Hand WashingNCT06688890
Optimization of Surgical Hand Preparation Using Sorbectol
A study testing Surgical hand rub with the reference product; n-propanol 60%., Surgical hand rub with the product P1; Sorbectol for 1 min. and Surgical hand rub with the product P2; Sorbectol for 3 min. in people with Hand Washing, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Previous studies evaluated the efficacy of the hydroalcoholic solution of 3% digluconate of chlorhexidine, 0.3% potassium sorbate and 70% ethanol, "Sorbectol" (Spanish patent ES 2 784 275 B2) in the surgical hand preparation with positive results. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Washing
- What is being tested?
- Surgical hand rub with the reference product; n-propanol 60%., Surgical hand rub with the product P1; Sorbectol for 1 min. and Surgical hand rub with the product P2; Sorbectol for 3 min.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2023to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, 28040
María del Mar Parra, +34916500390, mariadelmar.parra@ucm.es
About this study
Official title: Optimization of the Effectiveness of the Hydroalcoholic Solution of 3% Chlorhexidine Digluconate and 0.3% Potassium Sorbate in 70% Ethanol, Sorbectol, in Surgical Hand Preparation According to the UNE-EN 12791 Standard
Previous studies evaluated the efficacy of the hydroalcoholic solution of 3% digluconate of chlorhexidine, 0.3% potassium sorbate and 70% ethanol, "Sorbectol" (Spanish patent ES 2 784 275 B2) in the surgical hand preparation with positive results. This clinical trial is focused on optimising the effectiveness of Sorbectol in the surgical hand preparation by scaling the application times of the product from 1 to 5 minutes following the test procedure and the effectiveness criteria of the European norm EN-12791.
Read the detailed description
This is a randomised clinical trial with a Latin-square crossover design, to test the effectiveness of the Sorbectol solution in surgical hand preparation, according to the EN 12791 standard, at application times of 1, 3 or 5 minutes. The test compares the bacterial load on the hands of at least 23 healthy volunteers immediately (immediate effect) and three hours after (3-hour effect) application of the test product with respect to the reference product, RP, of EN 12791 (n-propanol 60%).
Briefly: The bacterial load on hands before antisepsis (pre-values) is obtained after the preparatory handwash using a diluted soft soap. Next, surgical hand antisepsis protocols are performed. Enrolled participants are randomly divided into four groups of the same size to receive RP or Sorbectol for 1 min (P1), 3 min (P2) or 5 min (P3) in parallel in a first run. The test is repeated in a second, third and fourth run changing the antisepsis roles for each group. A washout period of at least 2 weeks between experimental runs allow for the reconstitution of skin microbiota. All participants complete the four antiseptic procedures at the end of the trial.
The RP group, rub their hands with n-propanol (60% v/v) for 3 min. The test product groups, rub their hands with Sorbectol for 1 or 3 or 5 min. In all cases applying as many 3 ml portions as necessary to keep the hands moist for the selected time. After antisepsis the bacterial load (post-values) is determined using a split-hands model. One hand to assess the bacterial load immediately after treatment (immediate post-values) and the other hand to assess the bacterial load 3 hours later, keeping the hand gloved in the meantime (3-h post-values).
- Conditions
- Hand Washing
- Being tested
- Surgical hand rub with the reference product; n-propanol 60%., Surgical hand rub with the product P1; Sorbectol for 1 min., Surgical hand rub with the product P2; Sorbectol for 3 min., Surgical hand rub with the product P3; Sorbectol for 5 min.
- Keywords
- Sorbectol, bacterial load, inmediate effect, prolongated effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical hand rub with the reference product; n-propanol 60%.Other
Propanol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.
Surgical hand rub with the product P1; Sorbectol for 1 min.Other
Sorbectol hand rub for 1 min. The applied volume of product is sufficient to keep the hand moist for a total time of 1 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.
Surgical hand rub with the product P2; Sorbectol for 3 min.Other
Sorbectol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.
