Impact of Germicidal Light

Study Overview
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Brief Summary
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Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

Detailed Description
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Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light at 405nm has been shown to be germicidal. Investigators plan to install ambient, germicidal lighting (Indigo-Clean Lights) that uses this wavelength in 4 operating rooms. Patients will undergo surgery according to usual practice. Investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. Patients will be matched by procedure then case duration then American Society of Anesthesiologists (ASA) physical status health classification. These patients will undergo infection surveillance. Infection surveillance will involve use of National Healthcare Safety Network (NHSN) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (>38.4 degrees Celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

Official Title
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Evaluation of the Impact of Germicidal Light on Intraoperative S. Aureus Exposure

Conditions
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Bacterial Transmission, S.Aureus Transmission, Operating Room Exposure to S. Aureus, 90-day Postoperative Surgical Site Infections, Superficial and Deep

Intervention / Treatment
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* Device: Germicidal lighting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, at least 18 years old Adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access. Exclusion Criteria: Pediatric (<18 years old), Incarcerated, and/or Pregnant patients Undergoing surgery and/or without peripheral or central venous access. Undergoing surgery outside of the classifications above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Cohort Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control arm will be surgical care according to usual practice with usual ambient lighting | |
| Experimental: Treatment Arm<br>The treatment arm will include surgical care according to usual practice with germicidal ambient lighting | Device: Germicidal lighting<br>* Germicidal ambient lighting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit. | OR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed | Approximately 103 work days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day postoperative SSIs, superficial and/or deep. | surveillance of wound infections, superficial and deep | 1.6 years | 
| 90-day HAIs (combined incidence of SSIs, respiratory, blood stream, catheter-associated urinary tract, and C. Difficile infections). | Surveillance of other healthcare-associated infections (HAIs) | 1.6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Germicidal lights, S. aureus, Transmission, Operating room S. aureus exposure