Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure
1 other identifier
interventional
824
1 country
1
Brief Summary
Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light (non-ultraviolet spectrum) at 405nm has been shown to be germicidal. We hypothesize that use of this light in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Visible light is safe for routine, continual exposure, and is less harmful than sunlight. We plan to install ambient, germicidal lighting in 4 operating rooms. This ambient light is not directly applied to patients (does not involve the surgical procedure lights). Patients will undergo surgery according to usual practice. We will conduct a case-control study where operating rooms with surgeries with the lights are matched to operating rooms with surgeries without lights. In Aim 1, 4 OR-pairs will be observed each day over an anticipated 103 working days for the primary outcome of S. aureus transmission events over a total minimum study period of 5.2 months (103 working days).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2020
CompletedFirst Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 12, 2020
February 1, 2020
12 months
February 9, 2020
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Staphylococcus aureus transmission rate
We will be assessing the transmission of bacteria to the patient during the case and from previous cases to subsequent cases.
sequential surgeries on the same 1 day
Study Arms (2)
405nm light room
EXPERIMENTALIn this room, surgeries will be performed under ambient light including the wavelength 405nm
Control room
NO INTERVENTIONIn this room, surgeries will be performed under ambient light from regular phosphorescent light does not include 405nm frequencies
Interventions
In this room, surgeries will be performed under ambient light including the wavelength 405nm
Eligibility Criteria
You may qualify if:
- Operating Rooms with and without the bactericidal lights where adult patients undergoing orthopedic, cardiothoracic, gynecology/oncology, and neurological surgery.
You may not qualify if:
- Operating Rooms with and without the bactericidal lights where pediatric, incarcerated, and/or pregnant patients undergoing surgery outside of the classifications above.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist and Intensivist
Study Record Dates
First Submitted
February 9, 2020
First Posted
February 11, 2020
Study Start
January 6, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share