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

NCT04683146 | Unknown Phase 4

• 1 other identifier: RICBEC2
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antisepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of bacterial load after 3 hours of hand scrub

  Change from bacterial load at 3 hours

Study Arms (2)

Hand antisepsis with propanolol-1 60%

ACTIVE COMPARATOR

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

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

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

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

Interventions

Hand antisepsis with Propanolol- 1 60%. DRUG

* 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 propanolol-1 60%; Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

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

* 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.

Hand antisepsis with propanolol-1 60%; Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Ortopedico y Quirurgico del Pie: lead

MeSH Terms

Interventions

Ethanol; chlorhexidine gluconate; Sorbic Acid

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Ricardo Becerro de Bengoa Vallejo

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Becerro de Bengoa Vallejo

CONTACT

+34 670678145; ribebeva@ucm.es

Marta E Losa Iglesias

CONTACT

+34 616962413; marta.losa@urjc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The samples will be sent to the laboratory with numbers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Crossover Assignment Crossover design is used

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: March 10, 2021
• Primary Completion: March 24, 2021
• Study Completion: June 5, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share