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

Not Applicable

Terminated

• Conditions: Septicemia

• Registration Number: NCT02093494
• Lead Sponsor: Magnolia Medical Technologies, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults >19 years old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluate the occurrence of any 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. 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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States