Phase 1
N=14
The Effect of OASIS Ultra on Critical Sized Wound Healing
Traumatic Wound · Infective Wound · Iatrogenic Critical Sized Wound Defects · Wound Healing
Bottom Line
View on ClinicalTrials.gov: NCT01848821 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later — -20.7; -13.9 cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OASIS Ultra (Device); Wound VAC Standard Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later |
-20.7; -13.9 | — |
| SECONDARY Change in Histological Acute Inflammation Score From Baseline to Skin Grafting Procedure |
-2.5; 0 | — |
| SECONDARY Change in Histological Repair Score From Baseline to Skin Grafting Procedure |
4.5; 2.5 | — |
Summary
The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovascularization present compared with control wounds. The investigators hypothesize that OASIS® Ultra will provide a faster healing time as well as the re-establishment of a dermis for further skin graft application. The investigators anticipate that our study will define parameters for the application of OASIS® Ultra as well as potentially demonstrating the advantages in healing time, healed wound quality and hospital stay.
Eligibility Criteria
Inclusion Criteria
- all patients >18 years
- traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater)
- quantitative wound culture < 105.
Exclusion Criteria
- Wounds that cannot have a negative pressure wound device applied due to anatomical difficulty (i.e. proximity to perineum/anus) or exposed arteries/veins.
- Patients who are DNR/DNI
- Patients who are hemodynamically unstable or requiring pressors
- Patients that are immunodeficient or immunocompromised (ie HIV)
- Patients that have any allergy to porcine products
- Patients that have a religious or ethical necessity to avoid porcine products
- Patients whose wounds are derived from extension of mitotic lesions (ie ulcerative squamous cell carcinoma)
- Patients whose wounds are expected to heal in less than seven days or be ready for skin grafting in less than seven days with standard therapy
- Patients with full thickness burns
- Patients with wound surface area of <50 sq cm
- Pregnant patients (as confirmed by serum or urinary beta-Human Chorionic Gonadotrophin sampling or by History).
Data sourced from ClinicalTrials.gov (NCT01848821). 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.