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Clinical Trials/NCT04683146
NCT04683146
Unknown
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 Pie0 sites24 target enrollmentMarch 10, 2021

Overview

Phase
Phase 4
Intervention
Hand antisepsis with Propanolol- 1 60%.
Conditions
Antisepsis
Sponsor
Centro Ortopedico y Quirurgico del Pie
Enrollment
24
Primary Endpoint
Reduction of bacterial load immediately after hand scrub
Last Updated
5 years ago

Overview

Brief Summary

The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, 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 surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, 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
March 10, 2021
End Date
June 5, 2021
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 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.

Exclusion Criteria

  • 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

Arms & Interventions

Hand antisepsis with propanolol-1 60%

Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control.

Intervention: Hand antisepsis with Propanolol- 1 60%.

Hand antisepsis with propanolol-1 60%

Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control.

Intervention: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

Intervention: Hand antisepsis with Propanolol- 1 60%.

Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

Intervention: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

Outcomes

Primary Outcomes

Reduction of bacterial load 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

  • Reduction of bacterial load after 3 hours of hand scrub(Change from bacterial load at 3 hours)

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