Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:58 AM
Study NCT ID:
NCT00762060
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2008-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Infection Surveillance Study Following Colorectal Procedures
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2008-09-29', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days postoperative'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'Average 1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal surgery'], 'conditions': ['Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.', 'detailedDescription': 'This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical patients Colorectal procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, \\>18 years of age;\n* Scheduled for elective colon procedure;\n* Ability to complete patient survey questionnaires;\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);\n* Procedures for hemorrhoids;\n* Inability to perform follow up assessments'}, 'identificationModule': {'nctId': 'NCT00762060', 'acronym': 'MISS', 'briefTitle': 'Multicenter Infection Surveillance Study Following Colorectal Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halyard Health'}, 'officialTitle': 'Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures', 'orgStudyIdInfo': {'id': 'MISScolorectal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active', 'description': 'Surgical site continuous local anesthetic infusion with ONQ silver Soaker System', 'interventionNames': ['Device: ON-Q Silver soaker System']}, {'label': 'Control', 'description': 'Hospital standard of care for pain management (Patient controlled analgesia or epidural)', 'interventionNames': ['Drug: Patient controlled analgesia']}], 'interventions': [{'name': 'ON-Q Silver soaker System', 'type': 'DEVICE', 'otherNames': ['Continuous surgical site local anesthetic infusion'], 'description': 'Continuous infusion of local anesthetic to surgical site', 'armGroupLabels': ['Active']}, {'name': 'Patient controlled analgesia', 'type': 'DRUG', 'otherNames': ['PCA'], 'description': 'IV opioids delivered via PCA', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jay Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piedmont Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halyard Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}