A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Incidence of surgical site infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor will be given blinded data and pictures to enable unbiased assessment.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients with malnutrition as indicated by Pre-albumin value of <20
- •Chronic corticosteroid use
- •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
Arms & Interventions
Transdermal Continuous Oxygen Therapy
EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care
Intervention: EPIFLO (Device)
Standard of care
standard wound care for 2 weeks
Outcomes
Primary Outcomes
Incidence of surgical site infection
Time Frame: 3 months
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.
Secondary Outcomes
- Resource utilization(3 months)
- Severity of infection(3 months)