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

Completed · Not applicable

Conditions studied: Epistaxis

In brief

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.

Key facts

Study ID

NCT00863356

Run by

HemCon Medical Technologies, Inc

People needed

20

Starts

2009-03-01

Expected to finish

2009-06-01

Last updated by the study team

2012-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.)

Where it is running

• Union Memorial Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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