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

N

Neogenix

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Withdrawn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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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