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.