Study of Hemostatic Efficacy of the HemCon Dental Dressin... | NCT00707564

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

NCT00707564

Sponsor

HemCon Medical Technologies, Inc

Status

Withdrawn

Last Update Posted

Sep 24, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Tooth Extractions

Interventions

HemCon Dental Dressing
Gauze with pressure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to enroll patient population

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 27, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2012

Last Update Posted Date

Sep 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	HemCon Dental Dressing	Device: HemCon Dental Dressing
2	Active Comparator	Gauze with pressure	Device: Gauze with pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HemCon Dental Dressing	Device	The HemCon Dental Dressing is an oral wound dressing made of chitosan	1

Measure	Description	Time Frame
Time to hemostasis		minutes after application

Measure	Description	Time Frame
Incidence of post surgical sequela		1 week post surgery

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Rodney Nichols, DMD		Milwaukie	Oregon	97222	United States
Jay P. Malmquist, DMD