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The study never started due to administrative reasons.
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| Name | Class |
|---|---|
| Kenall Manufacturing | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control arm will be surgical care according to usual practice with usual ambient lighting | |
| Treatment Arm | Experimental | The treatment arm will include surgical care according to usual practice with germicidal ambient lighting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Germicidal lighting | Device | Germicidal ambient lighting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day postoperative SSIs, superficial and/or deep. | 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). |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy W. Loftus, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29907449 | Background | 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. | |
| 29307750 | Background |
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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 will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Prospective Cohort Study
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Surveillance of other healthcare-associated infections (HAIs) |
| 1.6 years |
| 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. |
| 29966756 | Background | 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. |
| 30380384 | Background | 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. |
| 27267310 | Background | 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. |