Clinical trial NCT03632954: Cytal® Wound Matrix and MicroMatrix® Wound Study
Official title: Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds
Keywords: Wounds
ACell
ACell MicroMatrix®
ACell Cytal® Wound Matrix
Extracellular Matrix
Urinary Bladder Matrix
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Winthrop University Hospital
First posted: 2018-08-16
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from NYU Winthrop Hospital, including the outpatient Wound Healing Center clinic.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Completely Healed Wounds
timeFrame: Up to 12 weeks
measure: Wound Size Change
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Time to Complete Wound Closure
timeFrame: up to 52 week visit (until study completion)
measure: Wound Characteristics
timeFrame: up to 52 week visit (until study completion)
measure: Incidence of Bridging
timeFrame: up to 52 week visit (until study completion)
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: Up to 52 week visit (until study completion)
measure: Wound Quality of Life (W-QOL)
timeFrame: Up to 52 week visit (until study completion)
measure: Katz Index of Independence in Activities of Daily Living (KATZ ADL)
timeFrame: Up to 52 week visit (until study completion)
measure: Complete Wound Management
timeFrame: up to 52 week visit (until study completion)
measure: Wound-Related Adverse Events
timeFrame: up to 52 week visit (until study completion)
Other outcomes:
measure: Direct Product and Care Costs
timeFrame: up to 52 week visit (until study completion)
measure: Indirect Product and Care Costs
timeFrame: up to 52 week visit (until study completion)
measure: Return to Work Status
timeFrame: up to 52 week visit (until study completion)
measure: Cost Associated With AEs, UADEs and SAEs
timeFrame: up to 52 week visit (until study completion)
measure: Wound Pathology
timeFrame: Up to 12 weeks
Locations:
city: Long Island City
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: Integra LifeSciences Corporation
name: Allison Matthews
role: STUDY_CHAIR
References: