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| Name | Class |
|---|---|
| G70 antisepsis | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine bath | Experimental | 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. |
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| Control bath | Placebo Comparator | This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardization phase | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro E Macias, MD | Universidad de Guanajuato | Principal Investigator |
| Juan L Mosqueda, MD | Universidad de Guanajuato | Study Director |
| Ruth C Morales, MD | Universidad de Guanajuato | Study Chair |
| Virginia Arreguin, MD | Universidad de Guanajuato | Study Chair |
| Jose A Alvarez, MD | Universidad de Guanajuato | Study Chair |
| Juan M Munoz, MD | Universidad de Guanajuato | Study Chair |
| Juan H Macias, MD | Universidad de Guanajuato | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Leon | León | Guanajuato | 37320 | Mexico |
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| ID | Term |
|---|---|
| D001494 | Baths |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001452 | Balneology |
| D013812 | Therapeutics |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 |
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| Control bath | Procedure | 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. |
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| Bath with chlorhexidine | Procedure | 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. |
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| Amidines |
| D009930 | Organic Chemicals |