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
This study has been completed.
Sponsor:
Dhanunjaya Lakkireddy, MD, FACC
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00599261
First received: January 11, 2008
Last updated: January 8, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2008 | ||||
| Last Updated Date | January 8, 2013 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00599261 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Infection | ||||
| Intervention ICMJE | Procedure: ICD/pacemaker pocket revision
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 265 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00599261 | ||||
| Other Study ID Numbers ICMJE | 10995 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute | ||||
| Study Sponsor ICMJE | Dhanunjaya Lakkireddy, MD, FACC | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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