Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 4:01 PM
Study NCT ID:
NCT02096094
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001494', 'term': 'Baths'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001452', 'term': 'Balneology'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin reaction to chlorhexidine', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comparison of bacterial colony count of skin.', 'timeFrame': '24 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antiseptics', 'Administration cutaneously', 'Chlorine compounds', 'Infection control', 'Anti-infecting agents, local'], 'conditions': ['Bed Bathing']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nChlorhexidine 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteer\n\nExclusion Criteria:\n\n* History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.'}, 'identificationModule': {'nctId': 'NCT02096094', 'briefTitle': 'A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Guanajuato'}, 'officialTitle': 'A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo', 'orgStudyIdInfo': {'id': 'GTSSA002101245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine bath', 'description': '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.', 'interventionNames': ['Procedure: Standardization phase', 'Procedure: Bath with chlorhexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control bath', 'description': 'This arm is composed with 27 healthy volunteers which will perform full body bath with wipes and shampoo without chlorhexidine.', 'interventionNames': ['Procedure: Standardization phase', 'Procedure: Control bath']}], 'interventions': [{'name': 'Standardization phase', 'type': 'PROCEDURE', 'otherNames': ['Skin flora standarization'], 'description': '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.', 'armGroupLabels': ['Chlorhexidine bath', 'Control bath']}, {'name': 'Control bath', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Control bath']}, {'name': 'Bath with chlorhexidine', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine bath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37320', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'General Hospital of Leon', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}], 'overallOfficials': [{'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', 'affiliation': 'Universidad de Guanajuato'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Guanajuato', 'class': 'OTHER'}, 'collaborators': [{'name': 'G70 antisepsis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Alejandro E. Macias', 'investigatorAffiliation': 'Universidad de Guanajuato'}}}}