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Trial record 74 of 10359 for:    Anti-Infective Agents AND Bacterial

Evaluation of Two Hand Hygiene Products in ICUs

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ClinicalTrials.gov Identifier: NCT02258412
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hand Hygiene Effectiveness
Interventions Drug: hand antiseptic with CHG and alcohol
Drug: Alcohol hand sanitizer foam
Enrollment 51
Recruitment Details Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital
Pre-assignment Details Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment
Arm/Group Title Alcohol + CHG First Alcohol Only First Patient
Hide Arm/Group Description Healthcare workers who received product with alcohol + CHG prior to product with alcohol only Healthcare workers who received product with alcohol only prior to product with alcohol + CHG Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
Period Title: Overall Study
Started 26 25 61
Completed 26 25 61
Not Completed 0 0 0
Arm/Group Title Alcohol + CHG First Alcohol Only First Patient Total
Hide Arm/Group Description Healthcare workers who received product with alcohol + CHG prior to product with alcohol only Healthcare workers who received product with alcohol only prior to product with alcohol + CHG Patients received no treatment, but were cared for by healthcare workers who enrolled in the study Total of all reporting groups
Overall Number of Baseline Participants 26 25 61 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 61 participants 112 participants
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Subject age was not recorded as it is not relevant to the study outcome
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 61 participants 112 participants
Female NA [1]  NA [1]  NA [1]  NA [2] 
Male NA [1]  NA [1]  NA [1]  NA [2] 
[1]
Subject gender was not recorded as it is not relevant to the study outcome
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 25 participants 61 participants 112 participants
26 25 61 112
1.Primary Outcome
Title Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas
Hide Description Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.
Time Frame On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alcohol Hand Sanitizer Foam Hand Antiseptic With CHG and Alcohol
Hide Arm/Group Description:

Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.

Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day

Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.

hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.

Overall Number of Participants Analyzed 51 51
Mean (95% Confidence Interval)
Unit of Measure: log(10) transformed CFU
2.17
(2.07 to 2.27)
1.81
(1.67 to 1.95)
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alcohol + CHG First Alcohol Only First Patient
Hide Arm/Group Description Healthcare workers who received product with alcohol + CHG prior to product with alcohol only Healthcare workers who received product with alcohol only prior to product with alcohol + CHG Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
All-Cause Mortality
Alcohol + CHG First Alcohol Only First Patient
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/61 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alcohol + CHG First Alcohol Only First Patient
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alcohol + CHG First Alcohol Only First Patient
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/61 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Research Specialist
Organization: 3M Health Care Business
Phone: 651-736-1578
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02258412     History of Changes
Other Study ID Numbers: EM-05-013218
First Submitted: September 17, 2014
First Posted: October 7, 2014
Results First Submitted: January 31, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017