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NCT Number: NCT04454619

Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

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.

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Key information

Conditions

Antisepsis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro ortopedico y quirurgico del pie

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 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.

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

Hand antisepsis with Clorhexidine and solution

Drug

Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. 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: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

Primary outcomes

  1. 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

  1. Change of bacterial loadmeaured in CFU after 3 hours of hand scrub

    Time frame: Change from bacterial load at 3 hours

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

Sponsors and collaborators

Lead sponsor

Centro Ortopedico y Quirurgico del Pie

Other

Registry information

Official study title

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

Acronym: sorbectol

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Aug 31, 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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