67
Participants
Start Date
May 1, 2024
Primary Completion Date
June 5, 2025
Study Completion Date
August 5, 2025
innovaMatrix AC
"nnovaMatrix® AC consists of ECM derived from porcine placental material. The device is supplied in a variety of sterile sheet configurations. It is packaged in double peel-open packages and is intended for single use only. The device is terminally sterilised using E-Beam sterilisation and is for licensed healthcare practitioner use only.~InnovaMatrix® AC is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulphated glycosaminoglycans. The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.~InnovaMatrix® AC received Food and Drug Administration (FDA) clearance under K193552 on October 21, 2020. InnovaMatrix® AC has an FDA classification of KGN, which designates it as a collagen wound dressing."
Charleston Wound Care Centre, Mt. Pleasant
Lead Sponsor
Charleston Wound Care Centre
UNKNOWN
ConvaTec Inc.
INDUSTRY