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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04454619
Acronym
sorbectol
Enrollment
24
Registered
2020-07-01
Start date
2020-07-12
Completion date
2020-08-15
Last updated
2020-08-31

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 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.

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 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.

Interventions

DRUGHand antisepsis with Clorhexidine and solution

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

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 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

Design outcomes

Primary

MeasureTime frameDescription
Change of bacterial load measured in CFU immediately after hand scrubChange from bacterial load at 5 minutesParticipants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure

Secondary

MeasureTime frameDescription
Change of bacterial loadmeaured in CFU 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

Countries

Spain

Outcome results

None listed

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