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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)

Conditions
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Septicemia

Intervention / Treatment
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* Device: Initial Specimen Diversion Device (ISDD)
* Procedure: Lab standard practice (LSP)
* Device: Peripheral Intravenous Catheters (PIVC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >19 years old Exclusion Criteria: Not a good candidates for direct-to-media (DTM) technique

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial Specimen Diversion Device (ISDD)<br>The ISDD will be used to collect the blood culture. | Device: Initial Specimen Diversion Device (ISDD)<br> <br> |
| Active Comparator: Lab standard practice (LSP)<br>The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized. | Procedure: Lab standard practice (LSP)<br> <br> Device: Peripheral Intravenous Catheters (PIVC)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septicemia, Blood culture, Contamination