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Completed

NCT Number: NCT04538365

Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facultad de Enfermeria, Fisioterapia y Podologia

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triclosan 0.5 % Topical Solution

Drug

Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side

Other names: Hand antisepsis with Triclosan 0.5% solution.

Propanolol

Drug

Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side

Other names: Hand antisepsis with Propanolol 60% solution

Primary outcomes

  1. 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

  1. Reduction of bacterial load after 3 hours of hand scrub

    Time frame: Change from bacterial load after 3 hours

    Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub after 3 hours

Sponsors and collaborators

Lead sponsor

Centro Ortopedico y Quirurgico del Pie

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2020
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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