Comparing Use of Hand Hygiene ProductsPhase 4NCT03188549
Magen Haim Project - Assessing Hand Hygiene Formulas
A Phase 4 study testing AniosGel 85 NPC, Softa-Man (Braun) and Septol in people with Comparing Use of Hand Hygiene Products, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Comparing Use of Hand Hygiene Products
- What is being tested?
- AniosGel 85 NPC, Softa-Man (Braun) and Septol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,505 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2017to 15 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All staff in the participating departments
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 5265601
Gili Regev-Yochay, 0526666197
About this study
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.
Read more
The investigators will assess
- Satisfaction of staff.
- Increase of hand hygiene compliance.
Read the detailed 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:
- At point zero (while still using Septol), distribute a questionnaire of hand hygiene compliance and satisfaction.
- 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).
- Exchange antiseptic Septol with the trial product in departments of Branch A and Branch B for the first six months (Stage I).
- At point one (six months into the study), distribute a questionnaire of hand hygiene compliance and satisfaction.
- Interim analysis of the questionnaires from point zero and point one.
- Instruction to departments regarding the switch of products, regarding the use of the new product.
- Exchange of trial product between the two groups for the second six month period (Stage II).
- At point two (twelve months into the study), distribute a questionnaire of hand hygiene compliance and satisfaction.
- Final analysis of questionnaires from Point 0, 1, and 2, as well as compliance of hand hygiene.
- Conditions
- Comparing Use of Hand Hygiene Products
- Being tested
- AniosGel 85 NPC, Softa-Man (Braun), Septol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AniosGel 85 NPCOther
Hand hygiene formula
Softa-Man (Braun)Other
Hand hygiene formula
SeptolOther
alcohol-based hand rub
| Study group | Role | What they receive |
|---|---|---|
| Departments of Branch A | Active comparator | 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 Receives: Other: AniosGel 85 NPC |
| Departments of Branch B | Active comparator | 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 Receives: Other: Softa-Man (Braun) |
| Branch C | Active comparator | 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 Receives: Other: Septol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of staff reporting satisfaction with hand hygiene formula in questionnaire
Satisfaction Questionnaire will be distributed and filled in three times during the study.
Measured: 1 year
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
Measured: 1 year
Secondary outcomes (1)
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start15 Jun 2017
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing Use of Hand Hygiene ProductsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror Harats, Prof., Study chair, IRB Committee Sheba Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188549
- Sponsor's protocol ID
- SHEBA-17-3882-GR-CTIL
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magen Haim Project - Assessing Hand Hygiene Formulas
- ClinicalTrials.gov ID
- NCT03188549
- Acronym / sponsor ID
- SHEBA-17-3882-GR-CTIL
- Conditions
- Comparing Use of Hand Hygiene Products
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,505 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Satisfaction of staff.
- Increase of hand hygiene compliance.
Detailed 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:
- At point zero (while still using Septol), distribute a questionnaire of hand hygiene compliance and satisfaction.
- 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).
- Exchange antiseptic Septol with the trial product in departments of Branch A and Branch B for the first six months (Stage I).
- At point one (six months into the study), distribute a questionnaire of hand hygiene compliance and satisfaction.
- Interim analysis of the questionnaires from point zero and point one.
- Instruction to departments regarding the switch of products, regarding the use of the new product.
- Exchange of trial product between the two groups for the second six month period (Stage II).
- At point two (twelve months into the study), distribute a questionnaire of hand hygiene compliance and satisfaction.
- Final analysis of questionnaires from Point 0, 1, and 2, as well as compliance of hand hygiene.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Departments of Branch A | Active comparator | Other: AniosGel 85 NPCIntervention: 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 |
| Departments of Branch B | Active comparator | Other: Softa-Man (Braun)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 |
| Branch C | Active comparator | Other: SeptolControl 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All staff in the participating departments
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AniosGel 85 NPCHand hygiene formula | Other | Departments of Branch A |
| Softa-Man (Braun)Hand hygiene formula | Other | Departments of Branch B |
| Septolalcohol-based hand rub | Other | Branch C |
Primary outcome
Percentage of staff reporting satisfaction with hand hygiene formula in questionnaire
Time frame: 1 year
Satisfaction Questionnaire will be distributed and filled in three times during the study.
Percentage of proper hand hygiene compliance as determined by Chess Application
Time frame: 1 year
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 secondary outcome
Hand Hygiene Formula Use
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Harats, Prof. study chair
IRB Committee Sheba Medical Center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AniosGel 85 NPC, Softa-Man (Braun) and Septol in people with Comparing Use of Hand Hygiene Products, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gili Regev-Yochay, MD (0526666197, gili.regev.y@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of staff reporting satisfaction with hand hygiene formula in questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.