Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
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|ClinicalTrials.gov Identifier: NCT02246608|
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : August 21, 2018
Last Update Posted : September 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Open Wound Abdominal Wall Wound Non Healing||Device: NPWT Standard of Care plus Oasis wound product Device: Routine NPWT Standard of Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||January 2018|
Active Comparator: Routine NPWT Standard of Care
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
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Experimental: 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 in addition to standard of care dressing.
Device: NPWT Standard of Care 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.
- Closure Rate of Non-healing Wounds [ Time Frame: 12 weeks ]Wound dimensions will be measured weekly and monitored for changes
- Growth Factors [ Time Frame: 12 weeks ]Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246608
|United States, Ohio|
|Kettering Medical Center|
|Kettering, Ohio, United States, 45429|
|Principal Investigator:||Richard Simman, MD||Kettering Health Network|