Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT00599261
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2008-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Pacemaker, Artificial'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '25625720', 'type': 'DERIVED', 'citation': 'Lakkireddy D, Pillarisetti J, Atkins D, Biria M, Reddy M, Murray C, Bommana S, Shanberg D, Adabala N, Pimentel R, Dendi R, Emert M, Vacek J, Dawn B, Berenbom L. IMpact of pocKet rEvision on the rate of InfecTion and other CompLications in patients rEquiring pocket mAnipulation for generator replacement and/or lead replacement or revisioN (MAKE IT CLEAN): A prospective randomized study. Heart Rhythm. 2015 May;12(5):950-6. doi: 10.1016/j.hrthm.2015.01.035. Epub 2015 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.', 'detailedDescription': 'This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or greater\n2. Willingness to provide written informed consent\n3. Subjects presenting for any of the following:\n\n 1. pacemaker/ICD generator change\n 2. pacemaker/ICD lead replacement\n 3. pacemaker/ICD lead revision\n 4. pacemaker/ICD upgrades\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. Unwillingness to provide written informed consent\n3. Subjects unable to give consent\n4. Pregnant or nursing women\n5. Patients who have undergone pocket revision or manipulation less than 365 days prior\n6. Patients who have undergone pacemaker or ICD implantation less than 365 days prior'}, 'identificationModule': {'nctId': 'NCT00599261', 'briefTitle': 'MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '10995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Removal of the fibrotic pocket surrounding the generator and leads', 'interventionNames': ['Procedure: ICD/pacemaker pocket revision']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Tissue is not removed', 'interventionNames': ['Procedure: ICD/pacemaker pocket revision']}], 'interventions': [{'name': 'ICD/pacemaker pocket revision', 'type': 'PROCEDURE', 'description': 'Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Dhanunjaya Lakkireddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dhanunjaya Lakkireddy, MD, FACC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Dhanunjaya Lakkireddy, MD, FACC', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}