Instrumented Spinal Fusion Clinical Trial
Official title:
A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01982045 -
RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
|
N/A |