Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-03 @ 4:21 PM
Study NCT ID:
NCT03001102
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Bath in Patients Submitted to Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000028', 'term': 'Abortion, Induced'}], 'ancestors': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection of Surgical Site (SSI)', 'timeFrame': 'During the first 90 days after surgery', 'description': 'The infections that develop after the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Allergic reactions', 'timeFrame': 'In the first hours after procedure', 'description': 'Adverse reaction to a given product'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preoperative Care', 'Baths', 'Chlorhexidine', 'Soaps', 'Povidone-Iodine', 'Arthroplasty, Replacement, Hip', 'Surgical Wound Infection'], 'conditions': ['Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.', 'detailedDescription': 'Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.\n\nThe expected result is lower ISC rate with the proposed measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18 or older;\n* Elective procedure of total hip arthroplasty\n* No report of infectious focus at the surgical site\n* Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability\n* Do not be a nasal carrier of Staphylococcus aureus before surgery\n* Have access to fixed or mobile phone\n\nExclusion Criteria:\n\n* Patient treating surgical site infection\n* Emergency hip prosthesis surgery or orthopedic trauma\n* Nasal carriers of Staphylococcus aureus before surgery\n* Previous history of allergic reactions to the products used in the bat'}, 'identificationModule': {'nctId': 'NCT03001102', 'briefTitle': 'Preoperative Bath in Patients Submitted to Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EE-UFMG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Bathing with 4% Chlorhexidine gluconate', 'description': 'Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.', 'interventionNames': ['Device: 4% Chlorhexidine gluconate']}, {'type': 'EXPERIMENTAL', 'label': 'Bathing with10% PVPI degermante', 'description': 'Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.', 'interventionNames': ['Device: 10% PVPI degermante']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bathing with soap without antiseptic.', 'description': 'Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.', 'interventionNames': ['Device: Soap without antiseptic']}], 'interventions': [{'name': '4% Chlorhexidine gluconate', 'type': 'DEVICE', 'otherNames': ['HiBiScrub', '4% Chlorhexidine degermante'], 'description': 'Cationic biguanide - antimicrobial action rubbing in the skin.', 'armGroupLabels': ['Bathing with 4% Chlorhexidine gluconate']}, {'name': '10% PVPI degermante', 'type': 'DEVICE', 'otherNames': ['Betadine', '10% Povidone iodine degermante'], 'description': 'Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.', 'armGroupLabels': ['Bathing with10% PVPI degermante']}, {'name': 'Soap without antiseptic', 'type': 'DEVICE', 'otherNames': ['Non-medicated soap', 'Soap'], 'description': 'Liquid soap with glycerin, neutral pH. Skin cleansing', 'armGroupLabels': ['Bathing with soap without antiseptic.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Lúcia MC Franco, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do estado de Minas Gerais', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Lucia Maciel de Castro Franco', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}