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

Instrumented Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02615379
• Other study ID #: EPF-515
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2015
• Last updated: August 10, 2017
• Start date: July 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2017
• Source: Neogenix, LLC dba Ogenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Instrumented Spinal Fusion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Department of Neurological Surgery Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Neogenix, LLC dba Ogenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months
Secondary	Severity of infection	Severity of infection - Superficial or deep as per CDC classification as assessed by investigator	3 months