Instrumented Spinal Fusion
Conditions
Keywords
instrumented spinal fusion, infection, topical oxygen
Brief summary
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Detailed description
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.
Interventions
DEVICEEPIFLO
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
Neogenix, LLC dba Ogenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be given blinded data and pictures to enable unbiased assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical site infection | 3 months | The primary objective of this study is to assess surgical site infection within 3 months of surgery for high risk patients undergoing posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control. Surgical site infection will be clinically assessed by the PI according to CDC criteria. Independent blinded assessment by a clinician blinded to the allocation arm will also be obtained. The number of patients with infection (and the severity of infection) in the treated arm will be compared to the number in the control arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource utilization | 3 months | Resource utilization- the sum total of cost of treatments, hospital stays, bandages, nursing care and anything else related to treatment all measured in dollar amounts and then summed |
| Severity of infection | 3 months | Severity of infection - Superficial or deep as per CDC classification as assessed by investigator |
Countries
United States
Outcome results
None listed