Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds
Primary Purpose
Wounds and Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TopClosure(c) System
Pressure Bandage
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
Eligibility Criteria
Inclusion Criteria:
- Patients treated with anticoagulant therapy
- Patients treated with antiplatelet therapy
Exclusion Criteria:
- None
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TopClosure(c) Treated Wound
Traditional Wound Closure Treatment
Arm Description
Pressure Bandage using the TopClosure(C) System
Pressure Bandage
Outcomes
Primary Outcome Measures
Efficacy of TopClosure(c) System
Outside surgeon (blinded) will determine whether wound has healed
Secondary Outcome Measures
Full Information
NCT ID
NCT01665963
First Posted
August 14, 2012
Last Updated
August 14, 2012
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01665963
Brief Title
Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of hematoma after device implantation. This study intends to examine the efficacy of the TopClosure(c) System in wound healing in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TopClosure(c) Treated Wound
Arm Type
Active Comparator
Arm Description
Pressure Bandage using the TopClosure(C) System
Arm Title
Traditional Wound Closure Treatment
Arm Type
Active Comparator
Arm Description
Pressure Bandage
Intervention Type
Device
Intervention Name(s)
TopClosure(c) System
Intervention Type
Device
Intervention Name(s)
Pressure Bandage
Primary Outcome Measure Information:
Title
Efficacy of TopClosure(c) System
Description
Outside surgeon (blinded) will determine whether wound has healed
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated with anticoagulant therapy
Patients treated with antiplatelet therapy
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Kazatsker, MD
Phone
972-4-6304656
Email
markk@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Kazatsker, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds
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