Surgical hand rub with the product P3; Sorbectol for 5 min.Other
Sorbectol hand rub for 5 min. The applied volume of product is sufficient to keep the hand moist for a total time of 5 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.
| Study group | Role | What they receive |
|---|---|---|
| 1. Surgical hand rub with the reference product; n-propanol 60%. | Experimental | Not described Receives: Other: Surgical hand rub with the reference product; n-propanol 60%. |
| 2. Surgical hand rub with the product P1; Sorbectol for 1 min. | Experimental | Not described Receives: Other: Surgical hand rub with the product P1; Sorbectol for 1 min. |
| 3. Surgical hand rub with the product P2;Sorbectol for 3 min. | Experimental | Not described Receives: Other: Surgical hand rub with the product P2; Sorbectol for 3 min. |
| 4. Surgical hand rub with the product P3; Sorbectol for 5 min. | Experimental | Not described Receives: Other: Surgical hand rub with the product P3; Sorbectol for 5 min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate effect assessed immediately after surgical hand antisepsis
It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved immediately after the application of surgical hand antisepsis in one of the hands.
The immediate effect is calculated by using the expression Log CFU/ml of immediate pre-values minus Log CFU/ml of immediate post-values, where the immediate pre-values are the bacterial counts pre-existing on the selected hand for immediate effect before disinfection, at the time point 0, and the immediate post-values are the bacterial counts determined on the same hand after the application of the antiseptic, at the time point 1.This primary outcome measure is used to evaluate the non-inferiority criterium proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.
Measured: Immediate effect is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]
Effect assessed 3-hours after surgical hand antisepsis
It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved 3 hours after of the surgical hand antisepsis on the opposite hand used for immediate effect determination.
The 3-hours effect is calculated by using the expression Log CFU/ml of 3-hours pre-values minus Log CFU/ml of 3-hours post-values, where the 3-hours pre-values are the bacterial count pre-existing on the selected hand for 3-hours effect determination before disinfection, at the time point 0, and the 3-hours post-values are the bacterial count determined on the same hand 3-hours after the application of the antiseptic, at the time point 2.This primary outcome measure is used to evaluate the non-inferiority and sustained effect criteria proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.
Measured: The 3-hours effect is a measure determined at the time point 2 which is 3 hours after the immediate effect determination]
Secondary outcomes (3)
Bacterial counts preexisting on the hands before surgical hand antisepsis. Pre-values.
This refers to the bacterial counts (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) preexisting on the hands before surgical hand antisepsis. Preexisting bacterial counts are determined on each hand, in parallel at the time point 0. The bacterial count determined on one hand is called the immediate pre-value, and the bacterial count determined on the other hand is called the 3-hour pre-value This secondary outcome measure is used to calculate the extension of the immediate and 3-hours effect primary outcome measures for tested antiseptic protocols, P1, P2, P3 and the RP.
Measured: Prevalues is a measure determined at the time point 0 which represent the beginning of the disinfection assay
Bacterial counts immediately after surgical hand antisepsis. Immediate post-values
It refers to the bacterial count (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) determined immediately after surgical hand antisepsis. This bacterial count, called the immediate post-value, is determined on the selected hand for immediate effect, at time point 1.
This secondary outcome measure is used to calculate the extension of the immediate effect primary outcome measure for tested antiseptic protocols, P1, P2, P3 and the RP.
Measured: Immediate post-value is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]
Bacterial counts 3-hours after surgical hand antisepsis. 3-hours post-values
This refers to the bacterial count (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) determined 3-hours after surgical hand antisepsis. This bacterial count, called the 3-hours post-value, is determined on the selected hand for 3-hours effect, at time point 2.
This secondary outcome measure is used to calculate the extension of the 3-hours effect primary outcome measure for tested antiseptic protocols, P1, P2, P3 and the RP.
Measured: 3-hours post-value is a measure determined at the time point 2, which is 3 hours after the immediate post-value determination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start12 Jul 2023
- Primary completion18 Dec 2024 (estimated)
- Study completion18 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand WashingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- clinical trial, randomized, crossover.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA DEL MAR PARRA RODRIGUEZ, Universidad Complutense de Madrid
- Investigators
- PARRA, Principal investigator, UNIVERSIDAD COMPLUTENSE MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688890
- Sponsor's protocol ID
- SORBUCM_MP
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rutala WA, Boyce JM, Weber DJ. Disinfection, sterilization and antisepsis: An overview. Am J Infect Control. 2023 Nov;51(11S):A3-A12. doi: 10.1016/j.ajic.2023.01.001.
