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

NCT ID: NCT01665963

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Wounds and Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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TopClosure(c) Treated Wound

Pressure Bandage using the TopClosure(C) System

Group Type ACTIVE_COMPARATOR

TopClosure(c) System

Intervention Type DEVICE

Traditional Wound Closure Treatment

Pressure Bandage

Group Type ACTIVE_COMPARATOR

Pressure Bandage

Intervention Type DEVICE

Interventions

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TopClosure(c) System

Intervention Type DEVICE

Pressure Bandage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients treated with anticoagulant therapy
* Patients treated with antiplatelet therapy

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Mark Kazatsker, MD

Role: CONTACT

Phone: 972-4-6304656

Email: [email protected]

Other Identifiers

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0042-12-HYMC

Identifier Type: -

Identifier Source: org_study_id