A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
Condition: Bed Bathing
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Standardization phase; Control bath; Bath with chlorhexidine
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Skin flora standarization
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antiseptics; Administration cutaneously; Chlorine compounds; Infection control; Anti-infecting agents, local