Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
Primary Purpose
Instrumented Spinal Fusion
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EPIFLO
Sponsored by
About this trial
This is an interventional prevention trial for Instrumented Spinal Fusion focused on measuring instrumented spinal fusion, infection, topical oxygen
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
Sites / Locations
- Department of Neurological Surgery Allegheny General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transdermal Continuous Oxygen Therapy
Standard of care
Arm Description
EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care
standard wound care for 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Severity of infection
Severity of infection - Superficial or deep as per CDC classification as assessed by investigator
Full Information
NCT ID
NCT02615379
First Posted
November 18, 2015
Last Updated
August 10, 2017
Sponsor
Neogenix, LLC dba Ogenix
1. Study Identification
Unique Protocol Identification Number
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative reasons
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neogenix, LLC dba Ogenix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Instrumented Spinal Fusion
Keywords
instrumented spinal fusion, infection, topical oxygen
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be given blinded data and pictures to enable unbiased assessment.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transdermal Continuous Oxygen Therapy
Arm Type
Experimental
Arm Description
EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
standard wound care for 2 weeks
Intervention Type
Device
Intervention Name(s)
EPIFLO
Other Intervention Name(s)
TCOT, Transdermal Continuous Oxygen Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of surgical site infection
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Resource utilization
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
Time Frame
3 months
Title
Severity of infection
Description
Severity of infection - Superficial or deep as per CDC classification as assessed by investigator
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestor Tomycz, M.D.
Organizational Affiliation
Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurological Surgery Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
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