NCT00707564

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: HemCon Medical Technologies, Inc · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tooth Extractions

Interventions

Type	Name	Description
DEVICE	HemCon Dental Dressing	The HemCon Dental Dressing is an oral wound dressing made of chitosan
DEVICE	Gauze with pressure	Gauze with pressure

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-07-01
• Last updated: 2012-09-24

Locations

2 sites across 1 country: United States