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Clinical Trials/NCT04900298
NCT04900298
Recruiting
Not Applicable

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

Oregon Health and Science University1 site in 1 country40 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Wound Infection
Sponsor
Oregon Health and Science University
Enrollment
40
Locations
1
Primary Endpoint
Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brandon M Togioka

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits

Time Frame: 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 Outcomes

  • Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software.(30 days following surgery)
  • Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events(30 days following surgery)

Study Sites (1)

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