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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Wounds and Injuries

Treatments: Device: TopClosure(c) System; Device: Pressure Bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT01665963

0042-12-HYMC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

TopClosure(c) Treated Wound

Active Comparator group

Description:

Pressure Bandage using the TopClosure(C) System

Treatment:

Device: TopClosure(c) System

Traditional Wound Closure Treatment

Active Comparator group

Description:

Pressure Bandage

Treatment:

Device: Pressure Bandage