Surgical Wound InfectionESKAPENCT04900298
Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System
A study testing SafeHaven Automated Hand Hygiene Device in people with Surgical Wound Infection and Cross Infection, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Wound Infection, Cross Infection
- What is being tested?
- SafeHaven Automated Hand Hygiene Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Brandon M Togioka, MD, 503-494-4572, togioka@ohsu.edu
Sarah Feller, fellersa@ohsu.edu
About this study
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
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.
Read the 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.
- Conditions
- Surgical Wound Infection, Cross Infection
- Being tested
- SafeHaven Automated Hand Hygiene Device
- Medical subject headings
- Surgical Wound Infection, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeHaven Automated Hand Hygiene DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Use of SafeHaven hand hygiene system in the operating room Receives: Device: SafeHaven Automated Hand Hygiene Device |
| Control Arm | No intervention | Standard of care hand hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative Time, typically less than 12 hours
Secondary outcomes (2)
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.
Measured: 30 days following surgery
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
Measured: 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia-Pacific Consumer Products LP, University of Iowa, RDB Informatics
- Responsible party
- Principal investigator, Brandon M Togioka, Oregon Health and Science University
- Investigators
- Brandon M Togioka, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900298
- Sponsor's protocol ID
- 22966
- Acronym
- ESKAPE
- Status last verified
- Jun 2024
- First submitted
- 12 May 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04900298
- Acronym / sponsor ID
- ESKAPE / 22966
- Conditions
- Surgical Wound Infection, Cross Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Georgia-Pacific Consumer Products LP, University of Iowa, RDB Informatics
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: SafeHaven Automated Hand Hygiene DeviceUse of SafeHaven hand hygiene system in the operating room |
| Control Arm | No intervention | –Standard of care hand hygiene |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeHaven Automated Hand Hygiene DeviceAnesthesia 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. | Device | Intervention Arm |
Primary outcome
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.
2 secondary outcomes
Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software.
Time frame: 30 days following surgery
Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events
Time frame: 30 days following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon M Togioka, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeHaven Automated Hand Hygiene Device in people with Surgical Wound Infection and Cross Infection, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brandon M Togioka, MD (503-494-4572, togioka@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.