Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT01869257
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2013-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '30 days'}], 'primaryOutcomes': [{'measure': 'Rate of surgical site infection', 'timeFrame': '30 days', 'description': 'the incidence of superficial and deep wound infection in patients who underwent colorectal resection will be determined by a blind observer according to the Atlanta CDC definition.\n\nThe unit of measure will be number of wound infection over the number of treated or control patients'}], 'secondaryOutcomes': [{'measure': 'overall wound complications', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['triclosan', 'colorectal', 'surgery', 'surgical site infection'], 'conditions': ['Colorectal Resection']}, 'referencesModule': {'references': [{'pmid': '22470067', 'type': 'BACKGROUND', 'citation': 'Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials. Ann Surg. 2012 May;255(5):854-9. doi: 10.1097/SLA.0b013e31824e7005.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful.\n\nThe primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.', 'detailedDescription': 'This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind study. Two hundred and seventy-three patients candidate to colorectal resection were enrolled. Exclusion criteria were: age \\< 18 or \\> 85 years, pregnancy, peritonitis, peritoneal contamination during operation, ongoing infections, ASA score \\> 3, denied consent.\n\n135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by office visits for 30 days after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients candidate to elective colorectal resection\n\nExclusion Criteria:\n\n* no consent\n* peritonitis\n* hypersensitivity to triclosan\n* ASA \\> 3\n* ongoing infections'}, 'identificationModule': {'nctId': 'NCT01869257', 'briefTitle': 'Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery', 'orgStudyIdInfo': {'id': 'CR-SSI 09'}, 'secondaryIdInfos': [{'id': 'UNIMIB18', 'type': 'OTHER', 'domain': 'Milano-Bicocca University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'regular suture not coated with triclosan', 'interventionNames': ['Device: regular suture']}, {'type': 'EXPERIMENTAL', 'label': 'triclosan', 'description': 'Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan', 'interventionNames': ['Device: Triclosan coated suture']}], 'interventions': [{'name': 'Triclosan coated suture', 'type': 'DEVICE', 'description': 'The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture', 'armGroupLabels': ['triclosan']}, {'name': 'regular suture', 'type': 'DEVICE', 'description': 'The control arm will have the abdominal wound sutured with a regular non-coated suture', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'San Gerardo Hospital', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Angelo Nespoli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Milano-Bicocca University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Luca Vittorio Gianotti', 'investigatorAffiliation': 'University of Milano Bicocca'}}}}