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Magen Haim Project - Assessing Hand Hygiene Formulas

NCT ID: NCT03188549

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Comparing Use of Hand Hygiene Products

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Departments of Branch A

Intervention: AniosGel Respiratory ICU Pediatric Cardiac Surgery, NICU Hemato-Oncology, Oncology Internal A, C, D, E, F Surgery C, Vascular Surgery and Chest Surgery Pediatric B South Imaging Orthopedics B

Group Type ACTIVE_COMPARATOR

AniosGel 85 NPC

Intervention Type OTHER

Hand hygiene formula

Departments of Branch B

Intervention: Softaman Neurosurgery ICU Cardiac Surgery, Cardiac ICU, Pediatric ICU Pediatric Hemato-Oncology Internal B and I, Geriatric C and D Surgery B Pediatric B North Emergency Room Orthopedics A and Hand

Group Type ACTIVE_COMPARATOR

Softa-Man (Braun)

Intervention Type OTHER

Hand hygiene formula

Branch C

Control Intervention - Septol without any changes All patients hospitalized in the 29 departments in Sheba, including two of the branches, during the year of the study

Group Type ACTIVE_COMPARATOR

Septol

Intervention Type OTHER

alcohol-based hand rub

Interventions

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AniosGel 85 NPC

Hand hygiene formula

Intervention Type OTHER

Softa-Man (Braun)

Hand hygiene formula

Intervention Type OTHER

Septol

alcohol-based hand rub

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All staff in the participating departments

Exclusion Criteria

* No
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dror Harats, Prof.

Role: STUDY_CHAIR

IRB Committee Sheba Medical Center Israel

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gili Regev-Yochay, MD

Role: CONTACT

Phone: 0526666197

Email: [email protected]

Ilana Tal, Nurse

Role: CONTACT

Phone: 035303372

Email: [email protected]

Facility Contacts

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Gili Regev-Yochay

Role: primary

Other Identifiers

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SHEBA-17-3882-GR-CTIL

Identifier Type: -

Identifier Source: org_study_id