Clinical trial NCT00863356: Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Official title: Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Keywords: Epistaxis
Chitosan
Hemostatic
Nose bleed
Nasal bleeding
Nasal pack
Sealant
ChitoFlex®
HemCon
HemCon® ChitoFlex Surgical Dressing
HemCon® Nasal Plugs
Biocompatible dressing
Lead sponsor: HemCon Medical Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.)

Primary outcomes:
measure: 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.
timeFrame: Removal: 48 hours. Follow-up: 1 week.
measure: Hemostasis Success
timeFrame: From procedure to hemostasis.
Secondary outcomes:
measure: 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.
timeFrame: Removal: 48 hours. Follow-up: 1 week.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
Study officials:
affiliation: Union Memorial Hospital
name: Alan H. Shikani, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: