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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Specimen Diversion Device (ISDD) | Experimental | The ISDD will be used to collect the blood culture. |
|
| Lab standard practice (LSP) | Active Comparator | The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Specimen Diversion Device (ISDD) | Device |
| ||
| Lab standard practice (LSP) |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Patton, M.D. | Magnolia Medical Technologies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| Procedure |
|
| Peripheral Intravenous Catheters (PIVC) | Device |
|
| Baseline |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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