The Effect of OASIS Ultra on Critical Sized Wound Healing
|ClinicalTrials.gov Identifier: NCT01848821|
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : October 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Wound Infective Wound Iatrogenic Critical Sized Wound Defects Wound Healing||Device: OASIS Ultra Device: Wound VAC Standard Therapy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pilot Study of the Effect of OASIS Ultra on Critical Sized Wound Healing|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
OASIS half of wound
OASIS will be applied to one half of the wound and standard of care consisting of wound vac only will be applied to the other half.
Device: OASIS Ultra
Porcine derived intestinal submucosa
Standard therapy half of wound
Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application.
Device: Wound VAC Standard Therapy
Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound
Other Name: Negative Pressure Wound Device
- Wound size [ Time Frame: 60 days ]Wound size will be assessed by serial photography and surface area measurement.
- Wound healing quality [ Time Frame: 60 days ]serial wound edge biopsies will be obtained to assess vascularity, collagen deposition and cellularity of the wound edge in each arm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848821
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Daniel Dante Yeh, MD||Massachusetts General Hospital|