MedTrace Logo

Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

NCT02615379 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-08-14

No results posted yet for this study

Summary

EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Conditions

  • Instrumented Spinal Fusion

Interventions

DEVICE

EPIFLO

Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.

Sponsors & Collaborators

  • Neogenix, LLC dba Ogenix

    lead INDUSTRY

Principal Investigators

  • Nestor Tomycz, M.D. · Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-12-31
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02615379 on ClinicalTrials.gov