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Impact of Germicidal Light

Primary Purpose

Bacterial Transmission, S.Aureus Transmission, Operating Room Exposure to S. Aureus

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Germicidal lighting
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Transmission focused on measuring Germicidal lights, S. aureus, Transmission, Operating room S. aureus exposure

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment Arm

Arm Description

The control arm will be surgical care according to usual practice with usual ambient lighting

The treatment arm will include surgical care according to usual practice with germicidal ambient lighting

Outcomes

Primary Outcome Measures

S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.
OR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed

Secondary Outcome Measures

90-day postoperative SSIs, superficial and/or deep.
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).
Surveillance of other healthcare-associated infections (HAIs)

Full Information

First Posted
March 20, 2019
Last Updated
March 3, 2020
Sponsor
University of Iowa
Collaborators
Kenall Manufacturing
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1. Study Identification

Unique Protocol Identification Number
NCT03886337
Brief Title
Impact of Germicidal Light
Official Title
Evaluation of the Impact of Germicidal Light on Intraoperative S. Aureus Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study never started due to administrative reasons.
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Kenall Manufacturing

4. Oversight

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Transmission, S.Aureus Transmission, Operating Room Exposure to S. Aureus, 90-day Postoperative Surgical Site Infections, Superficial and Deep
Keywords
Germicidal lights, S. aureus, Transmission, Operating room S. aureus exposure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Cohort Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will be surgical care according to usual practice with usual ambient lighting
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
The treatment arm will include surgical care according to usual practice with germicidal ambient lighting
Intervention Type
Device
Intervention Name(s)
Germicidal lighting
Intervention Description
Germicidal ambient lighting
Primary Outcome Measure Information:
Title
S. aureus reservoir detection and/or epidemiologically-related transmission event in an OR observational unit.
Description
OR reservoirs will be surveyed for S. aureus isolation and epidemiologically-relatedness assessed
Time Frame
Approximately 103 work days
Secondary Outcome Measure Information:
Title
90-day postoperative SSIs, superficial and/or deep.
Description
surveillance of wound infections, superficial and deep
Time Frame
1.6 years
Title
90-day HAIs (combined incidence of SSIs, respiratory, blood stream, catheter-associated urinary tract, and C. Difficile infections).
Description
Surveillance of other healthcare-associated infections (HAIs)
Time Frame
1.6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy W. Loftus, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
29907449
Citation
Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.
Results Reference
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PubMed Identifier
29307750
Citation
Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
Results Reference
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PubMed Identifier
29966756
Citation
Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.
Results Reference
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PubMed Identifier
30380384
Citation
Magill SS, O'Leary E, Janelle SJ, Thompson DL, Dumyati G, Nadle J, Wilson LE, Kainer MA, Lynfield R, Greissman S, Ray SM, Beldavs Z, Gross C, Bamberg W, Sievers M, Concannon C, Buhr N, Warnke L, Maloney M, Ocampo V, Brooks J, Oyewumi T, Sharmin S, Richards K, Rainbow J, Samper M, Hancock EB, Leaptrot D, Scalise E, Badrun F, Phelps R, Edwards JR; Emerging Infections Program Hospital Prevalence Survey Team. Changes in Prevalence of Health Care-Associated Infections in U.S. Hospitals. N Engl J Med. 2018 Nov 1;379(18):1732-1744. doi: 10.1056/NEJMoa1801550.
Results Reference
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PubMed Identifier
27267310
Citation
Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.
Results Reference
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Impact of Germicidal Light

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