Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT04756804
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2021-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perioperative Patient Skin Antiseptic Preparation Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}}}, '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': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'customercare@zurexpharma.com', 'phone': '608.203.9090', 'title': 'VP, Reg Affairs', 'organization': 'Zurex Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was a pilot study of surgical patients, the majority of which had significant comorbidities with several AEs reported in more than one patient across the study.'}}, 'adverseEventsModule': {'timeFrame': "AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).", 'eventGroups': [{'id': 'EG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'seriousEvents': [{'term': 'Cardiac Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute Blood Loss Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Heart Failure Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lactic Acidosis', 'notes': 'Outcome fatal, 2 days post op.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory Failure', 'notes': 'Outcome fatal, 2 days post op.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hepatic Failure', 'notes': 'Outcome fatal, 2 days post op.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute Circulatory Failure', 'notes': 'Outcome fatal, 2 days post op.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiogenic Shock', 'notes': 'Outcome fatal, 2 days post op.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Occlusion of Renal Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebral Hyperperfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypervolemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Altered Mental State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Surgical Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Site Infection Occurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'OG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a descriptive study, no hypothesis testing was performed.', 'otherAnalysisDescription': 'This was a descriptive study, no hypothesis testing was performed.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after surgery', 'description': 'The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Allergic Reaction and Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'OG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after surgery', 'description': 'The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis of Rates of Surgical Site Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'OG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}], 'classes': [{'categories': [{'title': 'superficial incisional infection', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'deep incisional infection', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'organ-space infection', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No surgical site infection present', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after surgery', 'description': 'Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis of Rates of Surgical Site Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'OG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}], 'classes': [{'categories': [{'title': 'Class I - Clean', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Class II - Clean-Contaminated', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after surgery', 'description': 'Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcome categorizes the results of the primary outcome - surgical site infections. The study only resulted in observation of 1 surgical site infection in one of the two interventions. Therefore, the novel prep secondary outcome results in a zero value reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'FG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation\n\n70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation'}, {'id': 'BG001', 'title': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation\n\n2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-22', 'size': 3987679, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-24T15:44', 'hasProtocol': True}, {'date': '2022-01-24', 'size': 2423246, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-24T14:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2021-02-11', 'resultsFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-20', 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection Occurrence', 'timeFrame': 'Within 30 days after surgery', 'description': 'The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.'}, {'measure': 'Allergic Reaction and Skin Irritation', 'timeFrame': 'Within 30 days after surgery', 'description': 'The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.'}], 'secondaryOutcomes': [{'measure': 'Subgroup Analysis of Rates of Surgical Site Infections', 'timeFrame': 'Within 30 days after surgery', 'description': 'Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.'}, {'measure': 'Subgroup Analysis of Rates of Surgical Site Infections', 'timeFrame': 'Within 30 days after surgery', 'description': 'Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be male or female and at least 18 years of age.\n2. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.\n3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.\n4. Expect to be available for up to 30-days after the surgery.\n\nExclusion Criteria:\n\n1. Active infection or fever including evidence of infection at or adjacent to the operative site.\n2. Immunosuppressed.\n3. Kidney/liver failure.\n4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.\n5. Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD\\&C Yellow #6.'}, 'identificationModule': {'nctId': 'NCT04756804', 'briefTitle': 'Perioperative Patient Skin Antiseptic Preparation Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zurex Pharma, Inc.'}, 'officialTitle': 'A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation', 'orgStudyIdInfo': {'id': 'ZXZP0113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '70% Isopropyl Alcohol novel preoperative skin antiseptic', 'description': '70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation', 'interventionNames': ['Drug: 70% v/v Isopropyl Alcohol Surgical Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic', 'description': '2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation', 'interventionNames': ['Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol']}], 'interventions': [{'name': '70% v/v Isopropyl Alcohol Surgical Solution', 'type': 'DRUG', 'otherNames': ['ZuraGard'], 'description': 'Patient preoperative skin preparation', 'armGroupLabels': ['70% Isopropyl Alcohol novel preoperative skin antiseptic']}, {'name': '2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol', 'type': 'DRUG', 'otherNames': ['ChloraPrep'], 'description': 'Patient preoperative skin preparation', 'armGroupLabels': ['2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'MCW/FH', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Joseph P Hart, MD, FACS, DFSVS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zurex Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}