PubMed 37890951Herraiz Soria E, Alou L, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias M, Sevillano D. Alcohol-Based Chlorhexidine and Potassium Sorbate Rub Strengthens the Effectiveness of Traditional Hand Scrubbing and Improves Long-Lasting Effectiveness-Evaluation of Hand Preparation Protocols According to EN 12791. Antibiotics (Basel). 2024 May 20;13(5):470. doi: 10.3390/antibiotics13050470.
PubMed 38786198
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Effectiveness of the Hydroalcoholic Solution of 3% Chlorhexidine Digluconate and 0.3% Potassium Sorbate in 70% Ethanol, Sorbectol, in Surgical Hand Preparation According to the UNE-EN 12791 Standard
- ClinicalTrials.gov ID
- NCT06688890
- Acronym / sponsor ID
- SORBUCM_MP
- Conditions
- Hand Washing
- Keywords
- Sorbectol, bacterial load, inmediate effect, prolongated effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 18 Dec 2024 (estimated)
- Study completion
- 18 Dec 2024 (estimated)
- First posted
- 14 Nov 2024 (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.
Previous studies evaluated the efficacy of the hydroalcoholic solution of 3% digluconate of chlorhexidine, 0.3% potassium sorbate and 70% ethanol, "Sorbectol" (Spanish patent ES 2 784 275 B2) in the surgical hand preparation with positive results. This clinical trial is focused on optimising the effectiveness of Sorbectol in the surgical hand preparation by scaling the application times of the product from 1 to 5 minutes following the test procedure and the effectiveness criteria of the European norm EN-12791.
Detailed description
This is a randomised clinical trial with a Latin-square crossover design, to test the effectiveness of the Sorbectol solution in surgical hand preparation, according to the EN 12791 standard, at application times of 1, 3 or 5 minutes. The test compares the bacterial load on the hands of at least 23 healthy volunteers immediately (immediate effect) and three hours after (3-hour effect) application of the test product with respect to the reference product, RP, of EN 12791 (n-propanol 60%).
Briefly: The bacterial load on hands before antisepsis (pre-values) is obtained after the preparatory handwash using a diluted soft soap. Next, surgical hand antisepsis protocols are performed. Enrolled participants are randomly divided into four groups of the same size to receive RP or Sorbectol for 1 min (P1), 3 min (P2) or 5 min (P3) in parallel in a first run. The test is repeated in a second, third and fourth run changing the antisepsis roles for each group. A washout period of at least 2 weeks between experimental runs allow for the reconstitution of skin microbiota. All participants complete the four antiseptic procedures at the end of the trial.
The RP group, rub their hands with n-propanol (60% v/v) for 3 min. The test product groups, rub their hands with Sorbectol for 1 or 3 or 5 min. In all cases applying as many 3 ml portions as necessary to keep the hands moist for the selected time. After antisepsis the bacterial load (post-values) is determined using a split-hands model. One hand to assess the bacterial load immediately after treatment (immediate post-values) and the other hand to assess the bacterial load 3 hours later, keeping the hand gloved in the meantime (3-h post-values).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- clinical trial, randomized, crossover.
| Arm | Type | Receives |
|---|---|---|
| 1. Surgical hand rub with the reference product; n-propanol 60%. | Experimental | Other: Surgical hand rub with the reference product; n-propanol 60%. |
| 2. Surgical hand rub with the product P1; Sorbectol for 1 min. | Experimental | Other: Surgical hand rub with the product P1; Sorbectol for 1 min. |
| 3. Surgical hand rub with the product P2;Sorbectol for 3 min. | Experimental | Other: Surgical hand rub with the product P2; Sorbectol for 3 min. |
| 4. Surgical hand rub with the product P3; Sorbectol for 5 min. | Experimental | Other: Surgical hand rub with the product P3; Sorbectol for 5 min. |
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 |
|---|---|---|
| Surgical hand rub with the reference product; n-propanol 60%.Propanol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs. | Other | 1. Surgical hand rub with the reference product; n-propanol 60%. |
| Surgical hand rub with the product P1; Sorbectol for 1 min.Sorbectol hand rub for 1 min. The applied volume of product is sufficient to keep the hand moist for a total time of 1 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs. | Other | 2. Surgical hand rub with the product P1; Sorbectol for 1 min. |
| Surgical hand rub with the product P2; Sorbectol for 3 min.Sorbectol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs. | Other | 3. Surgical hand rub with the product P2;Sorbectol for 3 min. |
| Surgical hand rub with the product P3; Sorbectol for 5 min.Sorbectol hand rub for 5 min. The applied volume of product is sufficient to keep the hand moist for a total time of 5 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs. | Other | 4. Surgical hand rub with the product P3; Sorbectol for 5 min. |
Primary outcome
Immediate effect assessed immediately after surgical hand antisepsis
Time frame: Immediate effect is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]
It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved immediately after the application of surgical hand antisepsis in one of the hands. The immediate effect is calculated by using the expression Log CFU/ml of immediate pre-values minus Log CFU/ml of immediate post-values, where the immediate pre-values are the bacterial counts pre-existing on the selected hand for immediate effect before disinfection, at the time point 0, and the immediate post-values are the bacterial counts determined on the same hand after the application of the antiseptic, at the time point 1.This primary outcome measure is used to evaluate the non-inferiority criterium proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.
Effect assessed 3-hours after surgical hand antisepsis
Time frame: The 3-hours effect is a measure determined at the time point 2 which is 3 hours after the immediate effect determination]
It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved 3 hours after of the surgical hand antisepsis on the opposite hand used for immediate effect determination. The 3-hours effect is calculated by using the expression Log CFU/ml of 3-hours pre-values minus Log CFU/ml of 3-hours post-values, where the 3-hours pre-values are the bacterial count pre-existing on the selected hand for 3-hours effect determination before disinfection, at the time point 0, and the 3-hours post-values are the bacterial count determined on the same hand 3-hours after the application of the antiseptic, at the time point 2.This primary outcome measure is used to evaluate the non-inferiority and sustained effect criteria proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.
3 secondary outcomes
Bacterial counts preexisting on the hands before surgical hand antisepsis. Pre-values.
Time frame: Prevalues is a measure determined at the time point 0 which represent the beginning of the disinfection assay
Bacterial counts immediately after surgical hand antisepsis. Immediate post-values
Time frame: Immediate post-value is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]
Bacterial counts 3-hours after surgical hand antisepsis. 3-hours post-values
Time frame: 3-hours post-value is a measure determined at the time point 2, which is 3 hours after the immediate post-value determination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 37890951Rutala WA, Boyce JM, Weber DJ. Disinfection, sterilization and antisepsis: An overview. Am J Infect Control. 2023 Nov;51(11S):A3-A12. doi: 10.1016/j.ajic.2023.01.001.
- Background: PubMed 38786198Herraiz Soria E, Alou L, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias M, Sevillano D. Alcohol-Based Chlorhexidine and Potassium Sorbate Rub Strengthens the Effectiveness of Traditional Hand Scrubbing and Improves Long-Lasting Effectiveness-Evaluation of Hand Preparation Protocols According to EN 12791. Antibiotics (Basel). 2024 May 20;13(5):470. doi: 10.3390/antibiotics13050470.
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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.
PARRA principal investigator
UNIVERSIDAD COMPLUTENSE MADRID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical hand rub with the reference product; n-propanol 60%., Surgical hand rub with the product P1; Sorbectol for 1 min. and Surgical hand rub with the product P2; Sorbectol for 3 min. in people with Hand Washing, 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 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PARRA (+34916500390, mariadelmar.parra@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate effect assessed immediately after surgical hand antisepsis (time frame: Immediate effect is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]). 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?
On the ClinicalTrials.gov record for NCT06688890, which also lists 2 linked publications.
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 14 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.