Expired Study
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Pittsburgh, Pennsylvania 15212


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT02615379


Primary Contact:

Principal Investigator
Nestor Tomycz, M.D.
Department of Neurosurgery


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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