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

• Sponsor: HemCon Medical Technologies, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00863356
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epistaxis	Device: 2009-I-Epistaxis-1	N/A

Detailed Description

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® -dressing has been demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) as an antibacterial barrier in laboratory testing with a variety of gram-positive and gram-negative bacterial organisms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Epistaxis Group 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; Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.; Other Names: Epistaxis Chitosan Chitin Hemostatic Nose bleed Nasal bleeding Nasal pack Sealant ChitoFlex® HemCon HemCon® ChitoFlex Surgical Dressing HemCon® Nasal Plugs biocompatible polysaccharide

Outcome Measures

Primary Outcome Measures

1. 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.]

2. Hemostasis Success [From procedure to hemostasis.]

   Successful hemostasis prior to leaving physician's office

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Union Memorial Hospital	Baltimore	Maryland	United States	21218

Sponsors and Collaborators

• HemCon Medical Technologies, Inc

Investigators

• Principal Investigator: Alan H. Shikani, MD, FACS, Union Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HemCon Medical Technologies, Inc
• ClinicalTrials.gov Identifier: NCT00863356
• Other Study ID Numbers: 2009-I-Epistaxis-1
• First Posted: Mar 18, 2009
• Last Update Posted: Nov 28, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by HemCon Medical Technologies, Inc: Epistaxis; Chitosan; Hemostatic; Nose bleed; Nasal bleeding; Nasal pack; Sealant; ChitoFlex®; HemCon; HemCon® ChitoFlex Surgical Dressing; HemCon® Nasal Plugs; Biocompatible dressing
• Additional relevant MeSH terms: Epistaxis; Hemostatics; Chitosan

Study Results

Participant Flow

Recruitment Details	Patients were recruited from a tertiary rhinology fellowship training clinic from January 2009 to November 2009.

Arm/Group Title	Epistaxis Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Epistaxis Group
Arm/Group Description	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.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 45%
>=65 years	11 55%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (19)
Sex: Female, Male (Count of Participants)
Female	12 60%
Male	8 40%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	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.
Time Frame	Removal: 48 hours. Follow-up: 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	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.
Time Frame	Removal: 48 hours. Follow-up: 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Hemostasis Success
Description	Successful hemostasis prior to leaving physician's office
Time Frame	From procedure to hemostasis.

Outcome Measure Data

Analysis Population Description

All enrolled subjects

Arm/Group Title	Epistaxis Group
Arm/Group Description	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.
Measure Participants	20
Number [percentage of participants]	20 100%

Adverse Events

Arm/Group Title	Epistaxis Group
Arm/Group Description	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.
All Cause Mortality
	Epistaxis Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Epistaxis Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Epistaxis Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.