Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT00855569
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2009-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostatic Textile to Control Bleeding at Donor Graft Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding.', 'timeFrame': 'At the time of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allografting'], 'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': 'The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the UNC Jaycee Burn Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 18 years old\n* burn injury requiring allografting from donor site\n\nExclusion Criteria:\n\n* \\< 18 years\n* unable to give consent due to mental or emotional instability'}, 'identificationModule': {'nctId': 'NCT00855569', 'acronym': 'Stasilon', 'briefTitle': 'Hemostatic Textile to Control Bleeding at Donor Graft Sites', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)', 'orgStudyIdInfo': {'id': 'PREN-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made', 'interventionNames': ['Device: Stasilon']}], 'interventions': [{'name': 'Stasilon', 'type': 'DEVICE', 'description': 'Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Jaycee Burn Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Preston Rich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}