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

NCT ID: NCT04454619

Last Updated: 2020-08-31

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-12

Study Completion Date

2020-08-15

Brief Summary

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The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 propanolol-1 60% as control

Group Type ACTIVE_COMPARATOR

Hand antisepsis with Clorhexidine and solution

Intervention Type DRUG

Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side

Hand antisepsis with Clorhexidina and solution

chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.

Group Type EXPERIMENTAL

Hand antisepsis with Clorhexidine and solution

Intervention Type DRUG

Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side

Interventions

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Hand antisepsis with Clorhexidine and solution

Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side

Intervention Type DRUG

Other Intervention Names

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Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

Eligibility Criteria

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Inclusion Criteria

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands
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

Locations

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Centro ortopedico y quirurgico del pie

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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RICBEC

Identifier Type: -

Identifier Source: org_study_id