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

Study Overview
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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.

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

Conditions
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Bed Bathing

Intervention / Treatment
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* Procedure: Standardization phase
* Procedure: Control bath
* Procedure: Bath with chlorhexidine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine bath<br>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<br>* 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.<br>* Other names: Skin flora standarization;Procedure: Bath with chlorhexidine<br>* 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.<br>|
| Placebo Comparator: Control bath<br>This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine. | Procedure: Standardization phase<br>* 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.<br>* Other names: Skin flora standarization;Procedure: Control bath<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction to chlorhexidine | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiseptics, Administration cutaneously, Chlorine compounds, Infection control, Anti-infecting agents, local