Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT01253135
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2010-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Determine if Fibrin Affects the Ability of a Wound to Heal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jaime.Dickerson@smith-nephew.com', 'phone': '1-817-302-3914', 'title': 'Jaime E Dickerson, PhD', 'organization': 'Smith & Nephew'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety reporting occurred over the three weeks of the treatment period.', 'description': 'All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'White Petrolatum\n\nWhite Petrolatum: Topical application\n\nWhite petrolatum was applied daily to the appropriate wound.', 'otherNumAtRisk': 40, 'otherNumAffected': 18, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Article', 'description': '802-247 Vehicle (fibrinogen)\n\nFibrin: Topical application of fibrinogen spray, followed by thrombin spray\n\nHP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature.', 'otherNumAtRisk': 40, 'otherNumAffected': 18, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders & administrative site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Injury, poisoning & procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Musculoskeletal & connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Skin & subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 29, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'White Petrolatum\n\nWhite Petrolatum: Topical application\n\nWhite petrolatum was applied daily to the appropriate wound.'}, {'id': 'OG001', 'title': 'Test Article', 'description': '802-247 Vehicle (fibrinogen)\n\nFibrin: Topical application of fibrinogen spray, followed by thrombin spray\n\nHP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3393', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.08', 'ciUpperLimit': '0.84', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.7', 'estimateComment': 'The Confidence Interval was based on a t-distribution', 'statisticalMethod': 'Prentice-Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22', 'description': 'The target wounds were evaluated wound status (open/closed).', 'unitOfMeasure': 'days to wound closure', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data.'}, {'type': 'PRIMARY', 'title': 'Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Article', 'description': '802-247 Vehicle (fibrinogen)\n\nFibrin: Topical application of fibrinogen spray, followed by thrombin spray\n\nHP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature.'}, {'id': 'OG001', 'title': 'Control', 'description': 'White Petrolatum\n\nWhite Petrolatum: Topical application\n\nWhite petrolatum was applied daily to the appropriate wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '.4771', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Testing was by a Log Rank test with significance being at P \\< 0.05', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22', 'description': 'The target wounds were evaluated wound status (open/closed)', 'unitOfMeasure': 'days to closure', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.'}], 'periods': [{'title': 'Original Protocol', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Protocol Amendment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}, {'title': 'Amended Protocol', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at a single US investigation site, between February 2, 2011 and July 5, 2011.', 'preAssignmentDetails': 'Subjects who met all inclusion/exclusion criteria received paired superficial thermal injuries, one on the ventral aspect of each forearm, using liquid nitrogen. The test article applied to each arm was determined by randomization code. Wound status (closed/open) was assessed by a blinded assessor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age for all 40 participants', 'categories': [{'measurements': [{'value': '30.7', 'spread': '10.2', 'groupId': 'BG000'}]}]}, {'title': 'Age for only amended protocol participants', 'categories': [{'measurements': [{'value': '32.8', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male entire study population', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Female entire study population', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Male amended protocol', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Female amended protocol', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Non Hispanic/Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'For amended protocol participants', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'There were 40 participants in the entire study. Only 25 participants in the amended protocol'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], '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': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2010-11-30', 'resultsFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-17', 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.', 'timeFrame': 'All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22', 'description': 'The target wounds were evaluated wound status (open/closed).'}, {'measure': 'Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.', 'timeFrame': 'All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22', 'description': 'The target wounds were evaluated wound status (open/closed)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibrin, white petrolatum, wound healing'], 'conditions': ['Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray']}, 'referencesModule': {'references': [{'pmid': '26151791', 'type': 'DERIVED', 'citation': 'Vivas A, Fox JD, Baquerizo Nole KL, Maderal AD, Badiavas E, Cargill DI, Slade HB, Feldman SR, Kirsner RS. Cryo-Induced Thermal Wounds: A Human Acute Wound Model. J Drugs Dermatol. 2015 Jul;14(7):734-8.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.\n* Are male or female, ≥ 18 years of age, of any race.\n* Are willing to attend all required study visits, and to comply with study procedures.\n* Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study.\n\nExclusion Criteria:\n\n* Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosus, discoid lupus, Ehler Danlos disease, icthyosis vulgaris, vasculitis, or bleeding disorders (coagulopathies).\n* Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis, or Vitiligo.\n* Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).\n* Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).\n* Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.\n* Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.\n* Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids, or chemical peel agents in the treatment areas.\n* Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.\n* The Principal Investigator may declare any subject ineligible for a valid medical reason."}, 'identificationModule': {'nctId': 'NCT01253135', 'briefTitle': 'Study to Determine if Fibrin Affects the Ability of a Wound to Heal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'An Open-label, Randomized, Evaluator-Blinded Study of the Effect of Polymerized Fibrin Applied Topically Once Per Week, on Healing of Induced Thermal Wounds, Versus Weekly Application of White Petrolatum', 'orgStudyIdInfo': {'id': '802-247-09-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'White Petrolatum', 'interventionNames': ['Other: White Petrolatum']}, {'type': 'OTHER', 'label': 'Test article', 'description': 'Vehicle (fibrinogen)', 'interventionNames': ['Biological: Fibrin']}], 'interventions': [{'name': 'Fibrin', 'type': 'BIOLOGICAL', 'description': 'Topical application of fibrinogen spray, followed by thrombin spray', 'armGroupLabels': ['Test article']}, {'name': 'White Petrolatum', 'type': 'OTHER', 'description': 'Topical application', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Dept of Dermatology, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}