General Hospital of Leon
León, Guanajuato, 37320, Mexico
Completed
NCT Number: NCT02096094
A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy adult volunteer
Exclusion criteria
- History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.
Treatment and study plan
Standardization phase
ProcedurePrior 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.
Other names: Skin flora standarization
Control bath
ProcedureVolunteers 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.
Bath with chlorhexidine
ProcedureVolunteers 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.
Primary outcomes
-
Skin reaction to chlorhexidine
Time frame: 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 outcomes
-
Comparison of bacterial colony count of skin.
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Universidad de Guanajuato
Other
Collaborators
- G70 antisepsis
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Mar 26, 2014
- Registry last updated
- Dec 2, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.