Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis - Full Text View

Sponsored by:	HemCon Medical Technologies, Inc
Information provided by:	HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:	NCT00863356

Purpose

Purpose:

This study is aimed to be 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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Chitosan

U.S. FDA Resources

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

Primary Outcome Measures:

This study aims to demonstrate 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 ]

Secondary Outcome Measures:

This study should help determine 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 ]

Estimated Enrollment:	25
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Epistaxis Group: Experimental	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.

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

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. ( Staci McAdams )
Study ID Numbers:	2009-I-Epistaxis-1
Study First Received:	March 16, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00863356 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Epistaxis
Antilipemic Agents
Chitosan

Chitin
Anticholesteremic Agents
Chelating Agents
Hemorrhage
Hemostatics

Additional relevant MeSH terms:

Antimetabolites
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Coagulants
Epistaxis
Antilipemic Agents
Hematologic Agents
Anticholesteremic Agents
Hemorrhage

Nose Diseases
Hemostatics
Pharmacologic Actions
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Chitosan
Chelating Agents

ClinicalTrials.gov processed this record on September 11, 2009