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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ricardo Becerro de Bengoa Vallejo; Phone Number: +34 670678145; Email: ribebeva@ucm.es
• Study Contact Backup: Name: Marta E Losa Iglesias; Phone Number: +34 616962413; Email: marta.losa@urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hand antisepsis with propanolol-1 60%; Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control.	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; Drug: 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.
Active Comparator: Hand antisepsis with 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	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; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centro Ortopedico y Quirurgico del Pie
• Investigators: Principal Investigator: Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Anticipated): March 10, 2021
• Primary Completion (Anticipated): March 24, 2021
• Study Completion (Anticipated): June 5, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Propranolol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: RICBEC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A number will be assigned to each participant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No