Trial Outcomes & Findings for Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection (NCT NCT03349268)
NCT ID: NCT03349268
Last Updated: 2022-03-14
Results Overview
PX-UV Device was used following each discharge on study units, with intervention devices emitting germicidal UV on 50% of the units and sham devices not emitting germicidal UV on 50% of the units.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25732 participants
Primary outcome timeframe
24 months (Two 12 month phases)
Results posted on
2022-03-14
Participant Flow
PX-UV Disinfection, real or sham, occurred in rooms after each patient discharge when the room is unoccupied, so there is no direct risk to the patient from PX-UV disinfection treatments. Patients' medical treatment was not impacted in any way, and there was no additional testing in the study. The IRB waived consent. There is no numerical difference between started and complete, because definitionally, any patient in an included room was counted and their data was used to determine eiHAIs.
Participant milestones
| Measure |
Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units
Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units
Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
Patients Cared for on Both PX-UV and Sham Units
Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable. As a results, they are assigned to this arm to explain their exclusion from each of the single treatment arms. It was not part of the original intention of the study to evaluate patients who were in both study environments.
Because these patients were exposed to both study environments, their outcomes could not be attributed to either study intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9117
|
10296
|
6319
|
|
Overall Study
COMPLETED
|
9117
|
10296
|
6319
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
Baseline characteristics by cohort
| Measure |
Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units
n=9117 Participants
Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units
n=10296 Participants
Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
Patients Cared for on Both PX-UV and Sham Units
n=6319 Participants
Despite the original study design where crossover occurred at the unit level, some patients were cared for on both a PX-UV unit as well as a Sham unit. The degree to which this occurred was unexpected, yet unavoidable.
|
Total
n=25732 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 18.23 • n=99 Participants
|
57.46 years
STANDARD_DEVIATION 18.41 • n=107 Participants
|
61.50 years
STANDARD_DEVIATION 16.51 • n=206 Participants
|
58.43 years
STANDARD_DEVIATION 17.98 • n=7 Participants
|
|
Sex/Gender, Customized
Female
|
4253 Participants
n=99 Participants
|
4962 Participants
n=107 Participants
|
3018 Participants
n=206 Participants
|
12233 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
4858 Participants
n=99 Participants
|
5333 Participants
n=107 Participants
|
3291 Participants
n=206 Participants
|
13482 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Unknown
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
31 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7142 Participants
n=99 Participants
|
8085 Participants
n=107 Participants
|
5212 Participants
n=206 Participants
|
20439 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
933 Participants
n=99 Participants
|
1025 Participants
n=107 Participants
|
419 Participants
n=206 Participants
|
2377 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported/Other
|
979 Participants
n=99 Participants
|
1130 Participants
n=107 Participants
|
655 Participants
n=206 Participants
|
2764 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
9117 participants
n=99 Participants
|
10296 participants
n=107 Participants
|
6319 participants
n=206 Participants
|
25732 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 months (Two 12 month phases)Population: It was not part of the original intention of the study to evaluate patients who were in both study environments. Because these patients were exposed to both study environments, their outcomes could not be attributed to either study intervention. Therefore the de facto "third arm" which accounts for them is not included in this analysis.
PX-UV Device was used following each discharge on study units, with intervention devices emitting germicidal UV on 50% of the units and sham devices not emitting germicidal UV on 50% of the units.
Outcome measures
| Measure |
Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units
n=86800 patient days
Pulsed xenon ultraviolet light (PX-UV) Device was used to disinfect rooms following post-discharge terminal cleaning: 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly within SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units
n=94154 patient days
Sham Device was run in rooms following post-discharge terminal cleaning. No Germicidal UV was emitted. 2 Detroit Medical Center (DMC) acute-care hospitals were proposed for this project, Sinai-Grace Hospital (SGH) with 383 beds and Detroit Receiving Hospital (DRH) with 248; 8 hospital units in SGH and 8 hospital units in DRH, including 2 medical intensive care units (ICUs), 2 surgical ICUs and 12 non-ICU medical-surgical wards.
Devices were deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) were assigned randomly to the units in Phase 1 and then switched in Phase 2.
|
|---|---|---|
|
Number of Environmentally-implicated Healthcare-Associated Infections (eiHAIs) Associated With the Additional Use of a PX-UV Disinfection Compared to Standard Terminal Cleaning
|
303 eiHAIs
|
298 eiHAIs
|
Adverse Events
Patients Only on Pulsed Xenon Ultraviolet Light (PX-UV) Device Emitting Germicidal UV Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Cared for on Only Sham Device - Non Emitting Germicidal UV Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Cared for on Both PX-UV and Sham Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place