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

Tooth Extractions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00707564
• Other study ID #: 2007-I-D-2
• Status: Withdrawn
• Phase: N/A
• First received: June 27, 2008
• Last updated: September 20, 2012
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2012
• Source: HemCon Medical Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Extractions

Intervention

Device:
• HemCon Dental Dressing
The HemCon Dental Dressing is an oral wound dressing made of chitosan
• Gauze with pressure
Gauze with pressure

Locations

Country	Name	City	State
United States	Rodney Nichols, DMD	Milwaukie	Oregon
United States	Jay P. Malmquist, DMD	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
HemCon Medical Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis		minutes after application	No
Secondary	Incidence of post surgical sequela		1 week post surgery	Yes