Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
June 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedJuly 21, 2020
July 1, 2020
20 days
June 22, 2020
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from bacterial load at 5 minutes.
Secondary Outcomes (1)
Reduction of bacterial load after 3 hours of hand scrub
Change from bacterial load at 3 hours.
Study Arms (2)
Hand antisepsis by scrub
EXPERIMENTALHand antisepsis by scrub using propan-ol-1 60%
Hand antisepsis by rub
ACTIVE COMPARATORHand antisepsis by rub using propan-ol-1 60%
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
- They do not use substances with antibacterial action.
You may not qualify if:
- Taken antibiotics before 10 days of the intervention.
- Wear any jewellery on the hands.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ricardo Becerro de Bengoa Vallejo
Madrid, 28040, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Becerro de Bengoa Vallejo, PhD
Ricardo becerro de Bengoa Vallejo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The samples will be sent to the laboratory with numbers.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 25, 2020
Study Start
June 28, 2020
Primary Completion
July 18, 2020
Study Completion
July 20, 2020
Last Updated
July 21, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
A number will be assigned to each participant