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

Centro Ortopedico y Quirurgico del Pie

Status and phase: Unknown; Phase 4

Conditions: Antisepsis

Treatments: Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.; Drug: Hand antisepsis with Propanolol- 1 60%.

Study type: Interventional

Funder types: Other

Identifiers

NCT04683146

RICBEC2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

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 propranolol- 1 60% as control.

Treatment:

Drug: Hand antisepsis with Propanolol- 1 60%.

Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Active Comparator group

Description:

Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

Treatment:

Drug: Hand antisepsis with Propanolol- 1 60%.

Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.