Clinical Trials
Surgical Wound Healing
Lower Extremity
Revascularization
Incision
INTERVENTION / TREATMENT
Device: EPIFLO
STUDY START (ACTUAL)
2019-03-07
PRIMARY COMPLETION (ESTIMATED)
2022-07-31
STUDY COMPLETION (ESTIMATED)
2022-07-31
ENROLLMENT (ESTIMATED)
100
STUDY TYPE
Interventional
PHASE
Not Applicable
OTHER STUDY ID NUMBERS
EPF-418
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Oxygen Therapy Wounds and Injuries
Oxygen for Vascular Incisional Healing
ClinicalTrials.gov ID NCT03746132
Sponsor Neogenix, LLC dba Ogenix
Information provided by Neogenix, LLC dba Ogenix (Responsible Party)
Last Update Posted 2021-09-09
Study Overview
Brief Summary:
The purpose of this clinical trial is to evaluate Transdermal Continuous Oxygen Therapy (TCOT) as an adjunct to surgical wound healing in subjects undergoing vascular surgery for lower extremity arterial occlusive disease. It is the intention of this study to administer oxygen using the TCOT approach to the surgical sites of subjects undergoing the surgery and to monitor the healing of the incision as well as infection rate. The hypothesis is that oxygen delivered transdermally to the surgical site in a continuous manner for up to 28 days will accelerate the healing process and reduce the infection rate compared to the Standard of Care.