AntisepsisPhase 4NCT04683146
Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate ( Sorbectol )
A Phase 4 study testing Hand antisepsis with Propanolol- 1 60%. and Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. in people with Antisepsis, run by Centro Ortopedico y Quirurgico del Pie.
Trial summary
The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Antisepsis
- What is being tested?
- Hand antisepsis with Propanolol- 1 60%. and Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2021to 5 Jun 2021
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with healthy skin in both hands and short fingernails.
- No use of antibacterial agents for at least three days before the intervention.
- Not received antibiotic treatment for at least ten days before the intervention.
Who cannot join
- Known systemic pathologies
- Wearing hand jewelry on the hands
- Allergy to any ingredient of which the solutions used in the clinical trial are composed
- Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.
Read the detailed description
The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
- Conditions
- Antisepsis
- Being tested
- Hand antisepsis with Propanolol- 1 60%., Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand antisepsis with Propanolol- 1 60%.Drug
- Pre-washing for one minute with neutral soap to remove the transient flora.
- Hand antisepsis using Propanolol-1 60% in both hands.
- Bacterial sample collection from right hand.
- Sterile surgical glove in both hands.
- Bacterial sample collection from left hand three hours later
Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.Drug
- Pre-washing for one minute with neutral soap to remove the transient flora.
- Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate.
- Bacterial sample collection from right hand.
- Sterile surgical glove in both hands.
- Bacterial sample collection from left hand three hours later.
| Study group | Role | What they receive |
|---|---|---|
| Hand antisepsis with propanolol-1 60% | Active comparator | Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control. Receives: Drug: Hand antisepsis with Propanolol- 1 60%.; Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. |
| Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate | Active comparator | Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate Receives: Drug: Hand antisepsis with Propanolol- 1 60%.; Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bacterial load immediately after hand scrub
Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure
Measured: Change from bacterial load at 5 minutes]
Secondary outcomes (1)
Reduction of bacterial load after 3 hours of hand scrub
Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
Measured: Change from bacterial load at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start10 Mar 2021 (estimated)
- Primary completion24 Mar 2021 (estimated)
- Study completion5 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntisepsisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Crossover design is used
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Ortopedico y Quirurgico del Pie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Becerro de Bengoa Vallejo, Centro Ortopedico y Quirurgico del Pie
- Investigators
- Ricardo Becerro de Bengoa Vallejo, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683146
- Sponsor's protocol ID
- RICBEC2
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A number will be assigned to each participant
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
- ClinicalTrials.gov ID
- NCT04683146
- Acronym / sponsor ID
- RICBEC2
- Conditions
- Antisepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centro Ortopedico y Quirurgico del PieUniversity, hospital or other
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 24 Mar 2021 (estimated)
- Study completion
- 5 Jun 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.
Detailed description
The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment Crossover design is used
| Arm | Type | Receives |
|---|---|---|
| Hand antisepsis with propanolol-1 60% | Active comparator | Drug: Hand antisepsis with Propanolol- 1 60%., Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control. |
| Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate | Active comparator | Drug: Hand antisepsis with Propanolol- 1 60%., Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with healthy skin in both hands and short fingernails.
- No use of antibacterial agents for at least three days before the intervention.
- Not received antibiotic treatment for at least ten days before the intervention.
Key exclusion criteria (4 listed)
- Known systemic pathologies
- Wearing hand jewelry on the hands
- Allergy to any ingredient of which the solutions used in the clinical trial are composed
- Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing
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 |
|---|---|---|
| Hand antisepsis with Propanolol- 1 60%.* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using Propanolol-1 60% in both hands. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later | Drug | Hand antisepsis with propanolol-1 60%, Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate |
| Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later. | Drug | Hand antisepsis with propanolol-1 60%, Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate |
Primary outcome
Reduction of bacterial load immediately after hand scrub
Time frame: Change from bacterial load at 5 minutes]
Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure
1 secondary outcome
Reduction of bacterial load after 3 hours of hand scrub
Time frame: Change from bacterial load at 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No. A number will be assigned to each participant
Related trials for Antisepsis
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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.
Ricardo Becerro de Bengoa Vallejo principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hand antisepsis with Propanolol- 1 60%. and Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. in people with Antisepsis, run by Centro Ortopedico y Quirurgico del Pie.
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 3 inclusion and 4 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Ricardo Becerro de Bengoa Vallejo (+34 670678145, ribebeva@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bacterial load immediately after hand scrub (time frame: Change from bacterial load at 5 minutes]). 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 24 Dec 2020.