Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 12:36 PM
Study NCT ID:
NCT02012569
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006487', 'term': 'Hemostasis'}], 'ancestors': [{'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reducing the bleeding time in the donor site of skin grafting', 'timeFrame': '10 min'}], 'secondaryOutcomes': [{'measure': 'Safety and tolertability', 'timeFrame': '1 month', 'description': 'Number of Adverse Events'}, {'measure': 'Systemic absorption of the product', 'timeFrame': '1 month', 'description': 'Cmax, Tmax, AUC and bioavailability'}, {'measure': 'Immunogenicity', 'timeFrame': '1 month', 'description': 'Antibody concentration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['skin grafting', 'elective treatment'], 'conditions': ['Burns', 'Traumatic Lesions']}, 'referencesModule': {'references': [{'pmid': '26374745', 'type': 'BACKGROUND', 'citation': 'Lopez-Lopez J, Jane-Salas E, Santamaria A, Gonzalez-Navarro B, Arranz-Obispo C, Lopez R, Miquel I, Arias B, Sanchez P, Rincon E, Rodriguez JR, Rojas S, Murat J. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Investig. 2016 Jun;20(5):1055-63. doi: 10.1007/s00784-015-1586-1. Epub 2015 Sep 15.'}], 'seeAlsoLinks': [{'url': 'http://link.springer.com/article/10.1007%2Fs00784-015-1586-1', 'label': 'For more information about this study: Clinical Oral Investigations journal'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the bleeding time in the donor site of skin grafting.', 'detailedDescription': 'As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-113 in the donor site of sking grafting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who signed the informed consent.\n* Subjects that have to undergo a skin graft.\n* Subjects of both sexes older than 18 years.\n* Subjects that present a burn or traumatic skin injury affecting less than 30% of corporal surface.\n* Subjects with a platelet count not compatible with pathology.\n* Subjects who present haemogram results not indicative of any of the situations mentioned in the exclusion criteria.\n* Subjects who present biochemical results not indicative of any of the situations mentioned in the exclusion criteria.\n* Subjects who present coagulation parameters not indicative of any of the situations mentioned in the exclusion criteria.\n* Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.\n* Women of childbearing age who present a negative test pregnancy at the moment of study inclusion\n\nExclusion Criteria:\n\n* -Subjects with personal or family history of abnormal hemorrhagic episodes.\n* Subjects affected of any kind of congenital or acquired coagulopathies.\n* Subjects that present a burn or traumatic skin injury affecting more than 31% of corporal surface.\n* Subjects affected of any blood, heart or liver disease, chronic renal failure, severe chronic obstructive pulmonary disease, active oncologic process in the past three months, diabetes type I or who has suffered a stroke.\n* Subjects who experienced excessive bleeding after surgical procedures, childbirth or tooth extraction.\n* Subjects affected by any acute infectious disease.\n* Subjects affected of any systemic disease that may worsen the prognosis if any adverse effect occurs (decompensated type 2 diabetes mellitus, uncontrolled hypertension or severe systemic disease).\n* Subjects who should take antiplatelet therapies one week before and 48 hours after the surgery (AAS, trifusal, dipiridamol, clopidogrel, abciximab).\n* Subjects with known hypersensitivity or allergy to any component of the drug.\n* Subjects who consume abuse drugs excluding cannabis and its derivatives.\n* Subjects who are unable to follow or understand properly the instructions and requirements of the study.\n* Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.\n* Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.\n* Subjects that are the investigators, collaborators, nurses, center employees or any other person directly related to the development of the protocol.\n* Subjects who are positive to HIV or HCV serology, or who present active HBV infection.\n* Subjects who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT02012569', 'acronym': 'EHTIC', 'briefTitle': 'Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thrombotargets Europe S.L'}, 'officialTitle': 'A Phase II Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of TT-173 Applied in the Donor Site of Patients Undergoing Skin Graft', 'orgStudyIdInfo': {'id': 'THO-IM_01-CT'}, 'secondaryIdInfos': [{'id': '2013-002784-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TT.173', 'description': 'It is applied directly to the bleeding of the donor site', 'interventionNames': ['Drug: TT-173']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'It is applied directly to the bleeding of the donor site', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TT-173', 'type': 'DRUG', 'otherNames': ['topical hemostatic agent'], 'description': 'Bleeding of the lesion will be evaluated after each product application and will be recorded as bleeding vs. not bleeding. The product will be applied at 4 times for about 1 minute apart each application after skin graft obtention.', 'armGroupLabels': ['TT.173']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08860', 'city': 'Castelldefels', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Thrombotargets Europe', 'geoPoint': {'lat': 41.27794, 'lon': 1.97033}}], 'overallOfficials': [{'name': 'Santiago Rojas, Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thrombotargets Europe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thrombotargets Europe S.L', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}