Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System

Sponsor
Oregon Health and Science University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04900298
Collaborator
Georgia-Pacific Consumer Products LP (Other), University of Iowa (Other), RDB Informatics (Other)
40
1
2
24
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SafeHaven Automated Hand Hygiene Device
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Arm

Use of SafeHaven hand hygiene system in the operating room

Device: SafeHaven Automated Hand Hygiene 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.

No Intervention: Control Arm

Standard of care hand hygiene

Outcome Measures

Primary Outcome Measures

  1. Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits [Perioperative Time, typically less than 12 hours]

    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.

Secondary Outcome Measures

  1. Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software. [30 days following surgery]

    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.

  2. Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events [30 days following surgery]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • Patients with a known infection at the time of surgery.

  • Prisoners

  • Pregnant Women

  • Patients lacking capacity to consent

  • Patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol

  • Refusal of consent

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:
  • Refusal of consent

  • Open sores of the hands

  • Known skin infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health and Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University
  • Georgia-Pacific Consumer Products LP
  • University of Iowa
  • RDB Informatics

Investigators

  • Principal Investigator: Brandon M Togioka, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brandon M Togioka, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT04900298
Other Study ID Numbers:
  • 22966
First Posted:
May 25, 2021
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022