Recruiting

Indigo-Clean

Sponsor:

Northwestern Medicine

Code:

NCT04264715

Conditions

Pathogen Transmission

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

405nm light

Study Details

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).

Conditions

Pathogen Transmission

Study ID

NCT04264715

Start date

Jan 6, 2020

Status verified date

Feb, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

824 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 405nm light room

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

no intervention: Control room

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

Interventions

405nm light

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

Primary outcome measure

  • Staphylococcus aureus transmission rate [ Time Frame: sequential surgeries on the same 1 day ]

Central Contacts and Locations

Central contacts

Andrew Gostine, MD, MBA

312-695-0061andrew.gostine@nm.org

Locations

Northwestern Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Andrew Gostine, MD, MBA

312-695-0061andrew.gostine@nm.org

More Information

Sponsor

Northwestern Medicine

Last update posted

Feb 12, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern Medicine on 2020-02-12.