Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing

NCT ID: NCT04446923

Last Updated: 2020-07-21

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

2020-06-28

Study Completion Date

2020-07-20

Brief Summary

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The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method 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 rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Conditions

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Skin Diseases Surgical Site Infection

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 by scrub

Hand antisepsis by scrub using propan-ol-1 60%

Group Type EXPERIMENTAL

Hand antisepsis by scrub

Intervention Type DRUG

Surgical Hand scrubbing using P-1 of 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 by rub

Hand antisepsis by rub using propan-ol-1 60%

Group Type ACTIVE_COMPARATOR

Hand antisepsis by scrub

Intervention Type DRUG

Surgical Hand rubbing using P-1 of 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 by scrub

Surgical Hand scrubbing using P-1 of 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

Hand antisepsis by scrub

Surgical Hand rubbing using P-1 of 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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Propanolol Propanolol

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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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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César Calvo Lobo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Becerro de Bengoa Vallejo, PhD

Role: PRINCIPAL_INVESTIGATOR

Ricardo becerro de Bengoa Vallejo

Locations

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Ricardo Becerro de Bengoa Vallejo

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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RICBEC1-UCM

Identifier Type: -

Identifier Source: org_study_id

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