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

November 30, 2015 updated by: Alejandro E. Macias, Universidad de Guanajuato
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37320
        • General Hospital of Leon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult volunteer

Exclusion Criteria:

  • History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
Other Names:
  • Skin flora standarization
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.
PLACEBO_COMPARATOR: Control bath
This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine.
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.
Other Names:
  • Skin flora standarization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin reaction to chlorhexidine
Time Frame: 24 hours
Presence of any cutaneous reaction in the first 24 hours after bathing with chlorhexidine. If the volunteers develop any skin reaction, a blinded dermatologist will evaluate it, and will perform a susceptibility test to determine if skin reaction is related to the antiseptic.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of bacterial colony count of skin.
Time Frame: 24 hours
Comparison of bacterial colony counts of skin after and before the intervention. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin for each bacterial colony count.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Collaborators

G70 antisepsis

Investigators

  • Study Director: Juan L Mosqueda, MD, Universidad de Guanajuato
  • Study Chair: Ruth C Morales, MD, Universidad de Guanajuato
  • Study Chair: Virginia Arreguin, MD, Universidad de Guanajuato
  • Study Chair: Jose A Alvarez, MD, Universidad de Guanajuato
  • Study Chair: Juan M Munoz, MD, Universidad de Guanajuato
  • Study Chair: Juan H Macias, MD, Universidad de Guanajuato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTSSA002101245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bed Bathing

Clinical Trials on Standardization phase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe