NCT01579370

Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21,395 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Detailed description

Meticulous and consistent use of hand hygiene before and after patient care remains the cornerstone of infection prevention in all health care settings. However, clean hands are not sufficient to prevent all healthcare-associated infections (HAIs), as 1) hands of healthcare workers easily become contaminated from contact with contaminated environmental surfaces in patient rooms after appropriate hand hygiene has been performed and before direct patient care and 2) direct contact by patients with preexisting contaminated environmental surfaces in their hospital rooms can lead to colonization or infection. Thus, novel strategies are needed to prevent HAIs, particularly those caused by multidrug-resistant (MDR) pathogens that persist in the environment such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Clostridium difficile, and Acinetobacter. Enhanced environmental disinfection methods may lead to reduced risk of exposure to or acquisition of HAIs and MDR-pathogens and overcome a critical issue facing healthcare today - hospitals rooms are often poorly cleaned and disinfected. Enhanced terminal room disinfection strategies using bleach and/or UV-C emitting devices have been investigated only in experimental conditions; the efficacy, effectiveness, and feasibility of enhanced terminal room disinfection to prevent HAIs are unknown. Thus, the scientific evidence for such interventions currently is insufficient for their inclusion in evidence-based guidelines. This study will investigate the hypothesis that enhanced terminal room disinfection protocols (using chlorine-based cleaning agents with or without UV-C light-emitting devices) will decrease the overall risk of HAIs in the hospital and, more specifically, in subsequent patients who are cared for in the same room. This prospective investigation will employ a crossover design utilizing four room cleaning/disinfection protocols in 9 hospitals, including 2 tertiary care, 1 VA, and 6 community hospitals. Phase T2 data from this study will be useful in assessing the clinical efficacy and feasibility of individual disinfection strategies. Thus, the goals of the investigators proposed research are to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Conditions

• Multidrug Resistant Organisms
• Healthcare Associated Infections

Interventions

Type	Name	Description
OTHER	Quaternary ammonium	Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
OTHER	Bleach	Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
OTHER	Quaternary ammonium and UV-C light	Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
OTHER	Bleach and UV-C light	Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2015-08-01
• First posted: 2012-04-18
• Last updated: 2015-11-17

Locations

9 sites across 1 country: United States