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Sponsor Decision
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| Name | Class |
|---|---|
| Winthrop University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACell Arm | Device | Cytal® Wound Matrix and/or MicroMatrix® |
|
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected from NYU Winthrop Hospital, including the outpatient Wound Healing Center clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Matthews | Integra LifeSciences Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Winthrop Hospital | Long Island City | New York | 11501 | United States |
There is no plan to share IPD to other researchers at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Completely Healed Wounds | Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage. | The study was terminated by Sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix® |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inpatient wound management | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
Due to early termination, additional primary, secondary, and tertiary endpoint analyses were not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Matthews | Integra LifeSciences | (443) 766-3869 | allison.matthews@integralife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2019 | Jan 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Formalin fixed paraffin-embedded wound biopsy tissue.
| 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) |
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Data was not collected and outcome measure analysis was not performed. | Posted | Up to 12 weeks |
|
|
| Secondary | Time to Complete Wound Closure | Determine time to complete wound closure using Silhouette Star camera system. | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Secondary | Wound Characteristics | Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate. | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Secondary | Incidence of Bridging | Bridging to definitive closure or transition to cellular therapy | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Secondary | 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. | Data was not collected and outcome measure analysis was not performed. | Posted | Up to 52 week visit (until study completion) |
|
|
| Secondary | 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. | Data was not collected and outcome measure analysis was not performed. | Posted | Up to 52 week visit (until study completion) |
|
|
| Secondary | 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 | Data was not collected and outcome measure analysis was not performed. | Posted | Up to 52 week visit (until study completion) |
|
|
| Secondary | Complete Wound Management | Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing. | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Secondary | Wound-Related Adverse Events | Number and type of wound-related adverse events as recorded on adverse event case report forms. | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Other Pre-specified | Direct Product and Care Costs | Measures the direct cost of products | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Other Pre-specified | Indirect Product and Care Costs | Measures the total of the indirect and incidental costs | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Other Pre-specified | Return to Work Status | Measures change in "return to work status" and/or "reported work status" | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Other Pre-specified | Cost Associated With AEs, UADEs and SAEs | Measure frequency of wound specific events, capturing incident specific costs per event. | Data was not collected and outcome measure analysis was not performed. | Posted | up to 52 week visit (until study completion) |
|
|
| Other Pre-specified | Wound Pathology | Measures the effect of treatment through quantitative analysis | Data was not collected and outcome measure analysis was not performed. | Posted | Up to 12 weeks |
|
|
| 1 |
| 37 |
| 6 |
| 37 |
| 17 |
| 37 |
| abdominal pain/septic shock | Infections and infestations | Non-systematic Assessment |
|
| bacteremia | Infections and infestations | Non-systematic Assessment |
|
| discharge at device application site | Infections and infestations | Non-systematic Assessment |
|
| urinary tract infection/sepsis | Infections and infestations | Non-systematic Assessment |
|
| accidental fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| shortness of breath/cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| scheduled surgery and hospitalization | Surgical and medical procedures | Non-systematic Assessment |
|
| bleeding at wound site | General disorders | Non-systematic Assessment |
|
| hematoma at device application site | General disorders | Non-systematic Assessment |
|
| increase in wound size | General disorders | Non-systematic Assessment |
|
| inflammation at device application site | General disorders | Non-systematic Assessment |
|
| malaise | General disorders | Non-systematic Assessment |
|
| near syncope episode | General disorders | Non-systematic Assessment |
|
| pain at application site, discharge at application site | General disorders | Non-systematic Assessment |
|
| pain at device application site (excessive or exacerbated) | General disorders | Non-systematic Assessment |
|
| cellulitis at device application site | Infections and infestations | Non-systematic Assessment |
|
| cellulitis, leg | Infections and infestations | Non-systematic Assessment |
|
| conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| osteomyelitis at device application site | Infections and infestations | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| wrist injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| burning sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| facial rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| seroma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| skin maceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| small maculopapular rash (possible reaction to complex wound dressing) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| wound necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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