Impact of Germicidal Light

Not Applicable

Withdrawn

• Conditions: S.Aureus Transmission; Operating Room Exposure to S. Aureus; Bacterial Transmission; 90-day Postoperative Surgical Site Infections, Superficial and Deep
• Interventions: Device: Germicidal lighting

• Registration Number: NCT03886337
• Lead Sponsor: University of Iowa

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-05
• Study Start: 2022-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult, at least 18 years old
• Adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access.

Exclusion Criteria

• Pediatric (<18 years old),
• Incarcerated, and/or
• Pregnant patients
• Undergoing surgery and/or without peripheral or central venous access.
• Undergoing surgery outside of the classifications above

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Germicidal lighting	The treatment arm will include surgical care according to usual practice with germicidal ambient lighting

Primary Outcome Measures

Name	Time	Method
S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.	Approximately 103 work days	OR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed

Secondary Outcome Measures

Name	Time	Method
90-day postoperative SSIs, superficial and/or deep.	1.6 years	surveillance of wound infections, superficial and deep
90-day HAIs (combined incidence of SSIs, respiratory, blood stream, catheter-associated urinary tract, and C. Difficile infections).	1.6 years	Surveillance of other healthcare-associated infections (HAIs)

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States