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Impact of Germicidal Light

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03886337
Enrollment
0
Registered
2019-03-22
Start date
2022-05-01
Completion date
2024-12-31
Last updated
2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Germicidal lights, S. aureus, Transmission, Operating room S. aureus exposure

Brief summary

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

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.

Interventions

DEVICEGermicidal lighting

Germicidal ambient lighting

Sponsors

Kenall Manufacturing
CollaboratorOTHER
University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective Cohort Study

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.Approximately 103 work daysOR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed

Secondary

MeasureTime frameDescription
90-day postoperative SSIs, superficial and/or deep.1.6 yearssurveillance of wound infections, superficial and deep
90-day HAIs (combined incidence of SSIs, respiratory, blood stream, catheter-associated urinary tract, and C. Difficile infections).1.6 yearsSurveillance of other healthcare-associated infections (HAIs)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026