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

Epistaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863356
• Other study ID #: 2009-I-Epistaxis-1
• Status: Completed
• Phase: N/A
• First received: March 16, 2009
• Last updated: October 29, 2012
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: HemCon Medical Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis

Intervention

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.

Locations

Country	Name	City	State
United States	Union Memorial Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
HemCon Medical Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Removal: 48 hours. Follow-up: 1 week.	Yes
Primary	Hemostasis Success	Successful hemostasis prior to leaving physician's office	From procedure to hemostasis.	No
Secondary	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.		Removal: 48 hours. Follow-up: 1 week.	Yes