Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 2:30 AM
Study NCT ID:
NCT05610267
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dennis.young@integralife.com', 'phone': '443 766 2569', 'title': 'Dr. Dennis Adam Young', 'organization': 'Integra LifeSciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months', 'description': 'Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 13, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Application site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Instillation site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal wall infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iatrogenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Volvulus of small bowel', 'notes': 'Eroded abdominal wall mesh and volvulus of small intestine adhered to the eroded mesh, surgically treatedEroded abdominal wall mesh and volvulus of small intestine adhered to the eroded mesh, surgically treated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incisional hernia', 'notes': 'Fall originated a different hernia incarcerated abdominal preperitoneal fat pad', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Postoperative adhesion', 'notes': 'Admitted in hospital, adhesions released, obstruction resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Surgical Site Infections (SSIs) Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Later Post-operative Complications After 90 Days Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a later post-operative complications after 90 days post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Hernia Recurrence Confirmed by Clinical Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a hernia recurrence confirmed by clinical assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Reoperation Requirement Due to Index Repair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a reoperation requirement due to index repair', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Number of days between the date of the index procedure and the date of the hospital discharge', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number of subjects who used opioids following the procedure based on the concomitants medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The retrospective chart review including the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and September 1, 2022 (90 days prior to the start of data collection) started in November 2022 and ended in december 2022. The enrollment occured at a single Surgical center.', 'preAssignmentDetails': '29 subjects screened, 1 subject, screened failure. 28 subjects, male and female were enrolled and completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device: Retrospective Chart Review', 'description': 'Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '12.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-11', 'size': 11615079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-24T03:25', 'hasProtocol': True}, {'date': '2022-12-22', 'size': 6479741, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-24T10:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2022-11-02', 'resultsFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-14', 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)', 'timeFrame': '90 days', 'description': 'Number of days between the date of the index procedure and the date of the hospital discharge'}, {'measure': 'Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled', 'timeFrame': '90 days', 'description': 'Number of subjects who used opioids following the procedure based on the concomitants medication'}], 'primaryOutcomes': [{'measure': 'Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure', 'timeFrame': '90 days', 'description': 'Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure'}], 'secondaryOutcomes': [{'measure': 'Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure', 'timeFrame': '90 days', 'description': 'Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure'}, {'measure': 'Incidence of Surgical Site Infections (SSIs) Post Index Procedure', 'timeFrame': '90 days', 'description': 'Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure'}, {'measure': 'Incidence of Later Post-operative Complications After 90 Days Post Index Procedure', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a later post-operative complications after 90 days post index procedure'}, {'measure': 'Incidence of Hernia Recurrence Confirmed by Clinical Assessment', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a hernia recurrence confirmed by clinical assessment'}, {'measure': 'Incidence of Reoperation Requirement Due to Index Repair', 'timeFrame': '1 year', 'description': 'Percentage of subjects with a reoperation requirement due to index repair'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.', 'detailedDescription': 'Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..\n2. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.\n\nExclusion Criteria:\n\n1. Subject has known allergy to porcine-derived products.\n2. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.\n3. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.\n4. Subject had uncontrolled diabetes, defined as Hb1AC value \\>7% within 12 weeks prior to index procedure.\n5. Subject has been diagnosed with cirrhosis and/or ascites.'}, 'identificationModule': {'nctId': 'NCT05610267', 'briefTitle': 'Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair', 'orgStudyIdInfo': {'id': 'T-GENVIH-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrospective chart review', 'type': 'DEVICE', 'description': 'The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Surgical Healing Arts Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}], 'overallOfficials': [{'name': 'Adam Young, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Integra LifeSciences Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}