Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 12:41 PM
Study NCT ID:
NCT05142969
Status:
UNKNOWN
Last Update Posted:
2021-12-29
First Post:
2021-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 247}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-11-21', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hospital-acquired infections', 'timeFrame': 'throughout study completion, an average of 7 days', 'description': 'Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).'}], 'secondaryOutcomes': [{'measure': 'Multidrug-resistant bacterial colonization free time', 'timeFrame': 'throughout study completion, an average of 7 days', 'description': 'Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chlorhexidine', 'Hospital-Acquired Infection', 'Surgery', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults (≥ 18-years old)\n* anticipated SICU stay for 48 hours or more\n* APACHE II \\>15\n\nExclusion Criteria:\n\n* Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)\n* pregnancy\n* skin irritation\n* chlorhexidine allergy\n* SICU stay of more than 48 hours prior to screening'}, 'identificationModule': {'nctId': 'NCT05142969', 'briefTitle': 'Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020ZSLC69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patients were daily bathed with soap and water only.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China).', 'interventionNames': ['Other: 2% Chlorhexidine bathing']}], 'interventions': [{'name': '2% Chlorhexidine bathing', 'type': 'OTHER', 'description': 'Eight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shining Cai', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shining Cai, PhD', 'role': 'CONTACT', 'email': 'cai.shining@zs-hospital.sh.cn', 'phone': '02164041990'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}