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NCT01665963 Clinical Trial

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

Wounds and Injuries Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01665963
Other study ID # 0042-12-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 14, 2012
Last updated August 14, 2012
Start date September 2012
Est. completion date September 2013

Study information
Verified date August 2012
Source Hillel Yaffe Medical Center
Contact Mark Kazatsker, MD
Phone 972-4-6304656
Email markk@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients treated with anticoagulant therapy

- Patients treated with antiplatelet therapy

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• TopClosure(c) System

• Pressure Bandage

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of TopClosure(c) System Outside surgeon (blinded) will determine whether wound has healed 10 days No
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