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

Neogenix, LLC dba Ogenix

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Instrumented Spinal Fusion

Interventions

EPIFLODEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurological Surgery Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

Severity of infection

Severity of infection - Superficial or deep as per CDC classification as assessed by investigator

Time frame: 3 months

Data from ClinicalTrials.gov

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