NCT01665963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 14, 2012

Last Update Submit

August 14, 2012

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • Efficacy of TopClosure(c) System

    Outside surgeon (blinded) will determine whether wound has healed

    10 days

Study Arms (2)

TopClosure(c) Treated Wound

ACTIVE COMPARATOR

Pressure Bandage using the TopClosure(C) System

Device: TopClosure(c) System

Traditional Wound Closure Treatment

ACTIVE COMPARATOR

Pressure Bandage

Device: Pressure Bandage

Interventions

TopClosure(c) SystemDEVICE
TopClosure(c) Treated Wound
Pressure BandageDEVICE
Traditional Wound Closure Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Mark Kazatsker, MD

CONTACT

972-4-6304656markk@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

IL(1)