Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

Not Applicable

Completed

• Conditions: Septicemia
• Interventions: Device: Initial Specimen Diversion Device (ISDD); Device: Lab standard practice (LSP)

• Registration Number: NCT02102087
• Lead Sponsor: Magnolia Medical Technologies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-30
• Study First Posted: 2014-04-02
• Study Start: 2014-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

Inclusion Criteria

• Adults >19 years old

Exclusion Criteria

• Not a good candidate for direct-to-media (DTM) technique

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Initial Specimen Diversion Device (ISDD)	Initial Specimen Diversion Device (ISDD)	The ISDD will be used in conjunction with standard blood culture bottles.
Lab standard practice (LSP)	Lab standard practice (LSP)	A standard blood culture kit will be used.

Primary Outcome Measures

Name	Time	Method
Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)	Baseline	Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.

Secondary Outcome Measures

Name	Time	Method
Occurrence rate of adverse device effects	Baseline	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, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States