NCT02102087

Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 971 (actual)
• Sponsor: Magnolia Medical Technologies, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a matched, 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 peripheral venipuncture 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.

Conditions

• Septicemia

Interventions

Type	Name	Description
DEVICE	Initial Specimen Diversion Device (ISDD)
DEVICE	Lab standard practice (LSP)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-04-02
• Last updated: 2017-08-11

Locations

1 site across 1 country: United States