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Sponsor Decision
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A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.
This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix | Device | Porcine-derived extracellular matrix will be used in powder and 2-Layer wound sheet form in masses up to 1000 mg. Each product is intended for a one-time use only. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Wound Closure | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | Up to 3 month visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | Up to 3 month visit |
| Katz Index of Independence in Activities of Daily Living (KATZ ADL) |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected from the medical offices of the Principal Investigator, Dr. Massarotti, and CO-Investigator, Dr. Chudzinski.
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| Name | Affiliation | Role |
|---|---|---|
| Haane Massarotti, MD | Florida Hospital Tampa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The study was terminated by Sponsor; no data outcome analyses were conducted.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Rate of Wound Closure | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | Data was collected from the two participants in the study however, rate of wound closure was not analyzed due to an extremely small sample size and study termination by Sponsor. | Posted | Up to 3 month visit |
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5 months
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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 | All Participants | All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to standard of care Negative Pressure Wound Therapy on their pilonidal wounds. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Infection | Infections and infestations | Systematic Assessment | The Subject presented with surgical site infection at their 6 weeks visit. |
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| 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 | Jul 2, 2018 | Jun 24, 2020 | Prot_SAP_000.pdf |
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The study was terminated by Sponsor; no outcome measure data analyses were conducted.
| Up to 3 month visit |
| Wound Related Adverse Events | Number and type of wound related adverse events as recorded on adverse event case report forms | Up to 3 month visit |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Other Pre-specified | Visual Analogue Scale (VAS) for Pain | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses. | Posted | Up to 3 month visit |
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| Other Pre-specified | Katz Index of Independence in Activities of Daily Living (KATZ ADL) | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses. | Posted | Up to 3 month visit |
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| Other Pre-specified | Wound Related Adverse Events | Number and type of wound related adverse events as recorded on adverse event case report forms | The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses. | Posted | Up to 3 month visit |
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