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

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Cross Infection; Surgical Wound Infection

Treatments: Device: SafeHaven Automated Hand Hygiene Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04900298

22966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Use of SafeHaven hand hygiene system in the operating room

Treatment:

Device: SafeHaven Automated Hand Hygiene Device

Control Arm

No Intervention group

Description:

Standard of care hand hygiene