At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of the Effect of OASIS Ultra on Critical Sized Wound Healing
In Brief
A Phase 1 clinical trial evaluating OASIS Ultra and Wound VAC Standard Therapy for Traumatic Wound and 3 related conditions. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Porcine derived intestinal submucosa
Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound