Cytal® Wound Matrix and MicroMatrix® Wound Study

Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds

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.

Study Overview

• Status: Terminated
• Conditions: Wounds
• Intervention / Treatment: Device: ACell Arm

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • New York
    • Long Island City, New York, United States, 11501
      • NYU Winthrop Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Cytal® Wound Matrix and/or MicroMatrix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Wound Closure	Determine time to complete wound closure using Silhouette Star camera system.	up to 52 week visit (until study completion)
Wound Characteristics	Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.	up to 52 week visit (until study completion)
Incidence of Bridging	Bridging to definitive closure or transition to cellular therapy	up to 52 week visit (until study completion)
Visual Analogue Scale (VAS) for Pain	VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity.	Up to 52 week visit (until study completion)
Wound Quality of Life (W-QOL)	W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life.	Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)	The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment	Up to 52 week visit (until study completion)
Complete Wound Management	Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.	up to 52 week visit (until study completion)
Wound-Related Adverse Events	Number and type of wound-related adverse events as recorded on adverse event case report forms.	up to 52 week visit (until study completion)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct Product and Care Costs	Measures the direct cost of products	up to 52 week visit (until study completion)
Indirect Product and Care Costs	Measures the total of the indirect and incidental costs	up to 52 week visit (until study completion)
Return to Work Status	Measures change in "return to work status" and/or "reported work status"	up to 52 week visit (until study completion)
Cost Associated With AEs, UADEs and SAEs	Measure frequency of wound specific events, capturing incident specific costs per event.	up to 52 week visit (until study completion)
Wound Pathology	Measures the effect of treatment through quantitative analysis	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Winthrop University Hospital
• Investigators: Study Chair: Allison Matthews, Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): January 27, 2020
• Study Completion (Actual): January 27, 2020

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: ACell; Wounds; Extracellular Matrix; ACell MicroMatrix®; Urinary Bladder Matrix; ACell Cytal® Wound Matrix
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CR2017-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes