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

Bed Bathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096094
• Other study ID #: GTSSA002101245
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2014
• Last updated: November 30, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2014
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adult volunteer

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bed Bathing

Intervention

Procedure:
• Standardization phase
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.
• Control bath
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.
• Bath with chlorhexidine
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.

Locations

Country	Name	City	State
Mexico	General Hospital of Leon	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Guanajuato	G70 antisepsis

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes