Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:44 PM
Study NCT ID:
NCT00799812
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2008-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Test for Pre Operative Skin Preparations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002864', 'term': 'Chromogranins'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}], 'ancestors': [{'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erin.zook@bd.com', 'phone': '847-362-9047', 'title': 'Erin Zook', 'organization': 'BD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the study through the 6-hour time point evaluations', 'eventGroups': [{'id': 'EG000', 'title': 'CHG Swabstick (3 @ Once)', 'description': 'Chlorhexidine gluconate (CHG) 2% CHG/isopropyl alcohol (IPA) 70%-3 swabsticks applied @ same time\n\nCHG 2% w/v \\& IPA 70% v/v, swabstick (3 @ once): 3 swabsticks topically applied at the same time to intact skin', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CHG Swabstick Sequential', 'description': 'Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v--3 swabsticks applied sequentially\n\nCHG 2% w/v \\& IPA 70% v/v swabstick: 3 swabsticks applied sequentially to intact skin.', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 0, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hibiclens', 'description': "Chlorhexidine gluconate 4% w/v in an aqueous base\n\nAqueous CHG 4% w/v applied according to manufacturer's directions: Step 1) 5 mL of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.", 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sterile Water Swab (3 @ Once)', 'description': 'Sterile swabstick wetted with sterile deionized water--3 swabsticks applied at the same time.\n\nSterile swabstick with sterile deionized water (3 @ once): 3 swabsticks wetted with sterile water topically applied to intact skin at the same time.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Sterile Water Swabstick (Sequential)', 'description': 'Sterile swabstick wetted with sterile deionized water--3 swabsticks applied sequentially.\n\nSterile swabstick with sterile deionized water (sequentially): swabsticks wetted with sterile water topically applied to intact skin sequentially.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}, {'units': 'Number of Sites Analyzed', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '251', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CHG Swabstick (3 @ Once)', 'description': 'Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time\n\nCHG 2% w/v \\& IPA 70% v/v, swabstick (3 @ once).: 3 swabsticks topically applied at the same time to intact skin'}, {'id': 'OG001', 'title': 'CHG Swabstick Sequential', 'description': 'Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially\n\nCHG 2% w/v \\& IPA 70% v/v swab applied sequentially: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.'}, {'id': 'OG002', 'title': 'Hibiclens', 'description': "Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base\n\nAqueous CHG 4% w/v applied according to mfr's directions: Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated."}, {'id': 'OG003', 'title': 'Sterile Water Swab (3 @ Once)', 'description': 'Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.\n\nSterile swabstick with sterile water (3 @ once): 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.'}, {'id': 'OG004', 'title': 'Sterile Water Swabstick (Sequential)', 'description': 'Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.\n\nSterile swabstick with sterile water (one-at-a-time): Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.'}], 'classes': [{'title': 'Groin site - 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}, {'units': 'Number of Sites Analyzed', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.51', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '3.15', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '0.92', 'spread': '0.47', 'groupId': 'OG003'}, {'value': '0.97', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Groin site - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}, {'units': 'Number of Sites Analyzed', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '2.89', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '0.82', 'spread': '0.47', 'groupId': 'OG003'}, {'value': '0.85', 'spread': '0.58', 'groupId': 'OG004'}]}]}, {'title': 'Abdomen site - 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}, {'units': 'Number of Sites Analyzed', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '2.76', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '0.37', 'groupId': 'OG003'}, {'value': '0.50', 'spread': '0.35', 'groupId': 'OG004'}]}]}, {'title': 'Abdomen site - 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}, {'units': 'Number of Sites Analyzed', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '2.51', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '0.47', 'spread': '0.38', 'groupId': 'OG003'}, {'value': '0.46', 'spread': '0.39', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes and 6 hours after application of test solutions', 'description': 'The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.', 'unitOfMeasure': 'Average log10 reductions in CFU/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Sites Analyzed', 'denomUnitsSelected': 'Number of Sites Analyzed', 'populationDescription': 'Measure Analysis Population Description: Number analyzed is not equal to participants treated but rather equal to the number of treated sites for individuals who met the baseline bacterial load criteria on treatment day'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Study Participants that were treated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1324', 'numSubjects': '335'}]}, {'type': 'CHG Swabstick (3 @ Once)', 'achievements': [{'groupId': 'FG000', 'numUnits': '276', 'numSubjects': '139'}]}, {'type': 'CHG Swabstick Sequential', 'achievements': [{'groupId': 'FG000', 'numUnits': '273', 'numSubjects': '138'}]}, {'type': 'Hibiclens', 'achievements': [{'groupId': 'FG000', 'numUnits': '264', 'numSubjects': '133'}]}, {'type': 'Sterile Water Swab (3 @ Once)', 'achievements': [{'groupId': 'FG000', 'numUnits': '260', 'numSubjects': '132'}]}, {'type': 'Sterile Water Swabstick (Sequential)', 'achievements': [{'groupId': 'FG000', 'numUnits': '251', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1324', 'numSubjects': '335'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Treated Sites', 'preAssignmentDetails': 'Each subject received more than one treatment. Randomization was done by testing site and each subject had 4 testing sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All Participants Who Completed Evaluations'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '14.