Skin DiseasesPhase 4NCT04446923
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
A Phase 4 study testing Hand antisepsis by scrub in people with Skin Diseases and Surgical Site Infection, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Surgical Site Infection
- What is being tested?
- Hand antisepsis by scrub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jun 2020to 20 Jul 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: Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791
The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method 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 rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
- Conditions
- Skin Diseases, Surgical Site Infection
- Being tested
- Hand antisepsis by scrub
- Keywords
- hand antisepsis
- Medical subject headings
- Skin Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand antisepsis by scrubDrug
Also called Propanolol
Surgical Hand scrubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
Hand antisepsis by scrubDrug
Also called Propanolol
Surgical Hand rubbing using P-1 of 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 by scrub | Experimental | Hand antisepsis by scrub using propan-ol-1 60% Receives: Drug: Hand antisepsis by scrub |
| Hand antisepsis by rub | Active comparator | Hand antisepsis by rub using propan-ol-1 60% Receives: Drug: Hand antisepsis by scrub |
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 liquid 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 liquid 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 posted25 Jun 2020
- Study start28 Jun 2020
- Primary completion18 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
- Investigators
- Ricardo Becerro de Bengoa Vallejo, PhD, Principal investigator, Ricardo becerro de Bengoa Vallejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446923
- Sponsor's protocol ID
- RICBEC1-UCM
- Status last verified
- Jul 2020
- First submitted
- 22 Jun 2020
- Last updated
- 21 Jul 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791
- ClinicalTrials.gov ID
- NCT04446923
- Acronym / sponsor ID
- RICBEC1-UCM
- Conditions
- Skin Diseases, Surgical Site Infection
- Keywords
- hand antisepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 25 Jun 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 to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method 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 rub and scrub. 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 by scrub | Experimental | Drug: Hand antisepsis by scrubHand antisepsis by scrub using propan-ol-1 60% |
| Hand antisepsis by rub | Active comparator | Drug: Hand antisepsis by scrubHand antisepsis by rub using propan-ol-1 60% |
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 by scrubAlso: PropanololSurgical Hand scrubbing using P-1 of 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 by scrub |
| Hand antisepsis by scrubAlso: PropanololSurgical Hand rubbing using P-1 of 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 by rub |
Primary outcome
Reduction of bacterial load immediately after hand scrub
Time frame: Change from bacterial load at 5 minutes.
Participants will scrub the liquid 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
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 21 Jul 2020.
- 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 Becerro de Bengoa Vallejo, PhD principal investigator
Ricardo becerro de Bengoa Vallejo
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 by scrub in people with Skin Diseases and Surgical Site Infection, run by Universidad Complutense de Madrid 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 21 Jul 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?
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 21 Jul 2020.