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

NCT00707564 | Withdrawn

• 1 other identifier: 2007-I-D-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Tooth Extractions

Keywords

hemostasis; tooth extractions

Outcome Measures

Primary Outcomes (1)

• Time to hemostasis

  minutes after application

Secondary Outcomes (1)

• Incidence of post surgical sequela

  1 week post surgery

Study Arms (2)

1

EXPERIMENTAL

HemCon Dental Dressing

Device: HemCon Dental Dressing

2

ACTIVE COMPARATOR

Gauze with pressure

Device: Gauze with pressure

Interventions

HemCon Dental Dressing DEVICE

The HemCon Dental Dressing is an oral wound dressing made of chitosan

Also known as: HemCon Dental Dressing.

1

Gauze with pressure DEVICE

Gauze with pressure

Also known as: Generic brand gauze with pressure.

2

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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
• 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 qualify 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

Sponsors & Collaborators

• HemCon Medical Technologies, Inc: lead

Study Sites (2)

Rodney Nichols, DMD

Milwaukie, Oregon, 97222, United States

Location

Jay P. Malmquist, DMD

Portland, Oregon, 97221, United States

Location

Study Officials

• Jay Malmquist, DMD

  Jay P. Malmquist, DMD, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (2)