Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
Overview
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.
Full Title of Study: “Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: July 18, 2020
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.
Interventions
- Drug: Hand antisepsis by scrub
- 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.
- Drug: Hand antisepsis by scrub
- 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.
Arms, Groups and Cohorts
- Experimental: Hand antisepsis by scrub
- Hand antisepsis by scrub using propan-ol-1 60%
- Active Comparator: Hand antisepsis by rub
- Hand antisepsis by rub using propan-ol-1 60%
Clinical Trial Outcome Measures
Primary Measures
- 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.
Secondary Measures
- Reduction of bacterial load after 3 hours of hand scrub
- Time Frame: Change from bacterial load at 3 hours.
- Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
Participating in This Clinical Trial
Inclusion Criteria
- Participants without systemic pathologies, with healthy skin of the hands and short fingernails. – They do not use substances with antibacterial action. Exclusion Criteria:
- Taken antibiotics before 10 days of the intervention. – Wear any jewellery on the hands.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Universidad Complutense de Madrid
- Provider of Information About this Clinical Study
- Principal Investigator: César Calvo Lobo, Principal Investigator – Universidad Complutense de Madrid
- Overall Official(s)
- Ricardo Becerro de Bengoa Vallejo, PhD, Principal Investigator, Ricardo becerro de Bengoa Vallejo
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