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

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

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

Conditions
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Instrumented Spinal Fusion

Intervention / Treatment
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* Device: EPIFLO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Continuous Oxygen Therapy<br>EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care | Device: EPIFLO<br>* 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.<br>* Other names: TCOT, Transdermal Continuous Oxygen Therapy;|
| No Intervention: Standard of care<br>standard wound care for 2 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource utilization | 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 | 3 months | 
| Severity of infection | Severity of infection - Superficial or deep as per CDC classification as assessed by investigator | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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instrumented spinal fusion, infection, topical oxygen