NCT03886337

Impact of Germicidal Light

Evaluation of the Impact of Germicidal Light on Intraoperative S. Aureus Exposure

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

Detailed description

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light at 405nm has been shown to be germicidal. Investigators plan to install ambient, germicidal lighting (Indigo-Clean Lights) that uses this wavelength in 4 operating rooms. Patients will undergo surgery according to usual practice. Investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. Patients will be matched by procedure then case duration then American Society of Anesthesiologists (ASA) physical status health classification. These patients will undergo infection surveillance. Infection surveillance will involve use of National Healthcare Safety Network (NHSN) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (\>38.4 degrees Celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

Conditions

• Bacterial Transmission
• S.Aureus Transmission
• Operating Room Exposure to S. Aureus
• 90-day Postoperative Surgical Site Infections, Superficial and Deep

Interventions

Type	Name	Description
DEVICE	Germicidal lighting	Germicidal ambient lighting

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-03-22
• Last updated: 2020-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study