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

Phase 4

Completed

• Conditions: Bed Bathing
• Interventions: Procedure: Standardization phase; Procedure: Control bath; Procedure: Bath with chlorhexidine

• Registration Number: NCT02096094
• Lead Sponsor: Universidad de Guanajuato

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Healthy adult volunteer

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control bath	Control bath	This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine.
Chlorhexidine bath	Bath with chlorhexidine	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.
Chlorhexidine bath	Standardization phase	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.
Control bath	Standardization phase	This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine.

Primary Outcome Measures

Name	Time	Method
Skin reaction to chlorhexidine	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of bacterial colony count of skin.	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.

Trial Locations

Locations (1)

General Hospital of Leon; 🇲🇽 Leon, Guanajuato, Mexico