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

Antisepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04683146
• Other study ID #: RICBEC2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 10, 2021
• Est. completion date: June 5, 2021

Study information

• Verified date: December 2020
• Source: Centro Ortopedico y Quirurgico del Pie
• Contact: Ricardo Becerro de Bengoa Vallejo
• Phone: +34 670678145
• Email: ribebeva[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 5, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Antisepsis

Intervention

Drug:
• Hand 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
• Hand 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Ortopedico y Quirurgico del Pie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of bacterial load immediately after hand scrub	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure	Change from bacterial load at 5 minutes]
Secondary	Reduction of bacterial load after 3 hours of hand scrub	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours	Change from bacterial load at 3 hours