Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-19 @ 7:56 PM
Study NCT ID:
NCT04416412
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICG Fluorescence Imaging in Open Fracture Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005597', 'term': 'Fractures, Open'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who undergo an unplanned fracture-related reoperation', 'timeFrame': '12 months', 'description': 'All unplanned reoperations will be documented using a specific case report form'}, {'measure': 'Number of participants who experience a post-procedure surgical site infection', 'timeFrame': '12 months', 'description': 'Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunofluorescence', 'Orthopaedic', 'Trauma', 'Open Fracture'], 'conditions': ['Trauma Injury']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.', 'detailedDescription': 'This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years of age or older who present with an open fracture will be considered for the open fracture cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 18 years of age or older.\n2. Open extremity fracture.\n3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.\n4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.\n5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.\n6. Provision of informed consent.\n\nExclusion Criteria:\n\n1. Inability of patient to provide informed consent\n2. Fracture of the hand.\n3. Iodine allergy.\n4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.\n5. Open fracture managed outside of the participating orthopaedic service.\n6. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.\n7. Burns at the fracture site.'}, 'identificationModule': {'nctId': 'NCT04416412', 'briefTitle': 'ICG Fluorescence Imaging in Open Fracture Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging', 'orgStudyIdInfo': {'id': 'D20058'}, 'secondaryIdInfos': [{'id': 'OR190062', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open Fracture Cohort', 'description': 'Patients 18 years of age or older. Open extremity fracture. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.\n\nOpen fracture wound management that includes formal surgical debridement within 72 hours of their injury.\n\nWill have all planned fracture care surgeries performed by a participating surgeon or delegate.\n\nProvision of informed consent.', 'interventionNames': ['Other: Immunofluorescence Imaging']}], 'interventions': [{'name': 'Immunofluorescence Imaging', 'type': 'OTHER', 'description': 'Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.', 'armGroupLabels': ['Open Fracture Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore R. Cowley Shock Trauma', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '021115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Ida L Gitajn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dartmouth College', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'University of California, Irvine', 'class': 'OTHER'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Ida Leah Gitajn', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}