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Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01665963
Recruitment Status : Unknown
Verified August 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment
Wounds and Injuries Device: TopClosure(c) System Device: Pressure Bandage

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: TopClosure(c) Treated Wound
Pressure Bandage using the TopClosure(C) System
Device: TopClosure(c) System
Active Comparator: Traditional Wound Closure Treatment
Pressure Bandage
Device: Pressure Bandage

Primary Outcome Measures :
  1. Efficacy of TopClosure(c) System [ Time Frame: 10 days ]
    Outside surgeon (blinded) will determine whether wound has healed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients treated with anticoagulant therapy
  • Patients treated with antiplatelet therapy

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01665963

Contact: Mark Kazatsker, MD 972-4-6304656

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Mark Kazatsker, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT01665963     History of Changes
Other Study ID Numbers: 0042-12-HYMC
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Wounds and Injuries