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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT00863356
First received: March 16, 2009
Last updated: October 29, 2012
Last verified: September 2012
  Purpose

Purpose:

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 Intervention
Epistaxis
Device: 2009-I-Epistaxis-1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis

Resource links provided by NLM:


Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Hemostasis Success [ Time Frame: From procedure to hemostasis. ] [ Designated as safety issue: No ]
    Successful hemostasis prior to leaving physician's office


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863356

Locations
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
HemCon Medical Technologies, Inc
Investigators
Principal Investigator: Alan H. Shikani, MD, FACS Union Memorial Hospital
  More Information

No publications provided

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT00863356     History of Changes
Other Study ID Numbers: 2009-I-Epistaxis-1
Study First Received: March 16, 2009
Results First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by HemCon Medical Technologies, Inc:
Epistaxis
Chitosan
Hemostatic
Nose bleed
Nasal bleeding
Nasal pack
Sealant
ChitoFlex®
HemCon
HemCon® ChitoFlex Surgical Dressing
HemCon® Nasal Plugs
Biocompatible dressing

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Hemostatics
Chitosan
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents

ClinicalTrials.gov processed this record on October 16, 2014