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

This study is currently recruiting participants.

Verified by HemCon Medical Technologies, Inc, June 2008

Sponsored by:	HemCon Medical Technologies, Inc
Information provided by:	HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:	NCT00707564

Purpose

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.

Condition	Intervention
Tooth Extractions	Device: Hemcon Dental Dressing Device: Gauze with pressure

MedlinePlus related topics: Blood Thinners

Drug Information available for: Chitosan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the Hemcon Dental Dressing in a Population Treated With Anticoagulant Medications

Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:

Time to hemostasis [ Time Frame: minutes after application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of post surgical sequela [ Time Frame: 1 week post surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	38
Study Start Date:	July 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hemcon Dental Dressing	Device: Hemcon Dental Dressing The Hemcon Dental Dressing is an oral wound dressing made of chitosan
2: Active Comparator Gauze with pressure	Device: Gauze with pressure Gauze with pressure

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707564

Contacts

Contact: Sharon Wilson

503 292 8824

Sharon@drjaypmalmquist.com

Locations

United States, Oregon
Jay P. Malmquist, DMD	Recruiting
Portland, Oregon, United States, 97221
Sub-Investigator: Stephen Clemens, DMD
Rodney Nichols, DMD	Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Rodney Nichols, DMD 503-654-3530
Principal Investigator: Rodney Nichols, DMD

Sponsors and Collaborators

HemCon Medical Technologies, Inc

Investigators

Principal Investigator:

Jay Malmquist, DMD

Jay P. Malmquist, DMD, PC

More Information

Responsible Party:	Hemcon Medical Technologies, Inc ( Leslie North, Vice President Clinical Trials )
Study ID Numbers:	2007-I-D-2
Study First Received:	June 27, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00707564
Health Authority:	United States: Food and Drug Administration

Keywords provided by HemCon Medical Technologies, Inc:

hemostasis, tooth extractions

Study placed in the following topic categories:

Chitosan

ClinicalTrials.gov processed this record on January 16, 2009