Open Wound Abdominal Wall, Wound Non Healing
Conditions
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: 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.
Interventions
DEVICENPWT 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.
DEVICERoutine NPWT Standard of Care
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Sponsors
Kettering Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure Rate of Non-healing Wounds | 12 weeks | Wound dimensions will be measured weekly and monitored for changes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth Factors | 12 weeks | Fluid collected from the wound will be examined for the presence of growth factors and interleukins. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NPWT Standard of Care Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied.
Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT. | 10 |
| 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.
Routine NPWT 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. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | NPWT Standard of Care | NPWT Standard of Care Plus Oasis Wound Product | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 2 / 10 | 1 / 11 |
Outcome results
Primary
Closure Rate of Non-healing Wounds
Wound dimensions will be measured weekly and monitored for changes
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPWT Standard of Care | Closure Rate of Non-healing Wounds | 45.79 percentage of healing | Standard Deviation 38.72 |
| NPWT Standard of Care Plus Oasis Wound Product | Closure Rate of Non-healing Wounds | 89.98 percentage of healing | Standard Deviation 9.47 |
Secondary
Growth Factors
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Time frame: 12 weeks
Population: Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.