Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900298
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-05-12
Brief Title:
Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Reducing Intraoperative ESKAPE Enterococcus S Aureus Klebsiella Acinetobacter Pseudomonas and Enterobacter Spp Transmission in the Adult Operating Room Via Use of a Personal Hand Hygiene System Optimized by OR PathTrac
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESKAPE
Brief Summary:
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
Detailed Description:
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
1 All the operating rooms with scheduled surgeries in the South Operating Rooms on a particular day will be entered into a random number generator example operating rooms 2 3 5 7
2 The random generator will sort these operating rooms into a rank list example operating rooms 5 3 2 7
3 The investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found example operating room 5 only has one surgery operating room 3 has pediatric surgery operating room 2 meets inclusion criteria
4 This process will be duplicated for each case-pair
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
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
1 All the operating rooms with scheduled surgeries in the South Operating Rooms on a particular day will be entered into a random number generator example operating rooms 2 3 5 7
2 The random generator will sort these operating rooms into a rank list example operating rooms 5 3 2 7
3 The investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found example operating room 5 only has one surgery operating room 3 has pediatric surgery operating room 2 meets inclusion criteria
4 This process will be duplicated for each case-pair
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None