Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT01594450
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2012-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Meshes in Infected Fields: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2012-04-22', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month postoperative morbidity', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Day 45 wound infection rate', 'timeFrame': '45 days'}, {'measure': '1-year recurrent hernia rates', 'timeFrame': '1 year'}, {'measure': 'postoperative pain', 'timeFrame': 'up to 3 years'}, {'measure': 'quality of life', 'timeFrame': 'up to 3 years'}, {'measure': 'time to cure', 'timeFrame': 'up to 3 years'}, {'measure': 'need for wound reoperation due to infection or hernia recurrence', 'timeFrame': 'up to 3 years'}, {'measure': 'impact of the cross-linked mesh structure on the primary objective', 'timeFrame': '6 months'}, {'measure': 'medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.', 'timeFrame': 'up to 3 years'}, {'measure': '3 months wound infection rate', 'timeFrame': '3 months'}, {'measure': '1 year wound infection rate', 'timeFrame': '1 year'}, {'measure': '2-year recurrent hernia rates', 'timeFrame': '2 years'}, {'measure': '3-year recurrent hernia rates', 'timeFrame': '3 years'}, {'measure': 'impact of the cross-linked mesh structure on the 1-year infection rate', 'timeFrame': '1 year'}, {'measure': 'impact of the cross-linked mesh structure on the 1-year recurrence rate', 'timeFrame': '1 year'}, {'measure': 'impact of the cross-linked mesh structure on the 3-year recurrence rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incisional ventral hernia', 'infected field', 'biological mesh'], 'conditions': ['Ventral Hernia']}, 'referencesModule': {'references': [{'pmid': '23782773', 'type': 'RESULT', 'citation': 'Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyere E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.'}]}, 'descriptionModule': {'briefSummary': 'The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.', 'detailedDescription': 'Comparison between standard wound care and the use of biological meshes in infected fields'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* wound infection related to a synthetic non-absorbable mesh for at least 15 days duration\n* incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh\n* incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters\n* incisional abdominal hernias requiring a surgical procedure\n* incisional abdominal hernias amenable to repair with a single biological mesh\n* age over 18 years\n\nExclusion Criteria:\n\n* non-infected incisional abdominal hernia\n* history of biological mesh placement\n* incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)\n* incisional abdominal hernia larger than 20 x 20 cm\n* BMI ≥ 40 kg/m2\n* ASA score 4 and 5\n* immunosuppression (including steroid and cytotoxic therapy)\n* chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder\n* life expectancy under than 36 months\n* allergy to one of the biological mesh components\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01594450', 'acronym': 'SIMBIOSE', 'briefTitle': 'Biological Meshes in Infected Fields: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study', 'orgStudyIdInfo': {'id': '2011_56'}, 'secondaryIdInfos': [{'id': '2011-A00059-34', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'biological mesh', 'description': 'patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.', 'interventionNames': ['Biological: Biological mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'without biological mesh', 'description': 'patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization.', 'interventionNames': ['Procedure: without biological mesh']}], 'interventions': [{'name': 'Biological mesh', 'type': 'BIOLOGICAL', 'otherNames': ['Biologics', 'Acellular dermal matrix'], 'description': 'patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.', 'armGroupLabels': ['biological mesh']}, {'name': 'without biological mesh', 'type': 'PROCEDURE', 'otherNames': ['standard wound care'], 'description': 'patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh', 'armGroupLabels': ['without biological mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Claude Huriez Hospital, University hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Guillaume Piessen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lille University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}