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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665963
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
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.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
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 Intervention
Wounds and Injuries Device: TopClosure(c) System Device: Pressure Bandage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

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


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01665963


Contacts
Contact: Mark Kazatsker, MD 972-4-6304656 markk@hy.health.gov.il

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

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01665963     History of Changes
Other Study ID Numbers: 0042-12-HYMC
First Submitted: August 14, 2012
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Wounds and Injuries