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Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis

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: NCT00863356
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc

Brief Summary:


This study is a prospective clinical trial to investigate the efficacy of a chitosan-coated nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management of difficult spontaneous epistaxis and to evaluate its healing effect on nasal mucosa.

The introduction of products that enhances hemostasis can have clinical advantages when associated with traditional nasal packing. These advantages include a better hemostatic control and the reduction of nasal packing duration. Furthermore, this study will help determine if there are any non-desirable effects that chitosan may have on the nasal cavity, such as the production of fibrosis and foreign body reaction.

Condition or disease Intervention/treatment Phase
Epistaxis Device: 2009-I-Epistaxis-1 Not Applicable

Detailed Description:

Epistaxis is a common reason for emergency department visits and otolaryngology referral. Management methods of epistaxis include nasal packing, chemical or electric cauterization, and arterial ligation or embolization.

There are numerous nasal packing products available in the market, and are used to stop or prevent nasal bleeding. The ideal nasal pack should be efficient in controlling bleeding, have antimicrobial properties and be well tolerated. Currently, there is no perfect nasal pack, but some are closer to ideal than others. Nasal packs can be classified into non-absorbable and absorbable nasal packs.

Recently, a new hemostatic product has been introduced in the market, and used as a military wound bandages, the ChitoFlex®. ChitoFlex® is made of chitosan, a naturally occurring, bio-compatible polysaccharide. Because chitosan has a positive charge, it attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, coherent seal. The ChitoFlex® -dressing has been demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) as an antibacterial barrier in laboratory testing with a variety of gram-positive and gram-negative bacterial organisms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: Epistaxis Group

Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.

One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.

Device: 2009-I-Epistaxis-1
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.
Other Names:
  • Epistaxis
  • Chitosan
  • Chitin
  • Hemostatic
  • Nose bleed
  • Nasal bleeding
  • Nasal pack
  • Sealant
  • ChitoFlex®
  • HemCon
  • HemCon® ChitoFlex Surgical Dressing
  • HemCon® Nasal Plugs
  • biocompatible polysaccharide

Primary Outcome Measures :
  1. This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office. [ Time Frame: Removal: 48 hours. Follow-up: 1 week. ]
  2. Hemostasis Success [ Time Frame: From procedure to hemostasis. ]
    Successful hemostasis prior to leaving physician's office

Secondary Outcome Measures :
  1. This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material. [ Time Frame: Removal: 48 hours. Follow-up: 1 week. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Minimum age of 18 years.
  • Epistaxis despite nasal packing or rebleeding after removal of the packing.

Exclusion Criteria:

  • Patient unable or unwilling to provide informed consent.
  • Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863356

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United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
HemCon Medical Technologies, Inc
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Principal Investigator: Alan H. Shikani, MD, FACS Union Memorial Hospital
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Responsible Party: HemCon Medical Technologies, Inc Identifier: NCT00863356    
Other Study ID Numbers: 2009-I-Epistaxis-1
First Posted: March 18, 2009    Key Record Dates
Results First Posted: November 28, 2012
Last Update Posted: November 28, 2012
Last Verified: September 2012
Keywords provided by HemCon Medical Technologies, Inc:
Nose bleed
Nasal bleeding
Nasal pack
HemCon® ChitoFlex Surgical Dressing
HemCon® Nasal Plugs
Biocompatible dressing
Additional relevant MeSH terms:
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Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents