Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-28 @ 9:19 PM
Study NCT ID:
NCT06129669
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2023-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICG Indocyanine Green in Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum perfusion intensity (Normal)', 'timeFrame': 'Once during the surgery', 'description': '1\\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame'}, {'measure': 'Maximum perfusion intensity (ROI)', 'timeFrame': 'Once during the surgery', 'description': '2\\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame'}, {'measure': 'Relative Perfusion', 'timeFrame': 'Once during the surgery', 'description': 'Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame / Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'Once during the surgery', 'description': 'Time to reach maximum perfusion in region of interest (Tmax, sec)'}, {'measure': 'Ingress', 'timeFrame': 'Once during the surgery', 'description': 'Rate of increase in intensity from baseline to peak intensity (Ingress, units)'}, {'measure': 'Egress', 'timeFrame': 'Once during the surgery', 'description': 'Degree of decrease in intensity from peak to last measurement (Egress, units)'}, {'measure': 'Lap Failure', 'timeFrame': 'Follow up at six weeks postoperative', 'description': 'Quantified as I \\<5%; II 5-15%, III 15-50%, IV\\> 50%, V complete'}, {'measure': 'Wound infection', 'timeFrame': 'Follow up at six weeks postoperative', 'description': 'Defined as none, local wound treatment, antibiotics, or hospitalization.'}, {'measure': 'Skin necrosis', 'timeFrame': 'Follow up at six weeks postoperative', 'description': 'Defined as none, partial thickness, and full thickness.'}, {'measure': 'Delayed union', 'timeFrame': 'Follow up at six and twelve months postoperative', 'description': 'Radiologic examination (Xray or CT) concluding on the presence of delayed union after 6 months or non-union after 12 months'}, {'measure': 'Relative Perfusion before and after tissue transfer', 'timeFrame': 'Twice during the surgery', 'description': 'Maximum perfusion intensity (Imax, units) in the same reference frame after tissue transfer / Maximum perfusion intensity (Imax, units) in a reference frame before tissue transfer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reconstructive surgery', 'Free flap', 'Pedicled flap', 'Debridement', 'Fluorescence imaging', 'Indocyanine green'], 'conditions': ['Surgery', 'Fluorescence']}, 'referencesModule': {'references': [{'pmid': '40387116', 'type': 'DERIVED', 'citation': "Van 't Hof LWP, Koster ITS, Van den Elzen RM, Bouman MB, Botman M, Driessen C. Quantitative Perfusion Assessment Using Indocyanine Green in Lower Extremity Perforator Flaps. Surg Innov. 2025 Oct;32(5):435-441. doi: 10.1177/15533506251339929. Epub 2025 May 19."}]}, 'descriptionModule': {'briefSummary': 'The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We include patients that undergo a surgical debridement and/or reconstruction. Each group consists of twenty patients.\n\nThe debridement groups mainly consist of post-oncologic patients who have undergone radiotherapy (1A) and trauma patients (1B).\n\nReconstructive groups include 2A Fasciocutaneous flaps 2B Osseous flaps 2C Muscle flaps 2D Vaginaplasties 2E Phalloplasties 2F Finger replantations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 or older\n* Undergoing debridement and/or reconstructive surgery included in the aforementioned groups\n\nExclusion Criteria:\n\n* allergy or hypersensitivity to sodium iodide, iodine, ICG or shellfish\n* patients with hyperthyroidism and patients with autonomic thyroid adenoma\n* pregnancy or lactation\n* epilepsy\n* severe liver failure\n* renal failure with a GFR \\<60.'}, 'identificationModule': {'nctId': 'NCT06129669', 'acronym': 'ICG-R', 'briefTitle': 'ICG Indocyanine Green in Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery', 'orgStudyIdInfo': {'id': 'NL74852.029.21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Debridement after radiotherapy', 'description': 'Debridement after radiotherapy', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Debridement after trauma', 'description': 'Debridement after trauma', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Reconstructive surgery using a fasciocutaneous flap', 'description': 'Reconstructive surgery using a fasciocutaneous flap', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Reconstructive surgery using a muscle flap', 'description': 'Reconstructive surgery using a muscle flap', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Reconstructive surgery using a osseous flap', 'description': 'Reconstructive surgery using a osseous flap', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Vaginaplasties', 'description': 'Vaginaplasties using a peritoneum flap or colon interposition', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Phalloplasties', 'description': 'Phalloplasties', 'interventionNames': ['Drug: Indocyanine green']}, {'label': 'Finger replantation', 'description': 'Finger replantation', 'interventionNames': ['Drug: Indocyanine green']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'DRUG', 'description': 'Administration of ICG during surgery and recording of the fluorescence video to perform data analyses', 'armGroupLabels': ['Debridement after radiotherapy', 'Debridement after trauma', 'Finger replantation', 'Phalloplasties', 'Reconstructive surgery using a fasciocutaneous flap', 'Reconstructive surgery using a muscle flap', 'Reconstructive surgery using a osseous flap', 'Vaginaplasties']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Caroline Driessen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Plastic Surgeon', 'investigatorFullName': 'Caroline Driessen', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}