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

NCT ID: NCT04683146

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-06-05

Brief Summary

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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

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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.

Conditions

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Antisepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment Crossover design is used
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The samples will be sent to the laboratory with numbers

Study Groups

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Hand antisepsis with propanolol-1 60%

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

Group Type ACTIVE_COMPARATOR

Hand antisepsis with Propanolol- 1 60%.

Intervention Type 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 a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Hand antisepsis with Propanolol- 1 60%.

Intervention Type 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 a solution of alcohol, chlorhexidine digluconate and potassium sorbate.

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Ortopedico y Quirurgico del Pie

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Becerro de Bengoa Vallejo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Becerro de Bengoa Vallejo

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Central Contacts

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Ricardo Becerro de Bengoa Vallejo

Role: CONTACT

Phone: +34 670678145

Email: [email protected]

Marta E Losa Iglesias

Role: CONTACT

Phone: +34 616962413

Email: [email protected]

Other Identifiers

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RICBEC2

Identifier Type: -

Identifier Source: org_study_id