Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either: Oasis® matrix, applied to the wound, along with standard of care including NPWT OR Standard foam, applied to the wound prior to activation of NPWT, which is standard care. 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.

Official Title
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Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)

Conditions
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Open Wound Abdominal Wall, Wound Non Healing

Intervention / Treatment
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* Device: NPWT Standard of Care plus Oasis wound product
* Device: Routine NPWT Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection. HbA1C < 8 (if patient is diabetic) Adequate nutrition including albumin above 2.0 and prealbumin above 15. Exclusion Criteria: Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues. Patients with Infected wounds.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine NPWT Standard of Care<br>Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed. | Device: Routine NPWT Standard of Care<br>* Specialized material, often foam, designed to protect the wound and promote healing during NPWT.<br>|
| Experimental: NPWT Standard of Care plus Oasis wound product<br>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. | Device: NPWT Standard of Care plus Oasis wound product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure Rate of Non-healing Wounds | Wound dimensions will be measured weekly and monitored for changes | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Factors | Fluid collected from the wound will be examined for the presence of growth factors and interleukins. | 12 weeks |