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| Name | Class |
|---|---|
| Texas Orthopedic Hospital | UNKNOWN |
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The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
The Air Barrier System (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 CFU and particles at the surgery site during total arthroplasty surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | In the control arm, the ABS device will be placed as usual on the patient, but the airflow will NOT be activated. Only the technician in the room will be aware whether the device the device is turned on or not. |
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| Air Barrier System | Experimental | In the experimental (interventional) arm, the ABS device will be placed as usual on the patient, and the airflow will be activated. Only the technician in the room will be aware whether the device is turned on or not. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Device | The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator. |
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| Measure | Description | Time Frame |
|---|---|---|
| CFU counts | Inter-arm comparison of CFU counts taken during both the Control arm and ABS arm | Four months |
| Particle counts | Inter-arm comparison of particle counts taken during both the Control arm and ABS arm. | Four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Stocks, MD | Contact | 713-799-8600 | stocks@fondren.com | |
| Sean Self | Contact | 284-565-5715 | self@nimbicsystems.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Stocks, MD | Texas Orthopedic Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19913327 | Background | Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Air Barrier System | Device | The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |