Trial Outcomes & Findings for Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NCT NCT02246608)
NCT ID: NCT02246608
Last Updated: 2018-09-27
Results Overview
Wound dimensions will be measured weekly and monitored for changes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-09-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Baseline characteristics by cohort
| Measure |
NPWT Standard of Care
n=10 Participants
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.
|
NPWT Standard of Care Plus Oasis Wound Product
n=11 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksWound dimensions will be measured weekly and monitored for changes
Outcome measures
| Measure |
NPWT Standard of Care
n=10 Participants
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.
|
NPWT Standard of Care Plus Oasis Wound Product
n=11 Participants
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.
|
|---|---|---|
|
Closure Rate of Non-healing Wounds
|
45.79 percentage of healing
Standard Deviation 38.72
|
89.98 percentage of healing
Standard Deviation 9.47
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Outcome measures
Outcome data not reported
Adverse Events
NPWT Standard of Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
NPWT Standard of Care Plus Oasis Wound Product
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPWT Standard of Care
n=10 participants at risk
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.
|
NPWT Standard of Care Plus Oasis Wound Product
n=11 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Gangrene
|
0.00%
0/10 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
|
Renal and urinary disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
0.00%
0/11 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
|
Vascular disorders
Septic shock
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
0.00%
0/11 • Adverse events were collected from time of consent to completion of 12 week study visit.
The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
|
Other adverse events
Adverse event data not reported
Additional Information
Manager, Research Operation and Regulatory Compliance
Kettering Health Network
Phone: 937-395-8367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place