Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2026-01-07 @ 9:17 AM
Study NCT ID:
NCT06487494
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010688', 'term': 'Phimosis'}, {'id': 'D010263', 'term': 'Paraphimosis'}], 'ancestors': [{'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmesis', 'timeFrame': '6 and 12 weeks post-operation', 'description': 'A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation.'}, {'measure': 'Post-operative Pain', 'timeFrame': 'Immediately post-operation and 6 weeks post-operation', 'description': 'Using a visual analogue pain scale \\[range 0-10; 0 = no pain, 10 = maximal pain\\], pain will be assessed as reported by the patient to determine their pain.'}, {'measure': 'Complication Rate', 'timeFrame': '6 and 12 weeks post-operation', 'description': 'Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse.'}, {'measure': 'Intra-Operative Time', 'timeFrame': 'During the operation', 'description': 'Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phimosis', 'Paraphimosis']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.', 'detailedDescription': "This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>16 years of age undergoing circumcision will be included.\n\nExclusion Criteria:\n\n* Patients \\<16 years of age who did not provide consent to be randomized.'}, 'identificationModule': {'nctId': 'NCT06487494', 'briefTitle': 'Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Is 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures Non-inferior to Continuous Suturing as a Wound Closure Technique in Adult Male Circumcision: A Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'HS26545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2-octyl cyanoacrylate glue with four interrupted sutures', 'description': 'In this arm the provider will use 2-octyl cyanoacrylate glue with four interrupted sutures for wound closing following circumcision.', 'interventionNames': ['Procedure: Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous suture', 'description': 'In this arm the provider will use continuous suturing for wound closing following circumcision.', 'interventionNames': ['Procedure: Circumcision wound closure using continuous sutuing']}], 'interventions': [{'name': 'Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures', 'type': 'PROCEDURE', 'description': '2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure.', 'armGroupLabels': ['2-octyl cyanoacrylate glue with four interrupted sutures']}, {'name': 'Circumcision wound closure using continuous sutuing', 'type': 'PROCEDURE', 'description': 'Continuous suturing is the standard following circumcision for wound closure.', 'armGroupLabels': ['Continuous suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3K 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': "Men's Health Clinic Manitoba", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education', 'investigatorFullName': 'Premal Patel, MD', 'investigatorAffiliation': 'University of Manitoba'}}}}