Cytal® Wound Matrix and MicroMatrix® Wound Study

Stopped early

Conditions studied: Wounds

In brief

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Key facts

Study ID

NCT03632954

Run by

Integra LifeSciences Corporation

People needed

37

Starts

2018-12-11

Expected to finish

2020-01-27

Last updated by the study team

2021-05-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
• Subject is at least 21 years of age.
• Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
• Subject or legal representative is willing to provide informed consent.
• For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

You may not qualify if…

• Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
• Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
• The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).
• Wound with exposed organs or hardware.
• Wound with burn etiology.

Where it is running

• NYU Winthrop Hospital — Long Island City, New York, United States

Full record on ClinicalTrials.gov

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