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

Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients
with SSI after instrumented spinal surgery often require repeat operations and prolonged
intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism
behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently
become a novel strategy to facilitate wound healing.

The study doctor will give an EPIFLO® unit along with standard wound care to some subjects
in this study to see if it is safe and can help them. Another purpose of this study is to
find out if using EPIFLO® is better than getting only standard wound care for Surgical site
infections (SSI). The sponsor also wants to compare the cost of using the study device and
standard wound care to the cost of standard wound care alone. The U.S. Food and Drug
Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin
ulcers), bedsores, amputations, skin grafts, burns, and frostbite.

Inclusion Criteria:

- 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

Exclusion Criteria:

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