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Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications

NCT ID: NCT00707564

Last Updated: 2012-09-24

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.

Detailed Description

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As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.

Conditions

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Tooth Extractions

Keywords

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hemostasis tooth extractions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HemCon Dental Dressing

Group Type EXPERIMENTAL

HemCon Dental Dressing

Intervention Type DEVICE

The HemCon Dental Dressing is an oral wound dressing made of chitosan

2

Gauze with pressure

Group Type ACTIVE_COMPARATOR

Gauze with pressure

Intervention Type DEVICE

Gauze with pressure

Interventions

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HemCon Dental Dressing

The HemCon Dental Dressing is an oral wound dressing made of chitosan

Intervention Type DEVICE

Gauze with pressure

Gauze with pressure

Intervention Type DEVICE

Other Intervention Names

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HemCon Dental Dressing. Generic brand gauze with pressure.

Eligibility Criteria

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Inclusion Criteria

* Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
* Patients requiring a minimum of 2 tooth extraction procedures.
* Index pairing must reflect anatomically similar extraction locations
* 14 years of age or older
* Available for a minimum of one post operative evaluation approximately 7 days post surgery
* Extraction sites do not require primary closure or suturing
* Willingness and ability to provide informed consent/ assent

Exclusion Criteria

* Scheduled to undergo a procedure other than tooth extractions
* In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
* Scheduled to undergo 2 extractions, anatomically dissimilar
* Extraction procedures are expected to require primary closure or suture
* Unwilling or unable to provide informed consent/ assent
* Patients undergoing bisphosphonate therapy
* Patients not under current treatment with an oral anticoagulant medication
* Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemCon Medical Technologies, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Malmquist, DMD

Role: PRINCIPAL_INVESTIGATOR

Jay P. Malmquist, DMD, PC

Locations

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Rodney Nichols, DMD

Milwaukie, Oregon, United States

Site Status

Jay P. Malmquist, DMD

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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2007-I-D-2

Identifier Type: -

Identifier Source: org_study_id