Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Hillel Yaffe Medical Center Identifier:
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Efficacy of TopClosure(c) System [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT01665963     History of Changes
Other Study ID Numbers: 0042-12-HYMC
Study First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: Israel: Ministry of Health processed this record on March 03, 2015