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Sponsored by: |
HemCon Medical Technologies, Inc |
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Information provided by: | HemCon Medical Technologies, Inc |
ClinicalTrials.gov Identifier: | NCT00863356 |
Purpose:
This study is aimed to be 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.
Condition | Intervention |
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Epistaxis |
Device: 2009-I-Epistaxis-1 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis |
Estimated Enrollment: | 25 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Epistaxis Group: Experimental |
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.
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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®
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Union Memorial Hospital | |
Baltimore, Maryland, United States, 21218 |
Principal Investigator: | Alan H. Shikani, MD, FACS | Union Memorial Hospital |
Responsible Party: | HemCon Medical Technologies, Inc. ( Staci McAdams ) |
Study ID Numbers: | 2009-I-Epistaxis-1 |
Study First Received: | March 16, 2009 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00863356 History of Changes |
Health Authority: | United States: Institutional Review Board |
Epistaxis Chitosan Hemostatic Nose bleed Nasal bleeding Nasal pack |
Sealant ChitoFlex® HemCon HemCon® ChitoFlex Surgical Dressing HemCon® Nasal Plugs Biocompatible dressing |
Antimetabolites Otorhinolaryngologic Diseases Respiratory Tract Diseases Epistaxis Antilipemic Agents |
Chitosan Anticholesteremic Agents Chelating Agents Hemorrhage Hemostatics |
Antimetabolites Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Coagulants Epistaxis Antilipemic Agents Hematologic Agents Anticholesteremic Agents Hemorrhage |
Nose Diseases Hemostatics Pharmacologic Actions Pathologic Processes Respiratory Tract Diseases Therapeutic Uses Chitosan Chelating Agents |