Trial Outcomes & Findings for Evaluation of Two Hand Hygiene Products in ICUs (NCT NCT02258412)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

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

Results posted on

2024-10-23

Participant Flow

Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital

Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment

Participant milestones

Participant milestones
Measure	Alcohol + CHG First Healthcare workers who received product with alcohol + CHG prior to product with alcohol only	Alcohol Only First Healthcare workers who received product with alcohol only prior to product with alcohol + CHG	Patient Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
Overall Study STARTED	26	25	61
Overall Study COMPLETED	26	25	61
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Two Hand Hygiene Products in ICUs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol + CHG First n=26 Participants Healthcare workers who received product with alcohol + CHG prior to product with alcohol only	Alcohol Only First n=25 Participants Healthcare workers who received product with alcohol only prior to product with alcohol + CHG	Patient n=61 Participants Patients received no treatment, but were cared for by healthcare workers who enrolled in the study	Total n=112 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=93 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=27 Participants	NA years STANDARD_DEVIATION NA • n=483 Participants
Sex: Female, Male Female	NA Participants n=93 Participants	NA Participants n=4 Participants	NA Participants n=27 Participants	NA Participants n=483 Participants
Sex: Female, Male Male	NA Participants n=93 Participants	NA Participants n=4 Participants	NA Participants n=27 Participants	NA Participants n=483 Participants
Region of Enrollment United States	26 participants n=93 Participants	25 participants n=4 Participants	61 participants n=27 Participants	112 participants n=483 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Alcohol Hand Sanitizer Foam n=51 Participants 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 With CHG and Alcohol n=51 Participants 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.
Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas	2.17 log(10) transformed CFU Interval 2.07 to 2.27	1.81 log(10) transformed CFU Interval 1.67 to 1.95

Adverse Events

Alcohol + CHG First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alcohol Only First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient

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

Clinical Research Specialist

3M Health Care Business

Phone: 651-736-1578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60