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

This study has been withdrawn prior to enrollment.
(unable to enroll patient population)
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT00707564
First received: June 27, 2008
Last updated: September 20, 2012
Last verified: September 2012
  Purpose
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.

Condition Intervention
Tooth Extractions Device: HemCon Dental Dressing Device: Gauze with pressure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications

Resource links provided by NLM:


Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • Time to hemostasis [ Time Frame: minutes after application ]

Secondary Outcome Measures:
  • Incidence of post surgical sequela [ Time Frame: 1 week post surgery ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HemCon Dental Dressing
Device: HemCon Dental Dressing
The HemCon Dental Dressing is an oral wound dressing made of chitosan
Other Name: HemCon Dental Dressing.
Active Comparator: 2
Gauze with pressure
Device: Gauze with pressure
Gauze with pressure
Other Name: Generic brand gauze with pressure.

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.
  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707564

Locations
United States, Oregon
Rodney Nichols, DMD
Milwaukie, Oregon, United States, 97222
Jay P. Malmquist, DMD
Portland, Oregon, United States, 97221
Sponsors and Collaborators
HemCon Medical Technologies, Inc
Investigators
Principal Investigator: Jay Malmquist, DMD Jay P. Malmquist, DMD, PC
  More Information

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT00707564     History of Changes
Other Study ID Numbers: 2007-I-D-2
Study First Received: June 27, 2008
Last Updated: September 20, 2012

Keywords provided by HemCon Medical Technologies, Inc:
hemostasis
tooth extractions

Additional relevant MeSH terms:
Anticoagulants
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 21, 2017