Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 2:58 PM
Study NCT ID:
NCT01901068
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2013-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MonoMax for Abdominal Wall Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2013-07-05', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of reoperation due to burst abdomen', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 days'}, {'measure': 'Frequency of wound infections', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of wound healing until day of discharge', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 days'}, {'measure': 'Length of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparotomy', 'Surgical Procedures, Elective', 'Sutures', 'Abdominal Wound Closure Techniques'], 'conditions': ['Abdominal Wall Wound']}, 'referencesModule': {'references': [{'pmid': '24281948', 'type': 'BACKGROUND', 'citation': 'Fink C, Baumann P, Wente MN, Knebel P, Bruckner T, Ulrich A, Werner J, Buchler MW, Diener MK. Incisional hernia rate 3 years after midline laparotomy. Br J Surg. 2014 Jan;101(2):51-4. doi: 10.1002/bjs.9364. Epub 2013 Nov 26.'}, {'pmid': '18644124', 'type': 'BACKGROUND', 'citation': 'Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg. 2008 Jul 21;8:12. doi: 10.1186/1471-2482-8-12.'}, {'pmid': '22183105', 'type': 'BACKGROUND', 'citation': 'Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar;397(3):363-71. doi: 10.1007/s00423-011-0884-6. Epub 2011 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Elective primary laparotomy\n* Written informed consent\n\nExclusion Criteria:\n\n* Peritonitis\n* Emergency surgery\n* Severe psychiatric and neurologic disease\n* Drug- and / or alcohol abuse according to local standard\n* Lack of informed consent\n* Current immunosuppressive therapy\n* Chemotherapy within the 2 weeks before operation\n* Radiotherapy of the abdomen completed less than 8 before surgery\n* Pregnant or breast-feeding women\n* Coagulopathy'}, 'identificationModule': {'nctId': 'NCT01901068', 'acronym': 'MULTIMAC', 'briefTitle': 'MonoMax for Abdominal Wall Closure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure', 'orgStudyIdInfo': {'id': 'AAG-O-H-1010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MonoMax', 'description': 'Elective primary laparotomy', 'interventionNames': ['Device: MonoMax']}], 'interventions': [{'name': 'MonoMax', 'type': 'DEVICE', 'description': 'Abdominal wall will be closed with MonoMax after an elective primary laparotomy.', 'armGroupLabels': ['MonoMax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Chirurgicka klinika, Fakultni nemocnine', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '77520', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Chirurgicka klinika, Fakultni nemocnine', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Central Emergency Military Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}