Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT01136603
Status:
UNKNOWN
Last Update Posted:
2014-01-28
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shrinkage profiles of the implant', 'timeFrame': '1 year', 'description': 'Assess the shrinkage profiles of the implant after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'Amount of tissue ingrowth', 'timeFrame': '1 year', 'description': 'Assess the amount of tissue ingrowth after implantation using Ultrasound at 1 week, 1 month, 3 months, 6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal wall defects', 'Inflammation reactions', 'Amount of tissue ingrowth', 'Adhesion formation', 'Shrinkage profiles of the implant'], 'conditions': ['Hernia']}, 'descriptionModule': {'briefSummary': 'Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep inferior epigastric perforator (DIEP) flap.', 'detailedDescription': 'In this study we will be conducting a randomized trial to study the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap.\n\nAims -\n\n1. Investigating the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap. Efficacy of TIGR will allow us to determine the stability of the material in the abdominal wall reconstruction.\n2. Study the absorption characteristics of TIGR implant as compared with a non absorbable polypropylene mesh. Absorption characteristics can be determined by the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant and it can be detect using ultrasound.\n3. To determine whether any reactions to the implant will occur. These reaction if any will manifest as inflammation reactions which may be evident on clinical followup and can be detect by ultrasound.\n\nPatients to be recruited :\n\n80 randomized equally into the 2 groups Age range: 21 - 80 All patients undergoing lipectomy, TRAM / DIEP flap reconstruction will be recruited into the study.\n\nTrial Duration: July 2010 - July 2015\n\nFollow up:\n\nPostoperative 1 week, 1 month, 3 months, 6 months, and 12 months Ultrasound will be done to determine the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant in all these follow up appointments. Complications if any can also be detected by the Ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 - 80 years\n* Both Male, Female\n* all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction\n* patients with abdominal wall defects\n\nExclusion Criteria:\n\n* patient refusal\n* infection of the abdominal / generalised infection'}, 'identificationModule': {'nctId': 'NCT01136603', 'briefTitle': 'TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.', 'orgStudyIdInfo': {'id': 'NUHS/SUR-PRAS/2010/2'}, 'secondaryIdInfos': [{'id': 'D / 10 / 344', 'type': 'REGISTRY', 'domain': 'DSRB: D/ 10 / 344'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIGR Mesh', 'description': 'Experimental - TIGR Mesh', 'interventionNames': ['Device: TIGR Mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group - Non absorbable Polypropylene mesh', 'interventionNames': ['Device: TIGR Mesh']}], 'interventions': [{'name': 'TIGR Mesh', 'type': 'DEVICE', 'otherNames': ['Experimental - TIGR Matrix Surgical Mesh', 'Control - Polypropylene mesh'], 'description': 'TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.', 'armGroupLabels': ['Control', 'TIGR Mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Thiam Chye Lim, FRCS', 'role': 'CONTACT', 'email': 'surlimtc@nus.edu.sg', 'phone': '67722022'}, {'name': 'Eileen Hing', 'role': 'CONTACT', 'email': 'surhch@nus.edu.sg', 'phone': '67722276'}], 'facility': 'National University Hospital, Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Thiam Chye Lim, MD', 'role': 'CONTACT', 'email': 'surlimtc@nus.edu.sg', 'phone': '67722022'}, {'name': 'Eileen Hing', 'role': 'CONTACT', 'email': 'surhch@nus.edu.sg', 'phone': '67722276'}], 'overallOfficials': [{'name': 'Thiam Chye Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'LIM THIAM CHYE / Professor', 'oldOrganization': 'National University Hospital / National Unviersity of Singapore'}}}}