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This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:
Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.
The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine NPWT Standard of Care | Active Comparator | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed. |
|
| NPWT Standard of Care plus Oasis wound product | Experimental | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT Standard of Care plus Oasis wound product | Device | Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns. |
| Measure | Description | Time Frame |
|---|---|---|
| Closure Rate of Non-healing Wounds | Wound dimensions will be measured weekly and monitored for changes | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Factors | Fluid collected from the wound will be examined for the presence of growth factors and interleukins. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Simman, MD | Kettering Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPWT Standard of Care | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 30, 2015 |
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| Routine NPWT Standard of Care | Device | Specialized material, often foam, designed to protect the wound and promote healing during NPWT. |
|
| NPWT Standard of Care Plus Oasis Wound Product |
Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NPWT Standard of Care | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT. |
| BG001 | NPWT Standard of Care Plus Oasis Wound Product | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Closure Rate of Non-healing Wounds | Wound dimensions will be measured weekly and monitored for changes | Posted | Mean | Standard Deviation | percentage of healing | 12 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Growth Factors | Fluid collected from the wound will be examined for the presence of growth factors and interleukins. | Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements. | Posted | 12 weeks |
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Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected.
Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
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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 | NPWT Standard of Care | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT. | 0 | 10 | 2 | 10 | 0 | 10 |
| EG001 | NPWT Standard of Care Plus Oasis Wound Product | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT plus Oasis wound product: Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns. | 0 | 11 | 1 | 11 | 0 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gangrene | Vascular disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Septic shock | Vascular disorders | Non-systematic Assessment | infection from PEG tube malfunction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Research Operation and Regulatory Compliance | Kettering Health Network | 937-395-8367 | innovationcenter@ketteringhealth.org |
| Feb 5, 2018 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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