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

Pathogen Transmission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04264715
• Other study ID #: 19-044
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Northwestern Medicine
• Contact: Andrew Gostine, MD, MBA
• Phone: 312-695-0061
• Email: andrew.gostine[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 824
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pathogen Transmission

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Lake Forest Hospital	Lake Forest	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	sequential surgeries on the same 1 day