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).
Device: Biodegradable Temporizing Matrix
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02905435
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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).
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.
All locations for NCT02905435
United States (5)
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States, 85008
University of California Davis Medical Center
Sacramento, California, United States, 95817
Tampa General Hospital
Tampa, Florida, United States, 33606
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
View full eligibility
Tris trial is registered with FDA with number: NCT02905435. The sponsor of the trial is PolyNovo Biomaterials Pty Ltd. and it is looking for 15 volunteers for the current phase.
Official trial title: A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.
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