Back to resultsEffect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Primary Purpose
Open Wound Abdominal Wall, Wound Non Healing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NPWT Standard of Care plus Oasis wound product
Routine NPWT Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Open Wound Abdominal Wall
Eligibility Criteria
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.
Sites / Locations
- Kettering Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine NPWT Standard of Care
NPWT Standard of Care plus Oasis wound product
Arm Description
Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.
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.
Outcomes
Primary Outcome Measures
Closure Rate of Non-healing Wounds
Wound dimensions will be measured weekly and monitored for changes
Secondary Outcome Measures
Growth Factors
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Full Information
NCT ID
NCT02246608
First Posted
September 18, 2014
Last Updated
August 28, 2018
Sponsor
Kettering Health Network
1. Study Identification
Unique Protocol Identification Number
NCT02246608
Brief Title
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Official Title
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kettering Health Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Wound Abdominal Wall, Wound Non Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine NPWT Standard of Care
Arm Type
Active Comparator
Arm Description
Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.
Arm Title
NPWT Standard of Care plus Oasis wound product
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NPWT Standard of Care plus Oasis wound product
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Routine NPWT Standard of Care
Intervention Description
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Primary Outcome Measure Information:
Title
Closure Rate of Non-healing Wounds
Description
Wound dimensions will be measured weekly and monitored for changes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Growth Factors
Description
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Simman, MD
Organizational Affiliation
Kettering Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
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