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

Summary

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.

Conditions

• Bed Bathing

Interventions

PROCEDURE

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.

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.

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.

Sponsors & Collaborators

• G70 antisepsis

  collaborator UNKNOWN

• Universidad de Guanajuato

  lead OTHER

Principal Investigators

• Alejandro E Macias, MD · Universidad de Guanajuato

• Juan L Mosqueda, MD · Universidad de Guanajuato

• Ruth C Morales, MD · Universidad de Guanajuato

• Virginia Arreguin, MD · Universidad de Guanajuato

• Jose A Alvarez, MD · Universidad de Guanajuato

• Juan M Munoz, MD · Universidad de Guanajuato

• Juan H Macias, MD · Universidad de Guanajuato

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2014-09-30

Completion

2015-01-31

Countries

• Mexico

Study Locations