N/A N=20 Treatment

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

Epistaxis

Bottom Line

View on ClinicalTrials.gov: NCT00863356 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 2009-I-Epistaxis-1 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: HemCon Medical Technologies, Inc
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.	—	—
PRIMARY Hemostasis Success	20	—
SECONDARY This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.	—	—

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.

Eligibility Criteria

Inclusion Criteria

Minimum age of 18 years.
Epistaxis despite nasal packing or rebleeding after removal of the packing.

Exclusion Criteria

Patient unable or unwilling to provide informed consent.
Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00863356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.