Cytal® Wound Matrix and MicroMatrix® Wound Study

Terminated

Conditions: Wounds

Interventions: Device: ACell Arm

Registration Number: NCT03632954

Lead Sponsor: Integra LifeSciences Corporation

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 37

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACell Arm	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Completely Healed Wounds	Up to 12 weeks	Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Wound Size Change	Up to 12 weeks	Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.

Secondary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure	up to 52 week visit (until study completion)	Determine time to complete wound closure using Silhouette Star camera system.
Visual Analogue Scale (VAS) for Pain	Up to 52 week visit (until study completion)	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.
Complete Wound Management	up to 52 week visit (until study completion)	Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.
Wound-Related Adverse Events	up to 52 week visit (until study completion)	Number and type of wound-related adverse events as recorded on adverse event case report forms.
Wound Characteristics	up to 52 week visit (until study completion)	Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.
Incidence of Bridging	up to 52 week visit (until study completion)	Bridging to definitive closure or transition to cellular therapy
Wound Quality of Life (W-QOL)	Up to 52 week visit (until study completion)	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.
Katz Index of Independence in Activities of Daily Living (KATZ ADL)	Up to 52 week visit (until study completion)	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