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

Universidad de Guanajuato

Status and phase: Completed; Phase 4

Conditions: Bed Bathing

Treatments: Procedure: Control bath; Procedure: Bath with chlorhexidine; Procedure: Standardization phase

Study type: Interventional

Funder types: Other

Identifiers

NCT02096094

GTSSA002101245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteer

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Chlorhexidine bath

Experimental group

Description:

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.

Treatment:

Procedure: Standardization phase

Procedure: Bath with chlorhexidine

Control bath

Placebo Comparator group

Description:

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

Treatment:

Procedure: Control bath

Procedure: Standardization phase