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

Withdrawn before enrolling · Not applicable

Conditions studied: Instrumented Spinal Fusion

In brief

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

Key facts

Study ID

NCT02615379

Run by

Neogenix, LLC dba Ogenix

People needed

0

Starts

2017-07-01

Expected to finish

2019-03-31

Last updated by the study team

2017-08-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions
• Patient Age 18-80
• Patients must be considered high risk for infection, meeting one or more of the following criteria:
• Anticipated Surgical duration ≥ 3 hours
• Diabetes Mellitus type I or II
• Anesthesiology ASA score of 3 or above
• BMI ≥35
• Patients with malnutrition as indicated by Pre-albumin value of <20
• Chronic corticosteroid use
• Smokers
• Patients on immune modulators

You may not qualify if…

• Major Study Exclusion Criteria include:
• Pregnancy
• Active infection at the time of surgery
• Persons with decubitus or diabetic ulcers
• Patients undergoing >5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion)
• Disseminated Cancer Patients

Where it is running

• Department of Neurological Surgery Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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