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Clinical Trials/NCT04454619
NCT04454619
Completed
Phase 4

Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

Centro Ortopedico y Quirurgico del Pie1 site in 1 country24 target enrollmentJuly 12, 2020

Overview

Phase
Phase 4
Intervention
Hand antisepsis with Clorhexidine and solution
Conditions
Antisepsis
Sponsor
Centro Ortopedico y Quirurgico del Pie
Enrollment
24
Locations
1
Primary Endpoint
Change of bacterial load measured in CFU immediately after hand scrub
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2020
End Date
August 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Centro Ortopedico y Quirurgico del Pie
Responsible Party
Principal Investigator
Principal Investigator

Ricardo Becerro de Bengoa Vallejo

Principal Investigator

Centro Ortopedico y Quirurgico del Pie

Eligibility Criteria

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

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

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)

Study Sites (1)

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