Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-14 @ 5:31 AM
Study NCT ID:
NCT02704104
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2016-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jprats@archtherapeutics.com', 'phone': '617 431-2313', 'title': 'Medical/Scientific Affairs', 'organization': 'Arch Therapeutics, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.', 'eventGroups': [{'id': 'EG000', 'title': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion\n\nAC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 13, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion\n\nAC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 13, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Secretion discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Wound hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days Post Procedure', 'description': 'Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.\n\nSystemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Hemostasis (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '165'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '387'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of application (Day 0)', 'description': 'Measure of time from application of treatment or control to the wound, to bleeding cessation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.'}, {'type': 'SECONDARY', 'title': 'Time to Hemostasis in Seconds Per Square Centimeter Wound Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1100'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '797'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of application (Day 0)', 'description': 'Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area', 'unitOfMeasure': 'seconds/cm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.'}, {'type': 'SECONDARY', 'title': 'Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wounds Treated With AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of wounds'}, {'id': 'OG001', 'title': 'Wounds Treated With Control', 'description': 'The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to wounds'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 and 30 Days Post Procedure', 'description': 'The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and \\>40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.', 'unitOfMeasure': 'wounds', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions'}], 'classes': [{'title': 'Taking antiplatelet therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '120'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '387'}]}]}, {'title': 'Not taking antiplatelet therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '165'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '244'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of patients is 46, 10 of whom were taking anti platelet therapy at the time of the procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All study participants had two freshly excised lesions, each randomized to either application of a topical hemostatic device (AC5) or control (saline) treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited who were to undergo excision of two skin lesions in the same sitting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Characteristics of the 46 patients enrolled in the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '15.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ireland', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Antiplatelet therapy', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2016-03-01', 'resultsFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-06', 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication', 'timeFrame': 'Day 0'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up', 'timeFrame': '30 Days Post Procedure', 'description': 'Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.\n\nSystemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.'}], 'secondaryOutcomes': [{'measure': 'Median Time to Hemostasis (Seconds)', 'timeFrame': 'At time of application (Day 0)', 'description': 'Measure of time from application of treatment or control to the wound, to bleeding cessation'}, {'measure': 'Time to Hemostasis in Seconds Per Square Centimeter Wound Area', 'timeFrame': 'At time of application (Day 0)', 'description': 'Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area'}, {'measure': 'Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30', 'timeFrame': '7 and 30 Days Post Procedure', 'description': 'The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and \\>40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['topical hemostat', 'self-assembling peptide barrier'], 'conditions': ['Skin Neoplasms']}, 'referencesModule': {'references': [{'pmid': '2868173', 'type': 'RESULT', 'citation': 'Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.', 'detailedDescription': 'This is a randomized, controlled single-blind pilot study to evaluate the safety and performance of AC5 following excision of lesions from the trunk or upper limbs under local anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy.\n\nEach patient had sequential shave excision of two lesions (one treatment, one Control) at the same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized.\n\nStudy and Control treatments were administered immediately after lesion excision, followed by determination of time to hemostasis (TTH), and application of an occlusive water-resistant dressing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women between the ages of 18 and 85.\n* Voluntary written informed consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.\n* Scheduled for excision of 2 (two) or more skin lesions from their trunk or upper limbs (defined as lying below the level of the inferior border of the patient's mandible).\n* If subjects is currently prescribed an antiplatelet therapy, it must from one of the following therapies at levels as per hospital protocol:\n* Antiplatelet monotherapy with one of the following agents:\n\n * Aspirin\n * Clopidogrel (thienopyridine-class antiplatelet agent)\n * Ticagrelor\n * Dipyridamole\n* Female subjects must meet at least one of the following additional criteria:\n\n * Surgically sterile with bilateral tubal ligation or hysterectomy.\n * Post-menopausal for at least one year.\n * If of child-bearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.\n* Subjects willing to undergo pre-and post-clinical investigation blood and urine collection, physical exams and laboratory investigations.\n\nExclusion Criteria:\n\n* Active infection as demonstrated by temperature \\> 37.5 C and clinical features of active infection.\n* Wound expected to expose bone or tendon.\n* Wound expected to require topical antibiotics.\n* Know contraindication or reaction to Tegaderm use.\n* Presence of malignancy or clinical expectation of malignancy based on examination.\n* Known immunosuppression or taking immunosuppressive agents including systemic steroids.\n* Plan for adjunctive flap or graft procedure to obtain closure of the wound(s) subject to this study.\n* History of severe co-morbidity with expected patient survival ≤ 6 months.\n* Pregnancy or lactation\n* Intake of investigational drugs within 28 days prior to enrollment.\n* Currently taking oral anticoagulants\n* History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.\n* History of clinically significant, active disease (within 12 months prior to enrollment) of the pulmonary, gastrointestinal, neurological, genitourinary, renal, or haematological system, that in the opinion of the Principal Investigator, may confound the results of the trial or pose additional risk to the subject following the administration of AC5.\n* History of clinically significant cardiac disorder, defined as: acute coronary syndrome, congestive heart failure (NYHA class III/IV), diagnosis of unstable angina pectoris, cerebral stroke and or myocardial infarction within the last 12 months or planned coronary or carotid revascularisation procedures anytime through 30 Day follow-up.\n* History of severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg).\n* Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.\n* Presence of significant cognitive impairment (Mini Mental Status Examination \\<22) or mental incapacity.\n* Unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel.\n* Known or suspected active abuse of alcohol, narcotics or non-prescription drugs.\n* Other planned surgical procedures within 30 days prior to or 30 days post-index procedure.\n* Prior enrollment in this AC5 clinical trial"}, 'identificationModule': {'nctId': 'NCT02704104', 'briefTitle': 'Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arch Therapeutics'}, 'officialTitle': 'A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions', 'orgStudyIdInfo': {'id': 'AC5-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC5 Topical Hemostatic Device', 'description': 'The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion', 'interventionNames': ['Device: AC5 Topical Hemostatic Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion', 'interventionNames': ['Device: AC5 Topical Hemostatic Device']}], 'interventions': [{'name': 'AC5 Topical Hemostatic Device', 'type': 'DEVICE', 'description': 'Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient', 'armGroupLabels': ['AC5 Topical Hemostatic Device', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'country': 'Ireland', 'facility': 'University College Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Jack Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arch Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}