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Impact of Germicidal Light

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ClinicalTrials.gov Identifier: NCT03886337
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Kenall Manufacturing
Information provided by (Responsible Party):
Randy Loftus, 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.

Condition or disease Intervention/treatment Phase
Bacterial Transmission S.Aureus Transmission Operating Room Exposure to S. Aureus 90-day Postoperative Surgical Site Infections, Superficial and Deep Device: Germicidal lighting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Cohort Study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Germicidal Light on Intraoperative S. Aureus Exposure
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 90-day postoperative SSIs, superficial and/or deep. [ Time Frame: 1.6 years ]
    surveillance of wound infections, superficial and deep

  2. 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)



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886337


Contacts
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Contact: Randy W Loftus, MD 319-467-6795 randy-loftus@uiowa.edu
Contact: Joshua D Godding, BA 320-223-1454 joshua-godding@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Kenall Manufacturing
Investigators
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Principal Investigator: Randy W. Loftus, MD University of Iowa

Publications:

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Responsible Party: Randy Loftus, Associate Professor of Anesthesia and Critical Care Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT03886337     History of Changes
Other Study ID Numbers: 201901773
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Randy Loftus, University of Iowa:
Germicidal lights
S. aureus
Transmission
Operating room S. aureus exposure
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes