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

Not Applicable

• Conditions: Pathogen Transmission
• Interventions: Device: 405nm light

• Registration Number: NCT04264715
• Lead Sponsor: Northwestern Medicine

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 824

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Staphylococcus aureus transmission rate	sequential surgeries on the same 1 day	We will be assessing the transmission of bacteria to the patient during the case and from previous cases to subsequent cases.

Trial Locations

Locations (1)

Northwestern Lake Forest Hospital; 🇺🇸 Lake Forest, Illinois, United States