Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-28 @ 4:04 PM
Study NCT ID:
NCT00932503
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2009-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiseptic Sutures and Wound Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 839}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2009-07-01', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was the number of wound infections.', 'timeFrame': '10 days after demission of patient from hospital'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome was the number of incisional hernia', 'timeFrame': 'follow up points: 6 month, 1 year, 2 years and 3 years', 'description': 'long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vicryl plus', 'wound infection', 'coated suture material', 'open abdominal surgery', 'transverse laparotomy'], 'conditions': ['Wound Infection']}, 'referencesModule': {'references': [{'pmid': '19231586', 'type': 'RESULT', 'citation': 'Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibacterial [corrected] coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. doi: 10.1016/j.surg.2008.11.007. Epub 2009 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.', 'detailedDescription': 'All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.\n\nWound closure is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgical pathologies accessed via transverse abdominal incision\n* primary fascial closure\n\nExclusion Criteria:\n\n* pregnancy\n* age under 18 years\n* open abdominal treatment\n* known hypersensitivity agains PDS/Vicryl/Triclosan'}, 'identificationModule': {'nctId': 'NCT00932503', 'briefTitle': 'Antiseptic Sutures and Wound Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.', 'orgStudyIdInfo': {'id': 'Vicryl plus 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'PDS II', 'description': 'PDS II® loop suture was used for abdominal wall closure'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vicryl plus', 'description': 'antiseptic coated "Vicryl plus" was used for abdominal wall closure', 'interventionNames': ['Device: Vicryl plus']}], 'interventions': [{'name': 'Vicryl plus', 'type': 'DEVICE', 'otherNames': ['Vicryl plus®'], 'description': 'triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)', 'armGroupLabels': ['Vicryl plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany'}], 'overallOfficials': [{'name': 'Christoph Justinger, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany'}, {'name': 'Martin K Schilling, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery', 'investigatorFullName': 'Christoph Justinger', 'investigatorAffiliation': 'University Hospital, Saarland'}}}}