Comparing Use of Hand Hygiene Products Clinical Trial
Official title:
Magen Haim Project - Assessing Hand Hygiene Formulas
Background: Procedures of hand hygiene are an important component in prevention of
cross-transmission of infections in hospitals. In recent years, hand washing with antiseptic
soap (chlorhexidine) was replaced with use of alcohol-based hand rub. This change brought an
increase in compliance with hand hygiene regulations from 30-40% to over 50%, and in other
places up to 70%. However, even 70% compliance is not enough. One of the reported reasons for
lack of compliance of staff to the use of alcohol-based preparations is skin irritation and
dryness of the hands as a result of frequent use. At Sheba, like the majority of Israeli
hospitals, the product used for handwashing is Septol (Teva), which includes 0.5%
chlorhexidine gluconate (CHG) and 70% ethyl alcohol. The CDC, WHO and FDA guidelines approve
for use of hospital hand hygiene, products that contain between 61-85% ethanol.
The investigators will replace the Septol currently used with a different alcohol-based
antiseptic that is more user-friendly, and aim to determine whether this will increase the
compliance with hand hygiene protocols.
The investigators will assess
1. Satisfaction of staff.
2. Increase of hand hygiene compliance.
RESEARCH PATTERN:
Comparative research, Cross-Over, with a quasi-experimental component, comparing trial
products to the use of Septol over the course of the year before the research.
Included in the study will be 29 departments of Sheba, whilst the other hospital departments
will serve as a control group. The 29 departments will be divided into two branches with
similar departments in each (each branch consisting of 3 internal medicine departments, 3
urgent care departments, a pediatric department, a surgical department, etc.). In Stage I
(the initial six months), Branch A will exchange Septol with AniosGel, and Branch B will
exchange Septol with Softa-Man. In Stage II (the second six months), Branch A will change to
Softa-Man and Branch B will change to AniosGel. Branch C will be the control, where Septol
will be used throughout the duration of the study.
STUDY POPULATION:
For objectives 1 and 2: All medical staff at Sheba (in all 3 branches of the study).
Total: 15 Departments in Branch A, 14 Departments in Branch B
Stages of the Study:
1. At point zero (while still using Septol), distribute a questionnaire of hand hygiene
compliance and satisfaction.
2. Instruction to Branch A and Branch B departments regarding the switch of Septol to the
new product (instruction to staff in all sectors of these departments).
3. Exchange antiseptic Septol with the trial product in departments of Branch A and Branch
B for the first six months (Stage I).
4. At point one (six months into the study), distribute a questionnaire of hand hygiene
compliance and satisfaction.
5. Interim analysis of the questionnaires from point zero and point one.
6. Instruction to departments regarding the switch of products, regarding the use of the
new product.
7. Exchange of trial product between the two groups for the second six month period (Stage
II).
8. At point two (twelve months into the study), distribute a questionnaire of hand hygiene
compliance and satisfaction.
9. Final analysis of questionnaires from Point 0, 1, and 2, as well as compliance of hand
hygiene.
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