AntisepsisPhase 4NCT04538365
Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%
A Phase 4 study testing Triclosan 0.5 % Topical Solution and propanolol 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 propanol- 1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% in order to test if pass the standard european norm 12791. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Antisepsis
- What is being tested?
- Triclosan 0.5 % Topical Solution and propanolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 30 Oct 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 60 years
- All sexes
- Healthy volunteers accepted
- 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: Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant
The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propanol-
1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% 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 trocilosan 0.5% 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
- Triclosan 0.5 % Topical Solution, propanolol
- Keywords
- hand washing, presurgical antisepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan 0.5 % Topical SolutionDrug
Also called Hand antisepsis with Triclosan 0.5% solution.
Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
propanololDrug
Also called Hand antisepsis with Propanolol 60% solution
Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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: propanolol |
| Hand antisepsis with triclosan solution | Experimental | Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution Receives: Drug: Triclosan 0.5 % Topical Solution |
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 with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub 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 with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub after 3 hours
Measured: Change from bacterial load after 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Oct 2020
- Primary completion20 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 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 B Becerro de Bengoa Vallejo, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538365
- Sponsor's protocol ID
- RICBEC1
- Status last verified
- Oct 2020
- First submitted
- 29 Aug 2020
- Last updated
- 2 Nov 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
Publications
Sante L, Gomez-Lus ML, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Alou L, Sevillano D. Effect on the reduction of bacterial load after surgical hand antisepsis with triclosan 0.5% compared to triclosan 0.5% followed by 70% alcoholic solution. Infect Control Hosp Epidemiol. 2023 Mar;44(3):517-519. doi: 10.1017/ice.2021.506. Epub 2021 Dec 22.
PubMed 34933701
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant
- ClinicalTrials.gov ID
- NCT04538365
- Acronym / sponsor ID
- RICBEC1
- Conditions
- Antisepsis
- Keywords
- hand washing, presurgical 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
- 1 Oct 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 4 Sep 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 propanol-
1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% 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 trocilosan 0.5% 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 design is used
| Arm | Type | Receives |
|---|---|---|
| Hand antisepsis with propanolol-1 60% | Active comparator | Drug: propanololEffectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control |
| Hand antisepsis with triclosan solution | Experimental | Drug: Triclosan 0.5 % Topical SolutionEffectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| Triclosan 0.5 % Topical SolutionAlso: Hand antisepsis with Triclosan 0.5% solution.Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution 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 triclosan solution |
| propanololAlso: Hand antisepsis with Propanolol 60% solutionHand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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 propanolol-1 60% |
Primary outcome
Reduction of bacterial load immediately after hand scrub
Time frame: Change from bacterial load at 5 minutes
Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub procedure
1 secondary outcome
Reduction of bacterial load after 3 hours of hand scrub
Time frame: Change from bacterial load after 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 2 Nov 2020.
- Derived from this study: PubMed 34933701Sante L, Gomez-Lus ML, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Alou L, Sevillano D. Effect on the reduction of bacterial load after surgical hand antisepsis with triclosan 0.5% compared to triclosan 0.5% followed by 70% alcoholic solution. Infect Control Hosp Epidemiol. 2023 Mar;44(3):517-519. doi: 10.1017/ice.2021.506. Epub 2021 Dec 22.
- Individual participant dataSharing planned: No. A number will be assigned to each participant
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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 B Becerro de Bengoa Vallejo, PhD 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 Triclosan 0.5 % Topical Solution and propanolol 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 2 Nov 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?
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?
On the ClinicalTrials.gov record for NCT04538365, which also lists 1 linked publication.
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 2 Nov 2020.