CClinicalTrials.gg
Status unknownNCT04264715Updated Feb 12, 2020

Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure

An interventional study of 405nm light in Pathogen Transmission, sponsored by Northwestern Medicine. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Northwestern Medicine · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
824
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Pathogen Transmission
03

In context

Lead sponsor

Northwestern Medicine is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Operating Rooms with and without the bactericidal lights where adult patients undergoing orthopedic, cardiothoracic, gynecology/oncology, and neurological surgery.

Exclusion criteria

Exclusion Criteria:

  • Operating Rooms with and without the bactericidal lights where pediatric, incarcerated, and/or pregnant patients undergoing surgery outside of the classifications above.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
824 participants (estimated)

Study arms

  • Experimental
    405nm light room

    In this room, surgeries will be performed under ambient light including the wavelength 405nm

    Device: 405nm light

  • No intervention
    Control room

    In this room, surgeries will be performed under ambient light from regular phosphorescent light does not include 405nm frequencies

Interventions

  • Device405nm light

    In this room, surgeries will be performed under ambient light including the wavelength 405nm

06

What researchers measure

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.

    Time frame: sequential surgeries on the same 1 day

07

Study locations

1 of 1 sites recruiting
  • Northwestern Lake Forest Hospital
    Lake Forest, Illinois 60045, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04264715
Lead sponsor
Northwestern Medicine
Responsible party
Andrew Gostine, MD (Anesthesiologist and Intensivist, Northwestern Medicine) — Principal investigator
First posted
Feb 11, 2020
Start date
Jan 6, 2020
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Feb 12, 2020

Study contacts

Andrew Gostine, MD, MBA
Contact
andrew.gostine@nm.org
312-695-0061

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion