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

Phase 4

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

• Registration Number: NCT04683146
• Lead Sponsor: Centro Ortopedico y Quirurgico del Pie

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-20
• Last Update Submitted: 2020-12-20
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Study Start: 2021-03-10
• Primary Completion: 2021-03-24
• Study Completion: 2021-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand antisepsis with propanolol-1 60%	Hand antisepsis with Propanolol- 1 60%.	Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control.
Hand antisepsis with propanolol-1 60%	Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.	Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control.
Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate	Hand antisepsis with Propanolol- 1 60%.	Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate
Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate	Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.	Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

Primary Outcome Measures

Name	Time	Method
Reduction of bacterial load immediately after hand scrub	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 Outcome Measures

Name	Time	Method
Reduction of bacterial load after 3 hours of hand scrub	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