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

Sponsor

Centro Ortopedico y Quirurgico del Pie (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04683146

Collaborator

(none)

Enrollment

Arms

2.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antisepsis	Drug: Hand antisepsis with Propanolol- 1 60%. Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Crossover Assignment Crossover design is usedCrossover Assignment Crossover design is used

Masking:

Single (Outcomes Assessor)

Masking Description:

The samples will be sent to the laboratory with numbers

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 10, 2021

Anticipated Primary Completion Date :

Mar 24, 2021

Anticipated Study Completion Date :

Jun 5, 2021

Arms and Interventions

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.

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%.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro Ortopedico y Quirurgico del Pie

Investigators

Principal Investigator: Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo Becerro de Bengoa Vallejo, Principal investigator, Centro Ortopedico y Quirurgico del Pie

ClinicalTrials.gov Identifier:

NCT04683146

Other Study ID Numbers:

RICBEC2

First Posted:

Dec 24, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chlorhexidine

Chlorhexidine gluconate

Propranolol

Study Results

No Results Posted as of Dec 24, 2020