A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707486
Recruitment Status : Completed
First Posted : July 1, 2008
Results First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tooth Extractions
Interventions: Device: Hemcon Dental Dressing
Device: Gauze with Pressure and/or Gelfoam

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited as they presented at the site of the study for extraction. Subjects served as their own control as they had four extractions per procedure and two served as the experimental sites and two served as the control sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Hemcon Dental Dressing With Pressure Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.

Participant Flow:   Overall Study
    Hemcon Dental Dressing With Pressure
Withdrawal by Subject                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Hemcon Dental Dressing and Gauze With Pressure In the case of this study, participants served as their own control.

Baseline Measures
   Hemcon Dental Dressing and Gauze With Pressure 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   30 
Between 18 and 65 years   42 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 19.1  (3.95) 
[Units: Participants]
Female   34 
Male   38 
Region of Enrollment 
[Units: Participants]
United States   72 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 73.3  (8.36) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 128.1  (15.13) 

  Outcome Measures

1.  Primary:   Time to Hemostasis   [ Time Frame: Minutes After Application ]

2.  Secondary:   Incidence of Post Surgical Sequelae   [ Time Frame: 1 week post surgery ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Staci McAdams
Organization: HemCon Medical Technologies
phone: (503)245-0459 ext 103

Responsible Party: HemCon Medical Technologies, Inc Identifier: NCT00707486     History of Changes
Other Study ID Numbers: 2007-I-D-1
First Submitted: June 27, 2008
First Posted: July 1, 2008
Results First Submitted: April 2, 2010
Results First Posted: January 9, 2013
Last Update Posted: January 9, 2013