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

This study is not yet open for participant recruitment.
Verified August 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01665963
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013