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The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No device | No Intervention | Subject does not receive ABS system | |
| Air Barrier System device | Experimental | Device is deployed adjacent to the surgery site and activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air Barrier System device | Device | Device is deployed adjacent to the surgery site and activated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CFU Density | Colony-forming unit density at incision site (CFU/m3) | Surgical case CFU density will be determined at up to 1 month from completion of surgical cases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabih O Darouiche, MD | Baylor College of Medicine | Principal Investigator |
| Sean Self | Nimbic Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Device | Subject does not receive ABS system |
| FG001 | Air Barrier System Device | Device is deployed adjacent to the surgery site and activated. Air Barrier System device: Device is deployed adjacent to the surgery site and activated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Device | Subject does not receive ABS system |
| BG001 | Air Barrier System Device | Device is deployed adjacent to the surgery site and activated. Air Barrier System device: Device is deployed adjacent to the surgery site and activated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CFU Density | Colony-forming unit density at incision site (CFU/m3) | Posted | Mean | 95% Confidence Interval | CFU/m^3 | Surgical case CFU density will be determined at up to 1 month from completion of surgical cases |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Device | Subject does not receive ABS system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Self | Nimbic Systems | 281-565-5715 | self@nimbicsystems.com |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Air Barrier System Device | Device is deployed adjacent to the surgery site and activated. Air Barrier System device: Device is deployed adjacent to the surgery site and activated. | 0 | 18 | 0 | 18 |
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