Trial Outcomes & Findings for Hand Hygiene and Hospital Acquired Infections (NCT NCT02252562)
NCT ID: NCT02252562
Last Updated: 2019-02-18
Results Overview
Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.
COMPLETED
NA
3256 participants
30-day after surgery
2019-02-18
Participant Flow
Operating room enrollment occurred from September 30, 2013, to June 17, 2014, at Dartmouth-Hitchcock Medical Center and from January 8, 2014, to August 21, 2014, at UMass Memorial Medical Center. Five to 10 operating rooms were enrolled Monday-Friday for each of 20 working days per month at each site.
The randomization unit was the operating room (OR); not the patient or provider. Clinicians were educated on the purpose of the study and utilized standard practice or hand hygiene device based on the ORs. 316 clinicians utilizing the personal hand hygiene device were followed for assessment, but not enrolled.
Unit of analysis: Operating Rooms
Participant milestones
| Measure |
Standard Practice
Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
|
Personal Hand Hygiene Device
Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
|
|---|---|---|
|
Overall Study
STARTED
|
1620 1620
|
1636 1636
|
|
Overall Study
COMPLETED
|
1620 1620
|
1636 1636
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hand Hygiene and Hospital Acquired Infections
Baseline characteristics by cohort
| Measure |
Standard Practice
n=1620 Participants
Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
|
Personal Hand Hygiene Device
n=1636 Participants
Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
|
Total
n=3256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.29 years
STANDARD_DEVIATION 16.4 • n=99 Participants
|
56.75 years
STANDARD_DEVIATION 16.6 • n=107 Participants
|
57.02 years
STANDARD_DEVIATION 16.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
814 Participants
n=99 Participants
|
785 Participants
n=107 Participants
|
1599 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
806 Participants
n=99 Participants
|
851 Participants
n=107 Participants
|
1657 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1620 participants
n=99 Participants
|
1636 participants
n=107 Participants
|
3256 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30-day after surgeryPatients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.
Outcome measures
| Measure |
Standard Practice
n=1620 Participants
Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
|
Personal Hand Hygiene Device
n=1636 Participants
Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
|
|---|---|---|
|
Number of Participants With Postoperative Healthcare Acquired Infections
|
108 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of dischargePopulation: Data was not collected.
Readmission to the hospital within 30 days of discharge
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 30 Days of dischargePatient Mortality
Outcome measures
| Measure |
Standard Practice
n=1620 Participants
Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
|
Personal Hand Hygiene Device
n=1636 Participants
Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
|
|---|---|---|
|
Mortality
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 days after surgeryPopulation: Data was not collected
Duration of Hospital Stay
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During active OR casesPopulation: A control arm was not tabulated as the control group did not utilize the study device.
The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.
Outcome measures
| Measure |
Standard Practice
n=316 Participants
Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)
|
Personal Hand Hygiene Device
Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
Sage Personal Hand Hygiene System: Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
|
|---|---|---|
|
Hand Hygiene Events Per Hour Utilizing the Device
|
4.3 hand decontamination event per hour
Standard Deviation 2.9
|
—
|
Adverse Events
Standard Practice
Personal Hand Hygiene Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew D. Koff, MD Staff Physician, Anesthesiology
Dartmouth-Hitchcock Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place