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

NCT07170566 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2025-09-15

No results posted yet for this study

Summary

The use of a decellularised porcine placental extracellular matrix in hard-to-heal wounds: A retrospective study of the real-world performance of InnovaMatrix® AC at a single centre.

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.

Sponsors & Collaborators

  • Charleston Wound Care Centre

    collaborator UNKNOWN

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Dr Michaelis, DO · Charleston Wound Care Centre

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-06-05
Completion
2025-08-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170566 on ClinicalTrials.gov