Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02443792
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Unicirc vs Open Surgical Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014014', 'term': 'Tissue Adhesives'}, {'id': 'D061887', 'term': 'Conversion to Open Surgery'}], 'ancestors': [{'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'justintshenje@gmail.com', 'phone': '0027788938497', 'title': 'Dr. Justin Shenje', 'organization': 'U of Cape Town'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Any any time during study (4-6 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above', 'otherNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-op bleeding', 'notes': 'Bleeding requiring sutures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraoperative bleeding requiring sutures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'OG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '17'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 30 minutes', 'description': 'Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Pain 0=no Pain; 10=Worst Pain Ever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'OG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 minutes', 'description': 'Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Completely Healed at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'OG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the 4-week followup visit', 'description': 'Number of participants who were completely healed at 4 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wound Dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'OG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'classes': [{'title': 'Dehiscence > 2 cm longitudinally', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dehiscence < 2 cm longitudinally', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Proportion experiencing wound dehiscence (\\< 2 cm vs \\> 2 cm)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'OG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Proportion experiencing post-op infection, determined clinically (treated with antibiotics)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'FG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unicirc With Tissue Adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing\n\nUnicirc with tissue adhesive: As above'}, {'id': 'BG001', 'title': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing\n\nOpen Surgical: As above'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18-25', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Age 26-35', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Age 36+', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2015-04-10', 'resultsFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-13', 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing', 'timeFrame': 'Up to 30 minutes', 'description': 'Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing'}], 'secondaryOutcomes': [{'measure': 'Surgical Pain 0=no Pain; 10=Worst Pain Ever', 'timeFrame': 'Up to 30 minutes', 'description': 'Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever'}, {'measure': 'Completely Healed at 4 Weeks', 'timeFrame': 'At the 4-week followup visit', 'description': 'Number of participants who were completely healed at 4 weeks'}, {'measure': 'Wound Dehiscence', 'timeFrame': 'Up to 4 weeks', 'description': 'Proportion experiencing wound dehiscence (\\< 2 cm vs \\> 2 cm)'}, {'measure': 'Infection', 'timeFrame': 'Up to 4 weeks', 'description': 'Proportion experiencing post-op infection, determined clinically (treated with antibiotics)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Circumcision, Male']}, 'referencesModule': {'references': [{'pmid': '25822727', 'type': 'BACKGROUND', 'citation': 'Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.'}, {'pmid': '27299735', 'type': 'DERIVED', 'citation': 'Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male\n* Uncircumcised\n* With normal penile anatomy\n\nExclusion Criteria:\n\n* Concurrent illness\n* History of bleeding disorder\n* Past reaction to local anesthetic\n* Infection\n* Penile abnormality which could complicate circumcision'}, 'identificationModule': {'nctId': 'NCT02443792', 'acronym': 'Unicirc004', 'briefTitle': 'Unicirc vs Open Surgical Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Simunye Primary Health Care'}, 'officialTitle': 'Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Unicirc004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unicirc with tissue adhesive', 'description': 'Unicirc under topical anesthetic w/ cyanoacrylate wound sealing', 'interventionNames': ['Procedure: Unicirc with tissue adhesive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Surgical', 'description': 'Open surgical circumcision under local anesthetic with suturing', 'interventionNames': ['Procedure: Open Surgical']}], 'interventions': [{'name': 'Unicirc with tissue adhesive', 'type': 'PROCEDURE', 'description': 'As above', 'armGroupLabels': ['Unicirc with tissue adhesive']}, {'name': 'Open Surgical', 'type': 'PROCEDURE', 'description': 'As above', 'armGroupLabels': ['Open Surgical']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marikana', 'state': 'Northwest', 'country': 'South Africa', 'facility': 'Lonmin Hospital', 'geoPoint': {'lat': -25.699, 'lon': 27.47475}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simunye Primary Health Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Justin Shenje, MB ChB', 'investigatorAffiliation': 'University of Cape Town'}}}}