Kettering Medical Center
Kettering, Ohio, 45429, United States
Completed
NCT Number: NCT02246608
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–89 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
NPWT Standard of Care plus Oasis wound product
DeviceOasis® 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.
Routine NPWT Standard of Care
DeviceSpecialized material, often foam, designed to protect the wound and promote healing during NPWT.
Primary outcomes
-
Closure Rate of Non-healing Wounds
Time frame: 12 weeks
Wound dimensions will be measured weekly and monitored for changes
Secondary outcomes
-
Growth Factors
Time frame: 12 weeks
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Sponsors and collaborators
Lead sponsor
Kettering Health Network
Other
Registry information
Official study title
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Sep 23, 2014
- Registry last updated
- Sep 27, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.