A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre

CompletedOBSERVATIONAL
Enrollment

67

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

June 5, 2025

Study Completion Date

August 5, 2025

Conditions
Wound Heal
Interventions
DEVICE

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."

Trial Locations (1)

29464

Charleston Wound Care Centre, Mt. Pleasant

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Charleston Wound Care Centre

UNKNOWN

lead

ConvaTec Inc.

INDUSTRY

NCT07170566 - A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre | Biotech Hunter | Biotech Hunter