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

October 29, 2012 updated by: HemCon Medical Technologies, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • HemCon
  • Epistaxis
  • Chitosan
  • Chitin
  • Hemostatic
  • Nose bleed
  • Nasal bleeding
  • Nasal pack
  • Sealant
  • ChitoFlex®
  • HemCon® ChitoFlex Surgical Dressing
  • HemCon® Nasal Plugs
  • biocompatible polysaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Removal: 48 hours. Follow-up: 1 week.
Hemostasis Success
Time Frame: From procedure to hemostasis.
Successful hemostasis prior to leaving physician's office
From procedure to hemostasis.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Removal: 48 hours. Follow-up: 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemCon Medical Technologies, Inc

Investigators

  • Principal Investigator: Alan H. Shikani, MD, FACS, Union Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (ESTIMATE)

March 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2012

Last Update Submitted That Met QC Criteria

October 29, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-I-Epistaxis-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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