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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT00707486
First received: June 27, 2008
Last updated: December 6, 2012
Last verified: December 2012
Results First Received: April 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tooth Extractions
Interventions: Device: Hemcon Dental Dressing
Device: Gauze with Pressure and/or Gelfoam

  Participant Flow
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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
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Reporting Groups
  Description
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  
STARTED     72  
COMPLETED     71  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  72  
Age  
[units: participants]
 
<=18 years     30  
Between 18 and 65 years     42  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.1  ± 3.95  
Gender  
[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
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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
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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
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  More Information
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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
e-mail: staci@hemcon.com


No publications provided


Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT00707486     History of Changes
Other Study ID Numbers: 2007-I-D-1
Study First Received: June 27, 2008
Results First Received: April 2, 2010
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration