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

Study Overview
=================
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.

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

Conditions
-----------------
Tooth Extractions

Intervention / Treatment
-----------------
* Device: HemCon Dental Dressing
* Device: Gauze with pressure


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HemCon Dental Dressing | Device: HemCon Dental Dressing<br>* The HemCon Dental Dressing is an oral wound dressing made of chitosan<br>* Other names: HemCon Dental Dressing.;|
| Active Comparator: 2<br>Gauze with pressure | Device: Gauze with pressure<br>* Gauze with pressure<br>* Other names: Generic brand gauze with pressure.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post surgical sequela |  | 1 week post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemostasis, tooth extractions