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

September 20, 2012 updated by: HemCon Medical Technologies, Inc

A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Milwaukie, Oregon, United States, 97222
        • Rodney Nichols, DMD
      • Portland, Oregon, United States, 97221
        • Jay P. Malmquist, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
HemCon Dental Dressing
Device: HemCon Dental Dressing
The HemCon Dental Dressing is an oral wound dressing made of chitosan
Other Names:
  • HemCon Dental Dressing.
ACTIVE_COMPARATOR: 2
Gauze with pressure
Device: Gauze with pressure
Gauze with pressure
Other Names:
  • Generic brand gauze with pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis
Time Frame: minutes after application
minutes after application

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of post surgical sequela
Time Frame: 1 week post surgery
1 week post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemCon Medical Technologies, Inc

Investigators

  • Principal Investigator: Jay Malmquist, DMD, Jay P. Malmquist, DMD, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (ESTIMATE)

July 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-I-D-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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