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

Not Applicable

• Conditions: Wounds and Injuries
• Interventions: Device: TopClosure(c) System; Device: Pressure Bandage

• Registration Number: NCT01665963
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16
• Study Start: 2012-09
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TopClosure(c) Treated Wound	TopClosure(c) System	Pressure Bandage using the TopClosure(C) System
Traditional Wound Closure Treatment	Pressure Bandage	Pressure Bandage

Primary Outcome Measures

Name	Time	Method
Efficacy of TopClosure(c) System	10 days	Outside surgeon (blinded) will determine whether wound has healed

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel