Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters

N/ATerminatedNCT02093494

Magnolia Medical Technologies, Inc.200 enrolled

Overview

This is a randomized, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Septicemia

Interventions

Outcomes

Primary Outcomes

Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC

Time frame: Baseline

Secondary Outcomes

Evaluate the occurrence of any adverse device effects

As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device. Any issues with the function of the device will be reported by the phlebotomist on a device incident form. The sponsor will maintain these reports in a database. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.