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

NCT02615379 | Withdrawn DMC FDA Device

• 1 other identifier: EPF-515
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Instrumented Spinal Fusion

Keywords

instrumented spinal fusion; infection; topical oxygen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Resource utilization

  3 months

• Severity of infection

  3 months

Study Arms (2)

Transdermal Continuous Oxygen Therapy

EXPERIMENTAL

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

Device: EPIFLO

Standard of care

NO INTERVENTION

standard wound care for 2 weeks

Interventions

EPIFLO DEVICE

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.

Also known as: TCOT, Transdermal Continuous Oxygen Therapy

Transdermal Continuous Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neogenix, LLC dba Ogenix: lead

Study Sites (1)

Department of Neurological Surgery Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

• Nestor Tomycz, M.D.

  Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be given blinded data and pictures to enable unbiased assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2019
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

US (1)