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

NCT00863356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-11-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • HemCon Medical Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Alan H. Shikani, MD, FACS · Union Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00863356 on ClinicalTrials.gov