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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04683146
Enrollment
24
Registered
2020-12-24
Start date
2021-03-10
Completion date
2021-06-05
Last updated
2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antisepsis

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.

Interventions

DRUGHand antisepsis with Propanolol- 1 60%.

* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using Propanolol-1 60% in both hands. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later

DRUGHand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later.

Sponsors

Centro Ortopedico y Quirurgico del Pie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The samples will be sent to the laboratory with numbers

Intervention model description

Crossover Assignment Crossover design is used

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of bacterial load immediately after hand scrubChange 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

MeasureTime frameDescription
Reduction of bacterial load after 3 hours of hand scrubChange from bacterial load at 3 hoursParticipants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours

Contacts

Primary ContactRicardo Becerro de Bengoa Vallejo
ribebeva@ucm.es+34 670678145
Backup ContactMarta E Losa Iglesias
marta.losa@urjc.es+34 616962413

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026