Impact of Germicidal Light

March 3, 2020 updated by: Randy Loftus, University of Iowa

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control arm will be surgical care according to usual practice with usual ambient lighting
Experimental: Treatment Arm
The treatment arm will include surgical care according to usual practice with germicidal ambient lighting
Device: Germicidal lighting
Germicidal ambient lighting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

Kenall Manufacturing

Investigators

  • Principal Investigator: Randy W. Loftus, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201901773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD related to the registered primary (S. aureus transmission dynamics) and secondary outcomes (healthcare-associated infections) will be shared freely with scientists who request them. The request process will require submission and review of a research proposal for data use by the PI (Loftus) and Indigo-Clean.

IPD Sharing Time Frame

IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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