Cytal® Wound Matrix and MicroMatrix® Wound Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: ACell Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACell Arm<br>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<br>* Cytal® Wound Matrix and/or MicroMatrix®<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wounds, ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Extracellular Matrix, Urinary Bladder Matrix