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

N

Northwestern Medicine

Status

Unknown

Conditions

Pathogen Transmission

Treatments

Device: 405nm light

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

824 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

824 participants in 2 patient groups

405nm light room
Experimental group
Description:
In this room, surgeries will be performed under ambient light including the wavelength 405nm
Treatment:
Device: 405nm light
Control room
No Intervention group
Description:
In this room, surgeries will be performed under ambient light from regular phosphorescent light does not include 405nm frequencies

Trial contacts and locations

1

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Central trial contact

Andrew Gostine, MD, MBA

Data sourced from clinicaltrials.gov

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