Status:
COMPLETED
The Effect of OASIS Ultra on Critical Sized Wound Healing
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Traumatic Wound
Infective Wound
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 investigat...
Detailed Description
The eligible participants for this study include all patients \>18 years with traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater) with a quantitative wound culture \<...
Eligibility Criteria
Inclusion
- all patients \>18 years
- traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater)
- quantitative wound culture \< 105.
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01848821
Start Date
May 1 2013
End Date
July 1 2015
Last Update
October 30 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114