Clinical trial NCT02615379: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Instrumented Spinal Fusion
Keywords: instrumented spinal fusion
infection
topical oxygen
Lead sponsor: Neogenix, LLC dba Ogenix
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 3 months
Secondary outcomes:
measure: Resource utilization
timeFrame: 3 months
measure: Severity of infection
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Department of Neurological Surgery Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Department of Neurosurgery
name: Nestor Tomycz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: