Cytal® Wound Matrix and MicroMatrix® Wound Study

NCT03632954 | Terminated Results DMC FDA Device

• 1 other identifier: CR2017-012
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

Wounds; ACell; ACell MicroMatrix®; ACell Cytal® Wound Matrix; Extracellular Matrix; Urinary Bladder Matrix

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Completely Healed Wounds

  Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.

  Up to 12 weeks

• Wound Size Change

  Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.

  Up to 12 weeks

Secondary Outcomes (8)

• Time to Complete Wound Closure

  up to 52 week visit (until study completion)

• Wound Characteristics

  up to 52 week visit (until study completion)

• Incidence of Bridging

  up to 52 week visit (until study completion)

• Visual Analogue Scale (VAS) for Pain

  Up to 52 week visit (until study completion)

• Wound Quality of Life (W-QOL)

  Up to 52 week visit (until study completion)

Other Outcomes (5)

• Direct Product and Care Costs

  up to 52 week visit (until study completion)

• Indirect Product and Care Costs

  up to 52 week visit (until study completion)

• Return to Work Status

  up to 52 week visit (until study completion)

Study Arms (1)

ACell Arm

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.

Device: ACell Arm

Interventions

ACell Arm DEVICE

Cytal® Wound Matrix and/or MicroMatrix®

ACell Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from NYU Winthrop Hospital, including the outpatient Wound Healing Center clinic.

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'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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Winthrop University Hospital: collaborator

Study Sites (1)

NYU Winthrop Hospital

Long Island City, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin fixed paraffin-embedded wound biopsy tissue.

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

Due to early termination, additional primary, secondary, and tertiary endpoint analyses were not performed.

Results Point of Contact

• Title: Allison Matthews
• Organization: Integra LifeSciences

allison.matthews@integralife.com

(443) 766-3869

Study Officials

• Allison Matthews

  Integra LifeSciences Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 16, 2018
• Study Start: December 11, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)