NCT00863356

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 28, 2012

Completed
Last Updated

November 28, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

March 16, 2009

Results QC Date

October 29, 2012

Last Update Submit

October 29, 2012

Conditions

Epistaxis

Keywords

EpistaxisChitosanHemostaticNose bleedNasal bleedingNasal packSealantChitoFlex®HemConHemCon® ChitoFlex Surgical DressingHemCon® Nasal PlugsBiocompatible dressing

Outcome Measures

Primary Outcomes (2)

  • 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.

    Removal: 48 hours. Follow-up: 1 week.

  • Hemostasis Success

    Successful hemostasis prior to leaving physician's office

    From procedure to hemostasis.

Secondary Outcomes (1)

  • 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.

    Removal: 48 hours. Follow-up: 1 week.

Study Arms (1)

Epistaxis Group

EXPERIMENTAL

Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing. One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material.

Device: 2009-I-Epistaxis-1

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.

Also known as: Epistaxis, Chitosan, Chitin, Hemostatic, Nose bleed, Nasal bleeding, Nasal pack, Sealant, ChitoFlex®, HemCon, HemCon® ChitoFlex Surgical Dressing, HemCon® Nasal Plugs, biocompatible polysaccharide
Epistaxis Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Epistaxis

Interventions

Hemostatic Techniques

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
V.P., Clinical Affairs
Organization
HemCon Medical Technologies
jody.oyama@hemcon.com
971.223.4904

Study Officials

  • Alan H. Shikani, MD, FACS

    Union Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 18, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

November 28, 2012

Results First Posted

November 28, 2012

Record last verified: 2012-09

Locations

US(1)