Cytal® Wound Matrix and MicroMatrix® Wound Study

Integra LifeSciences

Status: Terminated

Conditions: Wounds

Treatments: Device: ACell Arm

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03632954

CR2017-012

Details and patient eligibility

About

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.

Full description

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Enrollment: 37 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
2. Subject is at least 21 years of age.
3. 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.
4. Subject or legal representative is willing to provide informed consent.
5. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Exclusion criteria

1. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
2. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
3. 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.
4. 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).
5. Wound with exposed organs or hardware.
6. Wound with burn etiology.

Trial design

37 participants in 1 patient group

ACell Arm

Description:

Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.

Treatment:

Device: ACell Arm