Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 4:57 AM
Study NCT ID:
NCT00863356
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jody.oyama@hemcon.com', 'phone': '971.223.4904', 'title': 'V.P., Clinical Affairs', 'organization': 'HemCon Medical Technologies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Epistaxis Group', 'description': "Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.\n\nOne week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.', 'timeFrame': 'Removal: 48 hours. Follow-up: 1 week.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.', 'timeFrame': 'Removal: 48 hours. Follow-up: 1 week.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Hemostasis Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epistaxis Group', 'description': "Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.\n\nOne week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From procedure to hemostasis.', 'description': "Successful hemostasis prior to leaving physician's office", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epistaxis Group', 'description': "Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.\n\nOne week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from a tertiary rhinology fellowship training clinic from January 2009 to November 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Epistaxis Group', 'description': "Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.\n\nOne week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-29', 'studyFirstSubmitDate': '2009-03-16', 'resultsFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-29', 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.', 'timeFrame': 'Removal: 48 hours. Follow-up: 1 week.'}, {'measure': 'Hemostasis Success', 'timeFrame': 'From procedure to hemostasis.', 'description': "Successful hemostasis prior to leaving physician's office"}], 'secondaryOutcomes': [{'measure': 'This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.', 'timeFrame': 'Removal: 48 hours. Follow-up: 1 week.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epistaxis', 'Chitosan', 'Hemostatic', 'Nose bleed', 'Nasal bleeding', 'Nasal pack', 'Sealant', 'ChitoFlex®', 'HemCon', 'HemCon® ChitoFlex Surgical Dressing', 'HemCon® Nasal Plugs', 'Biocompatible dressing'], 'conditions': ['Epistaxis']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nThis study is a prospective clinical trial to investigate the efficacy of a chitosan-coated nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management of difficult spontaneous epistaxis and to evaluate its healing effect on nasal mucosa.\n\nThe introduction of products that enhances hemostasis can have clinical advantages when associated with traditional nasal packing. These advantages include a better hemostatic control and the reduction of nasal packing duration. Furthermore, this study will help determine if there are any non-desirable effects that chitosan may have on the nasal cavity, such as the production of fibrosis and foreign body reaction.', 'detailedDescription': 'Epistaxis is a common reason for emergency department visits and otolaryngology referral. Management methods of epistaxis include nasal packing, chemical or electric cauterization, and arterial ligation or embolization.\n\nThere are numerous nasal packing products available in the market, and are used to stop or prevent nasal bleeding. The ideal nasal pack should be efficient in controlling bleeding, have antimicrobial properties and be well tolerated. Currently, there is no perfect nasal pack, but some are closer to ideal than others. Nasal packs can be classified into non-absorbable and absorbable nasal packs.\n\nRecently, a new hemostatic product has been introduced in the market, and used as a military wound bandages, the ChitoFlex®. ChitoFlex® is made of chitosan, a naturally occurring, bio-compatible polysaccharide. Because chitosan has a positive charge, it attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, coherent seal. The ChitoFlex® -dressing has been demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) as an antibacterial barrier in laboratory testing with a variety of gram-positive and gram-negative bacterial organisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of 18 years.\n* Epistaxis despite nasal packing or rebleeding after removal of the packing.\n\nExclusion Criteria:\n\n* Patient unable or unwilling to provide informed consent.\n* Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.)'}, 'identificationModule': {'nctId': 'NCT00863356', 'briefTitle': 'Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemCon Medical Technologies, Inc'}, 'officialTitle': 'Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis', 'orgStudyIdInfo': {'id': '2009-I-Epistaxis-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epistaxis Group', 'description': "Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.\n\nOne week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.", 'interventionNames': ['Device: 2009-I-Epistaxis-1']}], 'interventions': [{'name': '2009-I-Epistaxis-1', 'type': 'DEVICE', 'otherNames': ['Epistaxis', 'Chitosan', 'Chitin', 'Hemostatic', 'Nose bleed', 'Nasal bleeding', 'Nasal pack', 'Sealant', 'ChitoFlex®', 'HemCon', 'HemCon® ChitoFlex Surgical Dressing', 'HemCon® Nasal Plugs', 'biocompatible polysaccharide'], 'description': 'Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.', 'armGroupLabels': ['Epistaxis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Memorial Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Alan H. Shikani, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemCon Medical Technologies, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}