Impact of Germicidal Light

90-day Postoperative Surgical Site Infections, Superficial and Deep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03886337
• Other study ID #: 201901773
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Germicidal lighting
Germicidal ambient lighting

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Kenall Manufacturing

Country where clinical trial is conducted

United States, 

References & Publications (5)

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):888-95. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 103 work days
Secondary	90-day postoperative SSIs, superficial and/or deep.	surveillance of wound infections, superficial and deep	1.6 years
Secondary	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)	1.6 years