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

Centro Ortopedico y Quirurgico del Pie

Status and phase: Completed; Phase 4

Conditions: Antisepsis

Treatments: Drug: Hand antisepsis with Clorhexidine and solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04454619

RICBEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Hand antisepsis with propanolol-1 60%

Active Comparator group

Description:

Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control

Treatment:

Drug: Hand antisepsis with Clorhexidine and solution

Hand antisepsis with Clorhexidina and solution

Experimental group

Description:

chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.

Treatment:

Drug: Hand antisepsis with Clorhexidine and solution