Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT02466594
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2015-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Active Thermoregulation on the Microcirculation of Free Flaps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-05', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Flow (AU) measured by Doppler flowmetry and remission spectroscopy (Oxygen to See, O2C®, Lea Medizintechnik, Giessen, Germany)', 'timeFrame': 'Measurements were conducted at the day of the operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Microcirculation', 'Thermoregulation', 'Free Flap']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of active thermoregulation on free flap microcirculation following free flap transfer. Thermoregulation is performed by passive warming, active warming (water circulation based device) and active cooling. Changes in microcirculation are assessed using combined laser Doppler flowmetry and remission spectroscopy.', 'detailedDescription': 'Measurements are conducted at the day of the operation as well as the first three days following the operation. Tissue temperature is assessed by a temperature measurement probe that is placed 8 mm underneath the skin. The microcirculation parameters of free perforator flaps are assessed using combined laser Doppler flowmetry and remission spectroscopy (O2C®). This allows non-invasive measurement of blood flow, capillary venous oxygen saturation and relative postcapillary filling pressure using a fiber optic probe that is placed on the flap surface. Controlled Thermoregulation (between 10 and 38°C) is enabled using a water circulation based system (Hilotherm Clinic®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients receiving free perforator flaps with a skin island not less than 4x4 cm\n\nExclusion Criteria:\n\n* non-compliance,\n* non-consent,\n* history of cardiac disease,\n* arterial hypo- or hypertension,\n* intake of vasoactive drugs,\n* peripheral arterial occlusive disease,\n* chronic kidney and liver disease,\n* vasculitis'}, 'identificationModule': {'nctId': 'NCT02466594', 'briefTitle': 'Impact of Active Thermoregulation on the Microcirculation of Free Flaps', 'organization': {'class': 'OTHER', 'fullName': 'Klinik Bogenhausen'}, 'officialTitle': 'Impact of Active Thermoregulation on the Microcirculation of Free Flaps', 'orgStudyIdInfo': {'id': 'KBogenhausen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hilotherm Clinic®', 'description': 'Intervention: Controlled Thermoregulation with Hilotherm Clinic® - Flap Temperature is altered by passive warming (dressing), active warming (38 C) and active cooling (10 C) each for 60 minutes following free flap transfer in every subject at the day of surgery and the following three days', 'interventionNames': ['Device: Hilotherm Clinic®']}], 'interventions': [{'name': 'Hilotherm Clinic®', 'type': 'DEVICE', 'description': 'Controlled Thermoregulation using a water circulation based system (Hilotherm Clinic®). Controlled Thermoregulation with Hilotherm Clinic® - Flap Temperature is altered by passive warming (dressing), active warming (38 C) and active cooling (10 C) each for 60 minutes following free flap transfer in every subject at the day of surgery and the following three days', 'armGroupLabels': ['Hilotherm Clinic®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81925', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Ulf Dornseifer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulf Dornseifer, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Ulf Dornseifer, MD', 'investigatorAffiliation': 'Klinik Bogenhausen'}}}}