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

NCT ID: NCT02615379

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-03-31

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

Instrumented Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Transdermal Continuous Oxygen Therapy

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

Group Type: EXPERIMENTAL

EPIFLO

Intervention Type: 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.

Standard of care

standard wound care for 2 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EPIFLO

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.

Intervention Type: DEVICE

Other Intervention Names

TCOT, Transdermal Continuous Oxygen Therapy

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neogenix, LLC dba Ogenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nestor Tomycz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery

Locations

Department of Neurological Surgery Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

EPF-515

Identifier Type: -

Identifier Source: org_study_id