## Protocol Section
### Identification Module
**NCT ID:** NCT02615379

**Brief Title:** Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

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

#### Organization Study ID Info
**ID:** EPF-515
#### Organization
**Class:** INDUSTRY
**Full Name:** Neogenix, LLC dba Ogenix
### Status Module
#### Completion Date
**Date:** 2019-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-14

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-10

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2017-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2015-11-26
**Type:** ESTIMATED
**Study First Submit Date:** 2015-11-18
**Study First Submit QC Date:** 2015-11-24
**Why Stopped:** Administrative reasons
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Neogenix, LLC dba Ogenix

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Instrumented Spinal Fusion

**Keywords:**

- instrumented spinal fusion

- infection

- topical oxygen

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The outcomes assessor will be given blinded data and pictures to enable unbiased assessment.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care

**Intervention Names:**

- Device: EPIFLO

**Label:** Transdermal Continuous Oxygen Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** standard wound care for 2 weeks

**Label:** Standard of care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transdermal Continuous Oxygen Therapy

**Description:** 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.

**Name:** EPIFLO

**Other Names:**

- TCOT, Transdermal Continuous Oxygen Therapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Incidence of surgical site infection

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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

**Measure:** Resource utilization

**Time Frame:** 3 months

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

**Measure:** Severity of infection

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pittsburgh

**Country:** United States

**Facility:** Department of Neurological Surgery Allegheny General Hospital

**State:** Pennsylvania

**Zip:** 15212

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Neurosurgery

**Name:** Nestor Tomycz, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

### Misc Info Module

- Version Holder: 2024-05-24
