Magen Haim Project - Assessing Hand Hygiene Formulas

Comparing Use of Hand Hygiene Products Clinical Trial

Official title:

Magen Haim Project - Assessing Hand Hygiene Formulas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03188549
• Other study ID #: SHEBA-17-3882-GR-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2017
• Last updated: October 16, 2017
• Start date: June 15, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: June 2017
• Source: Sheba Medical Center
• Contact: Gili Regev-Yochay, MD
• Phone: 0526666197
• Email: gili.regev.y[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1505
• Est. completion date: January 15, 2019
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All staff in the participating departments

Exclusion Criteria:

Related Conditions & MeSH terms

• Comparing Use of Hand Hygiene Products

Intervention

Other:
• AniosGel 85 NPC
Hand hygiene formula
• Softa-Man (Braun)
Hand hygiene formula
• Septol
alcohol-based hand rub

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of staff reporting satisfaction with hand hygiene formula in questionnaire	Satisfaction Questionnaire will be distributed and filled in three times during the study.	1 year
Primary	Percentage of proper hand hygiene compliance as determined by Chess Application	The Chess Program, an application designed for analyzing compliance, will be used by researchers to observe and record amounts of times that staff members comply or do not comply with proper hand hygiene protocols, and determine the percentage of times that staff complied with proper hand hygiene protocols out of all observations	1 year
Secondary	Hand Hygiene Formula Use	Measuring the amount of product used, amount of bottles per hospitalization bed according to department (an accepted surrogate model measurement of hand hygiene compliance).	1 year