Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Status: | Active, not recruiting |
---|---|
Conditions: | Other Indications, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/22/2019 |
Start Date: | November 2016 |
End Date: | December 2019 |
A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.
This is a multi-center, single arm, traditional feasibility study to allow a preliminary
assessment of the safety and effectiveness of a new method of treating skin burns using
Biodegradable Temporizing Matrix (BTM).
assessment of the safety and effectiveness of a new method of treating skin burns using
Biodegradable Temporizing Matrix (BTM).
This is a multi-center, single arm, traditional feasibility study to allow a preliminary
assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns
will have BTM devices implanted in areas with deep partial or full thickness burns to treat
at least 5% TBSA.
assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns
will have BTM devices implanted in areas with deep partial or full thickness burns to treat
at least 5% TBSA.
Inclusion Criteria:
- Provides written informed consent (directly or via legal representative) prior to any
clinical trial procedures being performed.
- Willing to comply with all study procedures and expects to be available for the
duration of the study.
- Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age.
- Patients with deep partial or full thickness burns (between 10% and 70% inclusive of
their TBSA).
Exclusion Criteria:
- Has a known hypersensitivity to polyurethane or silver-containing materials.
- Multiple traumas (significant traumatic injury to a solid organ in addition to skin).
- Presence of a medical condition with a life expectancy of less than 12 months, such as
advanced malignancy.
- Presence of a medical condition that might interfere with treatment evaluation; or
require a change in therapy including but not limited to, significant immune
deficiency, or skin or vascular diseases in the area of the wound.
- Female with known or suspected pregnancy, planned pregnancy, or lactation.
- Has had exposure to any other investigational agent within the last 6 months.
- Has a clinically significant psychiatric illness.
- Has a condition the Investigator believes would interfere with the ability to comply
with study instructions, or that might confound the interpretation of the study
results or put the subject at undue risk.
We found this trial at
5
sites
Memphis, Tennessee 38163
Principal Investigator: William L Hickerson, MD
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1 Tampa General Cir
Tampa, Florida 33606
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: David J Smith, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Phoenix, Arizona 85008
Principal Investigator: Kevin N Foster, MD
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Tina L Palmieri, MD
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Joseph A Molnar, MD, PhD
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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