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A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo

NCT ID: NCT02096094

Last Updated: 2015-12-02

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-01-31

Brief Summary

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Traditional bed bathing have been related to cross-infection. In order to avoid this complication, single-use products such as wipes impregnated with chlorhexidine use is increasing. Nevertheless among nursery staff concern about its side effects prevents its widespread use. The investigators want to know if there are any differences between the use of 2% chlorhexidine wipes and a placebo concerning side effects.

Detailed Description

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Hygiene is part of health recovery in patients, nevertheless in unconscious or sedated patients this procedure becomes a task for the nursing staff. Traditional soap and water bed bath is becoming obsolete as soap could induce skin injuries due to changes in the pH of the skin and furthermore, almost every items used for this procedure could be a reservoir for pathogens, and therefore could lead to infection. Nowadays single-use products are a new option for prevent cross-infections. Nevertheless, traditional bed bathing is a tightly established practice among nursing staff. New evidence about side effects and comfort by wipe bed bathing is needed.

Chlorhexidine impregnated wipes have been used to perform the bed bathing in severe ill patients, as it can protect them from infections. The aim of this study is to determinate if bed bathing with 2% chlorhexidine impregnated wipes has a similar effect that a placebo.

Conditions

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Bed Bathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chlorhexidine bath

This arm is composed with 27 healthy volunteers which will perform full body bath with wipes impregnated with 2% chlorhexidine and with shampoo with 0.15% chlorhexidine.

Group Type EXPERIMENTAL

Standardization phase

Intervention Type PROCEDURE

Prior the principal intervention, each volunteer should complete a standardization phase, which consists in the daily bathing for two weeks with a antiseptic free soap and shampoo. Likewise would avoid chemical showers such as swimming. At the end of this phase a quantification of skin flora will be perform.

Bath with chlorhexidine

Intervention Type PROCEDURE

Volunteers will be asked to perform full body bath with wipes with 2% chlorhexidine impregnation and with 0.15% chlorhexidine shampoo (for the head and genitalia) for 3 to 5 days. Each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.

Control bath

This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine.

Group Type PLACEBO_COMPARATOR

Standardization phase

Intervention Type PROCEDURE

Prior the principal intervention, each volunteer should complete a standardization phase, which consists in the daily bathing for two weeks with a antiseptic free soap and shampoo. Likewise would avoid chemical showers such as swimming. At the end of this phase a quantification of skin flora will be perform.

Control bath

Intervention Type PROCEDURE

Volunteers will be ask to perform full body bath with wipes without impregnation for 3 to 5 days, each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.

Interventions

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Standardization phase

Prior the principal intervention, each volunteer should complete a standardization phase, which consists in the daily bathing for two weeks with a antiseptic free soap and shampoo. Likewise would avoid chemical showers such as swimming. At the end of this phase a quantification of skin flora will be perform.

Intervention Type PROCEDURE

Control bath

Volunteers will be ask to perform full body bath with wipes without impregnation for 3 to 5 days, each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.

Intervention Type PROCEDURE

Bath with chlorhexidine

Volunteers will be asked to perform full body bath with wipes with 2% chlorhexidine impregnation and with 0.15% chlorhexidine shampoo (for the head and genitalia) for 3 to 5 days. Each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.

Intervention Type PROCEDURE

Other Intervention Names

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Skin flora standarization

Eligibility Criteria

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Inclusion Criteria

* Healthy adult volunteer

Exclusion Criteria

* History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G70 antisepsis

UNKNOWN

Sponsor Role collaborator

Universidad de Guanajuato

OTHER

Sponsor Role lead

Responsible Party

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Alejandro E. Macias

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro E Macias, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Guanajuato

Juan L Mosqueda, MD

Role: STUDY_DIRECTOR

Universidad de Guanajuato

Ruth C Morales, MD

Role: STUDY_CHAIR

Universidad de Guanajuato

Virginia Arreguin, MD

Role: STUDY_CHAIR

Universidad de Guanajuato

Jose A Alvarez, MD

Role: STUDY_CHAIR

Universidad de Guanajuato

Juan M Munoz, MD

Role: STUDY_CHAIR

Universidad de Guanajuato

Juan H Macias, MD

Role: STUDY_CHAIR

Universidad de Guanajuato

Locations

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General Hospital of Leon

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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GTSSA002101245

Identifier Type: -

Identifier Source: org_study_id