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

Primary Purpose

Surgical Wound Infection, Cross Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SafeHaven Automated Hand Hygiene Device
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Use of SafeHaven hand hygiene system in the operating room

Standard of care hand hygiene

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
May 12, 2021
Last Updated
April 20, 2022
Sponsor
Oregon Health and Science University
Collaborators
Georgia-Pacific Consumer Products LP, University of Iowa, RDB Informatics
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1. Study Identification

Unique Protocol Identification Number
NCT04900298
Brief Title
Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System
Acronym
ESKAPE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Georgia-Pacific Consumer Products LP, University of Iowa, RDB Informatics

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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: 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). The random generator will sort these operating rooms into a rank list (example: operating rooms 5, 3, 2, 7). 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Cross Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Use of SafeHaven hand hygiene system in the operating room
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard of care hand hygiene
Intervention Type
Device
Intervention Name(s)
SafeHaven Automated Hand Hygiene Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits
Description
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.
Time Frame
Perioperative Time, typically less than 12 hours
Secondary Outcome Measure Information:
Title
Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software.
Description
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.
Time Frame
30 days following surgery
Title
Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events
Description
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
Time Frame
30 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon M Togioka, MD
Phone
503-494-4572
Email
togioka@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Rose, MD
Phone
503-494-1358
Email
rosesy@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon M Togioka, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon M Togioka, MD
Phone
503-494-4572
Email
togioka@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Sarah Feller
Email
fellersa@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Brandon M Togioka, MD
First Name & Middle Initial & Last Name & Degree
Sydney Rose, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers.

Learn more about this trial

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

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