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Clinical Trials/NCT04538365
NCT04538365
Completed
Phase 4

Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant

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

Overview

Phase
Phase 4
Intervention
propanolol
Conditions
Antisepsis
Sponsor
Centro Ortopedico y Quirurgico del Pie
Enrollment
24
Locations
1
Primary Endpoint
Reduction of bacterial load 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 propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% 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 trocilosan 0.5% 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
October 1, 2020
End Date
October 30, 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: propanolol

Hand antisepsis with triclosan solution

Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution

Intervention: Triclosan 0.5 % Topical Solution

Outcomes

Primary Outcomes

Reduction of bacterial load immediately after hand scrub

Time Frame: Change from bacterial load at 5 minutes

Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub procedure

Secondary Outcomes

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

Study Sites (1)

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