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Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%

NCT ID: NCT04538365

Last Updated: 2020-11-02

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

2020-10-01

Study Completion Date

2020-10-30

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 propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% 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 trocilosan 0.5% 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 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

propanolol

Intervention Type DRUG

Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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 triclosan solution

Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution

Group Type EXPERIMENTAL

Triclosan 0.5 % Topical Solution

Intervention Type DRUG

Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution 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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Triclosan 0.5 % Topical Solution

Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution 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

propanolol

Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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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Hand antisepsis with Triclosan 0.5% solution. Hand antisepsis with Propanolol 60% solution

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

60 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 B Becerro de Bengoa Vallejo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Facultad de Enfermeria, Fisioterapia y Podologia

Madrid, , Spain

Site Status

Countries

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Spain

References

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Sante L, Gomez-Lus ML, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Alou L, Sevillano D. Effect on the reduction of bacterial load after surgical hand antisepsis with triclosan 0.5% compared to triclosan 0.5% followed by 70% alcoholic solution. Infect Control Hosp Epidemiol. 2023 Mar;44(3):517-519. doi: 10.1017/ice.2021.506. Epub 2021 Dec 22.

Reference Type DERIVED
PMID: 34933701 (View on PubMed)

Other Identifiers

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RICBEC1

Identifier Type: -

Identifier Source: org_study_id