NCT00707564WithdrawnNot Applicable
A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
HemCon Medical Technologies, Inc4 sites in 1 countryStarted: July 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Time to hemostasis
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to hemostasis
Time Frame: minutes after application
Secondary Outcomes
- Incidence of post surgical sequela(1 week post surgery)
Investigators
Study Sites (4)
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