CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
2009-I-Epistaxis-1device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00863356
NCT00863356N/ACompleted
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Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis

HemCon Medical Technologies, Inc·interventional·Posted Mar 18, 2009·Updated Nov 28, 2012

In Brief

A clinical study evaluating 2009-I-Epistaxis-1 for Epistaxis. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpistaxis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago

Interventions

2009-I-Epistaxis-1device

Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.