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

Neogenix (Ogenix)

Status: Withdrawn

Conditions: Instrumented Spinal Fusion

Treatments: Device: EPIFLO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02615379

EPF-515

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Transdermal Continuous Oxygen Therapy

Experimental group

Description:

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

Treatment:

Device: EPIFLO

Standard of care

No Intervention group

Description:

standard wound care for 2 weeks