Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries

Completed · Not applicable

Conditions studied: Burns

In brief

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).

Key facts

Study ID

NCT02905435

Run by

PolyNovo Biomaterials Pty Ltd.

People needed

15

Starts

2016-11-05

Expected to finish

2019-09-18

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Arizona Burn Center at Maricopa Medical Center — Phoenix, Arizona, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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