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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665963
Enrollment
40
Registered
2012-08-16
Start date
2012-09-30
Completion date
2013-09-30
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries

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.

Interventions

DEVICETopClosure(c) System
DEVICEPressure Bandage

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of TopClosure(c) System10 daysOutside surgeon (blinded) will determine whether wound has healed

Countries

Israel

Contacts

Primary ContactMark Kazatsker, MD
markk@hy.health.gov.il972-4-6304656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026