EpistaxisNCT00863356
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
A study testing 2009-I-Epistaxis-1 in people with Epistaxis, run by HemCon Medical Technologies, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epistaxis
- What is being tested?
- 2009-I-Epistaxis-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years.
- Epistaxis despite nasal packing or rebleeding after removal of the packing.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epistaxis
- Being tested
- 2009-I-Epistaxis-1
- Keywords
- Epistaxis, Chitosan, Hemostatic, Nose bleed, Nasal bleeding, Nasal pack, Sealant, ChitoFlex®, HemCon, HemCon® ChitoFlex Surgical Dressing, HemCon® Nasal Plugs, Biocompatible dressing
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2009-I-Epistaxis-1Device
Also called Epistaxis, Chitosan, Chitin, Hemostatic
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 2009-I-Epistaxis-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Removal: 48 hours. Follow-up: 1 week.
Hemostasis Success
Successful hemostasis prior to leaving physician's office
Measured: 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.
Measured: Removal: 48 hours. Follow-up: 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemCon Medical Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan H. Shikani, MD, FACS, Principal investigator, Union Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863356
- Sponsor's protocol ID
- 2009-I-Epistaxis-1
- Status last verified
- Sep 2012
- First submitted
- 16 Mar 2009
- Last updated
- 28 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
- ClinicalTrials.gov ID
- NCT00863356
- Acronym / sponsor ID
- 2009-I-Epistaxis-1
- Conditions
- Epistaxis
- Keywords
- Epistaxis, Chitosan, Hemostatic, Nose bleed, Nasal bleeding, Nasal pack, Sealant, ChitoFlex®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HemCon Medical Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 28 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epistaxis Group | Experimental | Device: 2009-I-Epistaxis-1Subjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minimum age of 18 years.
- Epistaxis despite nasal packing or rebleeding after removal of the packing.
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2009-I-Epistaxis-1Also: Epistaxis, Chitosan, Chitin, HemostaticTrial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up. | Device | Epistaxis Group |
Primary outcome
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.
Hemostasis Success
Time frame: From procedure to hemostasis.
Successful hemostasis prior to leaving physician's office
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epistaxis
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A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
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Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
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RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan H. Shikani, MD, FACS principal investigator
Union Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2009-I-Epistaxis-1 in people with Epistaxis, run by HemCon Medical Technologies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.