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'All Participants', 'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '186', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '371-121 Preoperative Skin Preparations', 'classes': [{'title': 'CHG Swabstick (3 @ Once)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}]}]}, {'title': 'CHG Swabstick (Sequential)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}]}]}, {'title': 'Hibiclens', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}, {'title': 'Sterile Water Swab (3 @ Once)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}, {'title': 'Sterile Water Swabstick (Sequential)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Note: Participants received 2 of the 5 study products. One product is applied to on the left abdomen and groin and one product is applied on the right abdomen and groin.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants treated in the study with adequate baseline bacterial load.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2007-08-24', 'size': 767970, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-28T09:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2008-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2008-11-26', 'resultsFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2008-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-05-26', 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites', 'timeFrame': '10 minutes and 6 hours after application of test solutions', 'description': 'The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antimicrobial', 'antisepsis'], 'conditions': ['Topical Antisepsis']}, 'descriptionModule': {'briefSummary': "Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.", 'detailedDescription': "Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.\n\nStudy uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must read and sign an Informed Consent Form and be cooperative.\n* Subjects must be in good general health.\n* Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.\n\nExclusion Criteria:\n\n* Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.\n* A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.\n* Any medical condition that in the opinion of the investigator would preclude participation.\n* Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.\n* Used UV tanning lamps 2 weeks prior to any microbial sampling.\n* Bathing or showering less than 48 hours prior to any microbial sampling.\n* Known sensitivity to chlorhexidine gluconate.\n* Known sensitivity to latex (rubber).\n* Known sensitivity to fragrances.\n* Pregnant or nursing.\n* Unwillingness to fulfill the performance requirements of the study.\n* Subjects who have completed part or all of the study will not be reentered in the study.'}, 'identificationModule': {'nctId': 'NCT00799812', 'briefTitle': 'Test for Pre Operative Skin Preparations', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)', 'orgStudyIdInfo': {'id': 'ENT 371-121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHG Swabstick (3 @ once)', 'description': 'Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time', 'interventionNames': ['Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).']}, {'type': 'EXPERIMENTAL', 'label': 'CHG Swabstick sequential', 'description': 'Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially', 'interventionNames': ['Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hibiclens', 'description': 'Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base', 'interventionNames': ["Drug: Aqueous CHG 4% w/v applied according to mfr's directions"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile water swab (3 @ once)', 'description': 'Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.', 'interventionNames': ['Other: Sterile swabstick with sterile water (3 @ once)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile water swabstick (sequential)', 'description': 'Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.', 'interventionNames': ['Other: Sterile swabstick with sterile water (one-at-a-time)']}], 'interventions': [{'name': 'CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).', 'type': 'DRUG', 'otherNames': ['ChloraPrep Swabstick'], 'description': '3 swabsticks topically applied at the same time to intact skin', 'armGroupLabels': ['CHG Swabstick (3 @ once)']}, {'name': 'CHG 2% w/v & IPA 70% v/v swab applied sequentially', 'type': 'DRUG', 'otherNames': ['ChloraPrep Swabstick'], 'description': 'Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.', 'armGroupLabels': ['CHG Swabstick sequential']}, {'name': "Aqueous CHG 4% w/v applied according to mfr's directions", 'type': 'DRUG', 'otherNames': ['Hibiclens'], 'description': "Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.", 'armGroupLabels': ['Hibiclens']}, {'name': 'Sterile swabstick with sterile water (3 @ once)', 'type': 'OTHER', 'description': '3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.', 'armGroupLabels': ['Sterile water swab (3 @ once)']}, {'name': 'Sterile swabstick with sterile water (one-at-a-time)', 'type': 'OTHER', 'description': 'Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.', 'armGroupLabels': ['Sterile water swabstick (sequential)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20164', 'city': 'Sterling', 'state': 'Virginia', 'country': 'United States', 'facility': 'Microbiotest', 'geoPoint': {'lat': 39.00622, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'M. Hamid Bashir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}