Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)

NCT ID: NCT02605499

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-02-28

Brief Summary

This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria.

Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.

Detailed Description

Effective cleaning of the patient environment (the patient room during hospital stay) is subject to human factors and unfortunately is often inconsistent or inadequate. Patient rooms that have residual bacteria after routine environmental cleaning can act as reservoirs for multidrug-resistant organisms (MDROs) and contribute to the spread of MDROs from patient to patient. In the setting of an increased focus on Healthcare-associated Infections such as Clostridium difficile (C. difficile) and multidrug-resistant Gram negative and Gram positive organisms such as carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphlococcus aureus (MRSA), Ultra-Violet C (UV-C) light has been shown to be a safe, effective way to decrease the burden of MDROs in patient rooms. However, studies examining the effectiveness of UV-C light when used post daily and discharge patient room cleaning are lacking.

This study is a cluster, randomized, two-period cross over trial to investigate the relationship between environmental decontamination with UV-C light and transmission of VRE and other healthcare-associated bacteria. It investigates the hypothesis that UV-C in addition to daily cleaning leads to decreased patient acquisition of healthcare-associated bacteria.

This study is important to further advance hospital-based infection prevention knowledge of the impact of UV-C light for environmental cleaning.

Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.

Conditions

Healthcare Associated Infection; Multidrug Resistant Organisms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

UV-C light disinfection

During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

Group Type: EXPERIMENTAL

UV-C light disinfection

Intervention Type: OTHER

UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

Control

During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UV-C light disinfection

UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient rooms in pre-selected hospital units within Johns Hopkins Hospital

Exclusion Criteria

• None, intervention is at level of the hospital unit, not the patient

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Maragakis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

Rock C, Hsu YJ, Curless MS, Carroll KC, Ross Howard T, Carson KA, Cummings S, Anderson M, Milstone AM, Maragakis LL. Ultraviolet-C Light Evaluation as Adjunct Disinfection to Remove Multidrug-Resistant Organisms. Clin Infect Dis. 2022 Aug 24;75(1):35-40. doi: 10.1093/cid/ciab896.

Reference Type: DERIVED

PMID: 34636853 (View on PubMed)

Other Identifiers

IRB00063160

Identifier Type: -

Identifier Source: org_study_id