Trial of a Novel Chitosan Hemostatic Sealant in the Management of

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Epistaxis

Clinical Trial Details

NCT number	NCT00863356
Study type	Interventional
Source	HemCon Medical Technologies, Inc
Contact
Status	Completed
Phase	N/A
Start date	March 2009
Completion date	June 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05334017` - Xylometazoline and Cocaine for Nasal Vasoconstriction	Phase 4
Not yet recruiting	`NCT04519463` - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing	Early Phase 1
Recruiting	`NCT01886768` - Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy	N/A
Recruiting	`NCT00390663` - A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children	Phase 4
Suspended	`NCT04054687` - Intranasal TXA for Anterior Epistaxis in the Emergency Department	Phase 2
Completed	`NCT02285634` - The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.	N/A
Completed	`NCT01485224` - Efficacy of Thalidomide in the Treatment of Hereditary Hemorrhagic Telangiectasia	Phase 2
Completed	`NCT00793117` - The Effect of Packing in Post Operative Management of FESS	Phase 4
Recruiting	`NCT06259292` - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting	`NCT03850964` - Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)	Phase 2/Phase 3
Recruiting	`NCT05281952` - Medico-economic Evaluation of Management Strategies for Severe Epistaxis	N/A
Completed	`NCT04279288` - The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures	N/A
Completed	`NCT03360045` - Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis	Phase 4
Completed	`NCT03912051` - Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting	N/A
Not yet recruiting	`NCT02677467` - Correlation Between Epistaxis and Cardiovascular Disease	N/A
Completed	`NCT01314274` - Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)	Phase 2
Terminated	`NCT01051427` - Control of Epistaxis With Surgiflo	N/A
Recruiting	`NCT05269849` - Sirolimus for Nosebleeds in HHT	Phase 2
Not yet recruiting	`NCT05343650` - NOVAPAK Nasal Packing in Shellfish Allergic Patients	Phase 4
Not yet recruiting	`NCT02963129` - Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms