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| Name | Class |
|---|---|
| Georgia-Pacific Consumer Products LP | UNKNOWN |
| University of Iowa | OTHER |
| RDB Informatics | UNKNOWN |
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The investigators hypothesize that the use of a personal hand hygiene system (SafeHavenTM) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (OR PathTrac) will decrease participant exposure to pathologic bacteria in the adult operating room.
This will be a prospective, single center, unmasked, controlled before and after study.
Intervention Arm: Use of SafeHaven hand hygiene system in the operating room
Control Arm: Standard of care hand hygiene
Operating Room Selection: Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for detection of pathogenic bacteria. The operating room for investigation will be randomly selected through the following process:
The goal of the study is to map transmission of bacteria through the operating room and compare mapping with the SafeHaven Hand Hygiene system to mapping without the SafeHaven Hand Hygiene system. Thus, case-pairs will be randomized to the same assignment. For example, subject 1 and 2 will have surgery in South Operating Room 8 and both will be randomized to the control group. The first 10 case-pairs will be assigned to the control arm and the second 10 case-pairs will be assigned to the intervention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Use of SafeHaven hand hygiene system in the operating room |
|
| Control Arm | No Intervention | Standard of care hand hygiene |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeHaven Automated Hand Hygiene Device | Device | Anesthesia providers in the intervention arm will be given a personal hand hygiene device, containing 64% ethyl alcohol, which provides actionable real-time performance feedback. The personalized device will be affixed to the provider's waist and will remain there for use throughout the perioperative period. Performance feedback is given to the anesthesia provider in real time with the number of personal hand hygiene events and an hourly hand hygiene rate, which is displayed on the device. Devices will be handed out to participating providers in the preoperative bay and retrieved in the post-anesthesia care unit upon case completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits | The following reservoirs will be cultured at case start (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant) and at case end (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant, and internal lumen of intravenous tubing stopcock) within the operating room suite using a sterile collection kit. | Perioperative Time, typically less than 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software. | OR Path Trac software algorithms will map how ESKAPE pathogens are transmitted from an initially identified reservoir to a new location within the perioperative environment. | 30 days following surgery |
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Patient Inclusion Criteria:
Patients ≥ 18 years of age having surgery in an adult operating suite at the research center involving the following specialties: orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, and open urological, general abdominal, acute care, cardiothoracic, and plastic/breast.
Patient Exclusion Criteria:
Anesthesia Provider Inclusion Criteria:
• Faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center.
Anesthesia Provider Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandon M Togioka, MD | Contact | 503-494-4572 | togioka@ohsu.edu | |
| Sydney Rose, MD | Contact | 503-494-1358 | rosesy@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brandon M Togioka, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
There is no plan to share individual participant data with other researchers.
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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This will be a prospective, single center, unmasked, controlled before and after study. Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for the detection of pathogenic bacteria. The first twenty patients (10 case-pairs) will be enrolled in the control (standard care) arm followed by 20 patients (10 case-pairs) being enrolled in the intervention (SafeHaven) arm.
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| Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events | Compare the reduction in ESKAPE transmission events for patients who receive standard of care versus patients who have anesthesia providers that use the SafeHaven personal hand hygiene device | 30 days following surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |