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

PolyNovo North America

Status

Completed

Conditions

Burns

Treatments

Device: Biodegradable Temporizing Matrix

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT02905435

CP-002

Details and patient eligibility

About

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).

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.