Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-09 @ 2:35 AM
Study NCT ID:
NCT00646334
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2008-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2008-03-18', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical function score of the SF-36 questionnaire', 'timeFrame': '21 days after insertion'}], 'secondaryOutcomes': [{'measure': 'physical function score from the SF-36 questionnaire', 'timeFrame': '6 months postoperatively'}, {'measure': "patient's daily activity", 'timeFrame': '6 months postoperatively'}, {'measure': "patient's pain", 'timeFrame': '6 months postoperatively'}, {'measure': 'wound assessment', 'timeFrame': '6 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Large Pore Size Propylene Mesh', 'Incisional Hernia', 'Randomized Controlled Double-blind Study'], 'conditions': ['Incisional Hernia Repair']}, 'referencesModule': {'references': [{'pmid': '11972542', 'type': 'BACKGROUND', 'citation': 'Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. doi: 10.1046/j.1365-2168.2002.02083.x.'}, {'type': 'BACKGROUND', 'citation': 'Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)'}, {'pmid': '8681695', 'type': 'BACKGROUND', 'citation': 'Klinge U, Conze J, Limberg W, Brucker C, Ottinger AP, Schumpelick V. [Pathophysiology of the abdominal wall]. Chirurg. 1996 Mar;67(3):229-33. German.'}, {'pmid': '9082105', 'type': 'BACKGROUND', 'citation': 'Klinge U, Conze J, Klosterhalfen B, Limberg W, Obolenski B, Ottinger AP, Schumpelick V. [Changes in abdominal wall mechanics after mesh implantation. Experimental changes in mesh stability]. Langenbecks Arch Chir. 1996;381(6):323-32. doi: 10.1007/BF00191312. German.'}, {'type': 'BACKGROUND', 'citation': 'Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103'}, {'pmid': '8934114', 'type': 'BACKGROUND', 'citation': 'Beets GL, Go PM, van Mameren H. Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs. Eur J Surg. 1996 Oct;162(10):823-5.'}, {'pmid': '11922736', 'type': 'BACKGROUND', 'citation': 'Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res. 2002 Apr;103(2):208-14. doi: 10.1006/jsre.2002.6358.'}, {'type': 'BACKGROUND', 'citation': 'Benhidjeb T, Baerlehner E, Anders S. Laparoskopische Narbenhernien Reparation: Muss das Netz fuer die Intraperitoneale Onlay-Mesh-Technik besondere Eigenschaften haben?; Chir. Gastroenterol. 2003; 19(Suppl.2): 16-22'}, {'type': 'BACKGROUND', 'citation': 'Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45'}, {'type': 'BACKGROUND', 'citation': 'Rosch R, Junge K, Stumpf M, Klinge U, Schumpelick V, Klosterhalfen B; Welche Anforderungen sollte ein ideales Netz erfuellen?; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 7-11'}, {'type': 'BACKGROUND', 'citation': 'Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267'}, {'pmid': '20624273', 'type': 'BACKGROUND', 'citation': 'Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair. BMC Surg. 2010 Jul 12;10:21. doi: 10.1186/1471-2482-10-21.'}, {'pmid': '23053458', 'type': 'RESULT', 'citation': 'Rickert A, Kienle P, Kuthe A, Baumann P, Engemann R, Kuhlgatz J, von Frankenberg M, Knaebel HP, Buchler MW. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg. 2012 Dec;397(8):1225-34. doi: 10.1007/s00423-012-1009-6. Epub 2012 Oct 3.'}]}, 'descriptionModule': {'briefSummary': "Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male patients \\>=18 years\n* Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation\n* Patients wiht vertical aponeurotic incisions only\n* Incisional hernia with hernia size \\>= 3 cm\n* Patient is capable to understand and to follow the instructions\n* written informed consent\n* no mesh implantation at the same site during a previous operation\n* immune competence of patient\n\nExclusion Criteria:\n\n* Simultanous participation in an investigational drug or medical device study\n* Patients \\< 18 years old\n* Incisional Hernia withe a hernia size \\< 3 cm\n* Repair of an acute incarcerated hernia\n* Previous mesh repair at the same site\n* Patient with other than vertical aponeurotic incisions\n* Enterotomy to be performed during hernia repair at Surgery\n* Patient is on anti-coagulations-therapy\n* Patient is known or assessed to be non-compliant\n* Additional surgical treatment at the same time (e.g. cholecystectomy)\n* Immune incompetence of patient (e.g. chemotherapy)'}, 'identificationModule': {'nctId': 'NCT00646334', 'acronym': 'Optilene', 'briefTitle': 'Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair', 'orgStudyIdInfo': {'id': 'AAG-G-H-0505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Optilene® Mesh Elastic', 'interventionNames': ['Device: Mesh Implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Ultrapro® Mesh', 'interventionNames': ['Device: Mesh Implantation']}], 'interventions': [{'name': 'Mesh Implantation', 'type': 'DEVICE', 'otherNames': ['Optilene® Mesh Elastic'], 'description': 'An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.', 'armGroupLabels': ['A']}, {'name': 'Mesh Implantation', 'type': 'DEVICE', 'otherNames': ['Ultrapro® Mesh'], 'description': 'Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69121', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Krankenhaus Salem', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '63739', 'city': 'Aschaffenburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Aschaffenburg', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '30161', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Andreas Kuthe', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '37154', 'city': 'Northeim', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Albert-Schweitzer Krankenhaus', 'geoPoint': {'lat': 51.70662, 'lon': 9.99997}}], 'overallOfficials': [{'name': 'Andreas Kuthe, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRK Krankenhaus Clementinenhaus, Hannover'}, {'name': 'Rainer Engemann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Aschaffenburg, Chirurgische Klinik'}, {'name': 'Jens Kuhlgatz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim'}, {'name': 'Peter Kienle, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum Mannheim, Chirurgische Klinik'}, {'name': 'Markus Buechler, Prof.Dr.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik'}, {'name': 'Moritz von Frankenberg, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Salem, Chirurgische Abteilung, Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}