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TerminatedNCT00634166Updated Sep 29, 2022Results posted

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

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. · Phase 4, Interventional, and Treatment

Why this study was terminated
FDA request as study could not serve as the confirmatory trial.
Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Non-randomized
Ages
3 Months and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Burns

Keywords

  • thermal injuries
  • burns
  • Burn Patients
03

Who can participate

Ages eligible
3 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Other
    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

    Drug: Topical Antimicrobial/Antifungal Medications

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

    Drug: Sulfamylon® For 5 % Topical Solution

Interventions

  • DrugSulfamylon® 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

  • DrugTopical 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.

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

05

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

06

Results

Posted Sep 29, 2014
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%.

Participant flow

Participant flow — Overall Study
MilestoneHistorical ControlProspective Patients/Active Drug
Started82138
Completed2278
Not completed6060

Outcome measures

PrimaryPercentage 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.
Reported as:
Number · Percentage of Participants
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.
Percentage of ParticipantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.4.94.3
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With All-cause Graft Loss at Days 12 to 14 in the FAS Population20.32.7
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With All-cause Graft Loss at Days 18 to 21 in the FAS Population4.56
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With Treatment Failure at Days 5 to 7 in the FAS Population13.41.4
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With Infectious Graft Loss at Days 5 to 7 in the FAS Population2.40.7
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With Infectious Graft Loss at Days 12 to 14 in the FAS Population3.40.0
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population
Percentage of participantsHistorical ControlProspective Patients/Active Drug
Percentage of Participants With Infectious Graft Loss at Days 18 to 21 in the FAS Population0.01.3

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Historical Control—9/82 (11%)74/82 (90.2%)
Prospective Patients/Active Drug—27/138 (19.6%)130/138 (94.2%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventHistorical ControlProspective Patients/Active Drug
SepsisInfections and infestations2/829/138
Deep Vein ThrombosisVascular disorders0/829/138
Respiratory FailureRespiratory, thoracic and mediastinal disorders0/827/138
Renal FailureRenal and urinary disorders1/826/138
PneumoniaInfections and infestations1/825/138
Multi-organ FailureGeneral disorders0/824/138
Renal Failure - acuteRenal and urinary disorders2/824/138
HypotensionVascular disorders1/824/138
HypoxiaRespiratory, thoracic and mediastinal disorders0/823/138
Atrial FibrillationCardiac disorders1/822/138
Most frequent other events
Showing 10 of 40
Most frequent other events
EventHistorical ControlProspective Patients/Active Drug
ConstipationGastrointestinal disorders34/8242/138
AnaemiaBlood and lymphatic system disorders16/8227/138
PneumoniaInfections and infestations16/8219/138
PruritusSkin and subcutaneous tissue disorders12/8225/138
InsomniaPsychiatric disorders12/8223/138
NauseaGastrointestinal disorders13/8218/138
PyrexiaGeneral disorders12/8220/138
TachycardiaCardiac disorders4/8220/138
AgitationPsychiatric disorders8/8219/138
HyperglycemiaMetabolism and nutrition disorders4/8217/138

Baseline characteristics

Age, Continuous
Age, Continuous(years)Historical ControlProspective Patients/Active DrugTotal
Mean38.9 ± 18.9144.7 ± 17.8742.6 ± 18.44
Age, Customized
Age, Customized(participants)Historical ControlProspective Patients/Active DrugTotal
<18 years11516
>= 18 years71133204
Sex/Gender, Customized
Sex/Gender, Customized(participants)Historical ControlProspective Patients/Active DrugTotal
Female192948
Male63109172
Region of Enrollment
Region of Enrollment(participants)Historical ControlProspective Patients/Active DrugTotal
United States82138220
07

Study locations

9 sites
  • University of South Alabama Medical Center
    Mobile, Alabama 36617, United States
  • Arrowhead Regional Medical Center
    Redlands, California 92373, United States
  • Shands Burn Center - Univ. of Florida
    Gainesville, Florida 32610, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • The Plastic Surgery Institute - Southern Illinois Univ. School of Medicine
    Springfield, Illinois 62794-9653, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • John's Hopkins Burn Center
    Baltimore, Maryland 21224, United States
  • University of Missouri Healthcare - Dept. of Surgery
    Columbia, Missouri 65212, United States
  • Wake Forest University - Department of General Surgery
    Winston-Salem, North Carolina 27157, United States
08

Registry details

Key details

Study ID
NCT00634166
Lead sponsor
Mylan Inc.
Collaborators
Mylan Bertek Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 12, 2008
Start date
Sep 2007
Primary completion
Dec 2013
Completion
Apr 2014
Results posted
Sep 29, 2014
Last update
Sep 29, 2022

Study contacts

Eric Davis, MD
study director · Mylan Inc.

Oversight

Data monitoring committee
No
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