AntisepsisPhase 4sorbectolNCT04454619
Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
A Phase 4 study testing Hand antisepsis with Clorhexidine and solution in people with Antisepsis, run by Centro Ortopedico y Quirurgico del Pie at 1 site in Spain.
Trial summary
The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in order to test if pass… 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 Clorhexidine and solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2020to 15 Aug 2020
- 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 without systemic pathologies, with healthy skin of the hands and short fingernails.
- They do not use substances with antibacterial action.
Who cannot join
- Taken antibiotics before 10 days of the intervention.
- Wear any jewellery on the hands
Trial locations and contacts
1 site in 1 country.
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 scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 Clorhexidine and solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand antisepsis with Clorhexidine and solutionDrug
Also called Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate
Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
| 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 propanolol-1 60% as control Receives: Drug: Hand antisepsis with Clorhexidine and solution |
| Hand antisepsis with Clorhexidina and solution | Experimental | chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. Receives: Drug: Hand antisepsis with Clorhexidine and solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bacterial load measured in CFU 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)
Change of bacterial loadmeaured in CFU 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 posted1 Jul 2020
- Study start12 Jul 2020
- Primary completion18 Jul 2020
- Study completion15 Aug 2020
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 (actual)
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
- NCT04454619
- Sponsor's protocol ID
- RICBEC
- Acronym
- sorbectol
- Status last verified
- Aug 2020
- First submitted
- 26 Jun 2020
- Last updated
- 31 Aug 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 31 Aug 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
- NCT04454619
- Acronym / sponsor ID
- sorbectol / RICBEC
- Conditions
- Antisepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centro Ortopedico y Quirurgico del PieUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 1 Jul 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 scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 Clorhexidine and solutionEffectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control |
| Hand antisepsis with Clorhexidina and solution | Experimental | Drug: Hand antisepsis with Clorhexidine and solutionchlorhexidine gluconate with the addition of an alcoholic solution of 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 (2 listed)
- Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
- They do not use substances with antibacterial action.
Key exclusion criteria (2 listed)
- Taken antibiotics before 10 days of the intervention.
- Wear any jewellery on the hands
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 Clorhexidine and solutionAlso: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbateHand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side | Drug | Hand antisepsis with Clorhexidina and solution, Hand antisepsis with propanolol-1 60% |
Primary outcome
Change of bacterial load measured in CFU 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
Change of bacterial loadmeaured in CFU after 3 hours of hand scrub
Time frame: Change from bacterial load at 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No. A number will be assigned to each participant
Related trials for Antisepsis
RecruitingPhase 4
Nasal Antisepsis for C. Auris Prevention
Candida Auris Infection, Colonization, Asymptomatic
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
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 Hand antisepsis with Clorhexidine and solution in people with Antisepsis, run by Centro Ortopedico y Quirurgico del Pie at 1 site in Spain.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 31 Aug 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bacterial load measured in CFU 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 31 Aug 2020.