Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
HemCon Medical Technologies, Inc
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.
Age
14–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
