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: 1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
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.
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Kettering Medical Center
Kettering, Ohio, United States
Closure Rate of Non-healing Wounds
Wound dimensions will be measured weekly and monitored for changes
Time frame: 12 weeks
Growth Factors
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Time frame: 12 weeks
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