N/A
N=43
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Open Wound Abdominal Wall · Wound Non Healing
Bottom Line
View on ClinicalTrials.gov: NCT02246608 ↗Enrolled (actual)
43
Serious AEs
14.3%
Results posted
Aug 2018
Primary outcome: Primary: Closure Rate of Non-healing Wounds — 45.79; 89.98 percentage of healing
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NPWT Standard of Care plus Oasis wound product (Device); Routine NPWT Standard of Care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kettering Health Network
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Closure Rate of Non-healing Wounds |
45.79; 89.98 | — |
| SECONDARY Growth Factors |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02246608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.