- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765737
Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85008
- Arizona Burn Center
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California
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Los Angeles, California, United States, 90032
- Keck School of Medicine
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San Diego, California, United States, 92103
- University of San Diego Nedical Center
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Nebraska
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Lincoln, Nebraska, United States, 68506
- St Elizabeth Reg Med Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Bruce Cairns Surgery Burn Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Drexel University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
ll patients enrolled must meet all the following criteria:
Patient with burn injury that meets all of the following requirements:
- Occurred within the last 48 hours
- Wound is thermal in nature
- Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
- Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
- Burn area(s) located on smooth, flat surface
- 2 burn areas, each with a minimum size of 16cm2 (burn areas may be two separate burns or within one large burn, see Section 9.4.2)
- Age ≥ 12 months and ≤ 70 years
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
Burns meeting any of the following criteria:
- Mechanism of injury was electrical, radiation, chemical or frostbite
- Wound is larger than 200 cm2
- Clinically infected burn (as judged by the investigator)
Previous or planned treatment of the Burn Area(s) with any of the following:
- Biological Skin Substitutes (including Apligraf®, Dermagraft®, etc.)
Patient criteria that will make patient ineligible for enrollment:
- Ventilator dependence
- Active malignant disease or patient is less than 1 year disease-free
- Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
- Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Presence of any condition that is likely to compromise healing in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Patient has been on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
Allergy or known sensitivity to any of the following:
- Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
Silver
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Treatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B
|
Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
Other Names:
|
Active Comparator: Group 2
Treatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A
|
Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing Rate
Time Frame: 3 weeks
|
95% epitheliazation as assesses by the investigator
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3 weeks
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Freedom from Scarring
Time Frame: 3 Months
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Vancouver Scar Scale: consists of four variables: pliability, vascularity, height (thickness), and pigmentation.
Each variable has four to six possible scores.
A total score ranges from 0 to 14, whereby a score of 0 reflects normal skin.
|
3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in pain
Time Frame: 3 weeks
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Visual Analog Scale or FLACC Behavioral Pain Assessment Scale:VAS-No pain on left of line, worst pain imaginable on the right of line; FLACC- 0-2, (0 being least uncomfortable to 2 which is very uncomfortable)
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3 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFBUR002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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