% for the initial meshed autograft procedure.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population | 4.5 | 6 |
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.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population | 13.4 | 1.4 |
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population | 2.4 | 0.7 |
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population | 3.4 | 0.0 |
Graft adhesion of \< 85% for the initial meshed autograft procedure due to infection.
| Percentage of participants | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population | 0.0 | 1.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Historical Control | — | 9/82 (11%) | 74/82 (90.2%) |
| Prospective Patients/Active Drug | — | 27/138 (19.6%) | 130/138 (94.2%) |
| Event | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| SepsisInfections and infestations | 2/82 | 9/138 |
| Deep Vein ThrombosisVascular disorders | 0/82 | 9/138 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/82 | 7/138 |
| Renal FailureRenal and urinary disorders | 1/82 | 6/138 |
| PneumoniaInfections and infestations | 1/82 | 5/138 |
| Multi-organ FailureGeneral disorders | 0/82 | 4/138 |
| Renal Failure - acuteRenal and urinary disorders | 2/82 | 4/138 |
| HypotensionVascular disorders | 1/82 | 4/138 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/82 | 3/138 |
| Atrial FibrillationCardiac disorders | 1/82 | 2/138 |
| Event | Historical Control | Prospective Patients/Active Drug |
|---|---|---|
| ConstipationGastrointestinal disorders | 34/82 | 42/138 |
| AnaemiaBlood and lymphatic system disorders | 16/82 | 27/138 |
| PneumoniaInfections and infestations | 16/82 | 19/138 |
| PruritusSkin and subcutaneous tissue disorders | 12/82 | 25/138 |
| InsomniaPsychiatric disorders | 12/82 | 23/138 |
| NauseaGastrointestinal disorders | 13/82 | 18/138 |
| PyrexiaGeneral disorders | 12/82 | 20/138 |
| TachycardiaCardiac disorders | 4/82 | 20/138 |
| AgitationPsychiatric disorders | 8/82 | 19/138 |
| HyperglycemiaMetabolism and nutrition disorders | 4/82 | 17/138 |
| Age, Continuous(years) | Historical Control | Prospective Patients/Active Drug | Total |
|---|---|---|---|
| Mean | 38.9 ± 18.91 | 44.7 ± 17.87 | 42.6 ± 18.44 |
| Age, Customized(participants) | Historical Control | Prospective Patients/Active Drug | Total |
|---|---|---|---|
| <18 years | 11 | 5 | 16 |
| >= 18 years | 71 | 133 | 204 |
| Sex/Gender, Customized(participants) | Historical Control | Prospective Patients/Active Drug | Total |
|---|---|---|---|
| Female | 19 | 29 | 48 |
| Male | 63 | 109 | 172 |
| Region of Enrollment(participants) | Historical Control | Prospective Patients/Active Drug | Total |
|---|---|---|---|
| United States | 82 | 138 | 220 |
The record gives a start of Sep 2007, a primary completion of Dec 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2014, 9 months after primary completion.
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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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