Clinical trial NCT02096094: A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
Official title: A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bed Bathing
Keywords: Antiseptics
Administration cutaneously
Chlorine compounds
Infection control
Anti-infecting agents, local
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: G70 antisepsis
First posted: 2014-03-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteer

Exclusion Criteria:

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

Primary outcomes:
measure: Skin reaction to chlorhexidine
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison of bacterial colony count of skin.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: General Hospital of Leon
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Alejandro E Macias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Guanajuato
name: Juan L Mosqueda, MD
role: STUDY_DIRECTOR
affiliation: Universidad de Guanajuato
name: Ruth C Morales, MD
role: STUDY_CHAIR
affiliation: Universidad de Guanajuato
name: Virginia Arreguin, MD
role: STUDY_CHAIR
affiliation: Universidad de Guanajuato
name: Jose A Alvarez, MD
role: STUDY_CHAIR
affiliation: Universidad de Guanajuato
name: Juan M Munoz, MD
role: STUDY_CHAIR
affiliation: Universidad de Guanajuato
name: Juan H Macias, MD
role: STUDY_CHAIR
References: