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

Not Applicable

Withdrawn

• Conditions: Tooth Extractions
• Interventions: Device: HemCon Dental Dressing; Device: Gauze with pressure

• Registration Number: NCT00707564
• Lead Sponsor: HemCon Medical Technologies, Inc

Brief 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.

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 Timeline

• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-30
• Study Start: 2008-07
• Study First Posted: 2008-07-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	HemCon Dental Dressing	HemCon Dental Dressing
2	Gauze with pressure	Gauze with pressure

Primary Outcome Measures

Name	Time	Method
Time to hemostasis	minutes after application

Secondary Outcome Measures

Name	Time	Method
Incidence of post surgical sequela	1 week post surgery

Trial Locations

Locations (2)

Rodney Nichols, DMD; 🇺🇸 Milwaukie, Oregon, United States

Jay P. Malmquist, DMD; 🇺🇸 Portland, Oregon, United States