Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change of bacterial load measured in CFU immediately after hand scrub
Study Overview
Brief Summary
The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate 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 addition of a solution of chlorhexidine digluconate and potassium sorbate 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The samples will be sent to the laboratory with numbers
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Hand antisepsis with propanolol-1 60%
Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control
Intervention: Hand antisepsis with Clorhexidine and solution (Drug)
Hand antisepsis with Clorhexidina and solution
chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.
Intervention: Hand antisepsis with Clorhexidine and solution (Drug)
Outcomes
Primary Outcomes
Change of bacterial load measured in CFU immediately after hand scrub
Time Frame: Change from bacterial load at 5 minutes
Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure
Secondary Outcomes
- Change of bacterial loadmeaured in CFU after 3 hours of hand scrub(Change from bacterial load at 3 hours)
Investigators
Ricardo Becerro de Bengoa Vallejo
Principal Investigator
Centro Ortopedico y Quirurgico del Pie