Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT00165958
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004814', 'term': 'Epidermal Cyst'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schen2@emory.edu', 'phone': '4047783084', 'title': 'Dr. Suephy Chen', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The limitations of this study include the small, predominately male patient population, lack of complete follow-up of secondary endpoint measurements at every time point.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Punch Incision', 'description': 'Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traditional Excision', 'description': 'Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Cyst Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Punch Incision', 'description': 'Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool'}, {'id': 'OG001', 'title': 'Traditional Excision', 'description': 'Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'Recurrence of cyst after removal', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Punch Excision', 'description': 'Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool'}, {'id': 'FG001', 'title': 'Traditional Excision', 'description': 'Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'subjects older than 18 years of age with 1-3 cm truncal EICs were selected via serial recruitment from the Atlanta Veterans Affairs Medical Center Dermatology clinic', 'preAssignmentDetails': 'Patients were excluded if the cysts were inflamed, infected, or ruptured based on characteristic physical examination findings.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Punch Excision', 'description': 'Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool'}, {'id': 'BG001', 'title': 'Traditional Excision', 'description': 'Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-11', 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cyst Recurrence', 'timeFrame': '16 months', 'description': 'Recurrence of cyst after removal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidermal cyst', 'Epidermoid cyst', 'Sebaceous cyst', 'Pilar cyst'], 'conditions': ['Epidermal Cyst']}, 'descriptionModule': {'briefSummary': "The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.", 'detailedDescription': "The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.\n\nPatients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years or older\n* Epidermal cyst 1-3 cm in diameter on the trunk\n\nExclusion Criteria:\n\n* Infected cyst requiring systemic antibiotics\n* Pregnant females\n* Unable to return to clinic for suture removal\n* Previous excision of target cyst'}, 'identificationModule': {'nctId': 'NCT00165958', 'briefTitle': 'Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts', 'orgStudyIdInfo': {'id': '1023-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Punch excision', 'interventionNames': ['Procedure: Punch incision of epidermal cyst']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional excision', 'interventionNames': ['Procedure: Excisional surgery of epidermal cyst']}], 'interventions': [{'name': 'Excisional surgery of epidermal cyst', 'type': 'PROCEDURE', 'description': 'Traditional extirpation of cyst en toto', 'armGroupLabels': ['Traditional excision']}, {'name': 'Punch incision of epidermal cyst', 'type': 'PROCEDURE', 'description': 'removal of cyst first with incisional effort with a punch biopsy tool', 'armGroupLabels': ['Punch excision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'overallOfficials': [{'name': 'Suephy C Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Department of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Suephy Chen, MD', 'investigatorAffiliation': 'Emory University'}}}}