NCT00863356

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HemCon Medical Technologies, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epistaxis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2009-03-18
• Last updated: 2012-11-28
• Results posted: 2012-11-28

Locations

1 site across 1 country: United States