- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242437
Hemostatic Matrix in Endoscopic Sinus Surgery
July 11, 2006 updated by: Ethicon, Inc.
A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
New Jersey
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Summit, New Jersey, United States, 07901
- The Summit Medical GroupDepartment of Otolaryngology
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South Carolina
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Charleston, South Carolina, United States, 29425-0550
- The Medical University of South Carolina Department of Otolaryngology
-
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee Department of Otolaryngology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are 18 years or older.
- Patients undergoing elective primary or re-do endoscopic sinus surgery for chronic sinusitis with bleeding surface requiring an adjunct to achieve hemostasis.
- Patients must be willing and capable of cooperating to the extent and degree required by the protocol and sign the IRB approved Informed Consent Form prior to any participation in the study.
Exclusion Criteria:
- Patients with bleeding diathesis, pathologic coagulopathy, systemic disorders, inflammatory conditions (other than chronic sinusitis or nasal polyposis) or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
- Patients with severe (brisk or forceful) bleeding site(s).
- Patients undergoing urgent or emergency endoscopic sinus surgery.
- Patients with bronchial asthma who have aspirin intolerance.
- Patients with diffuse polyposis that would require chronic oral steroids or patients on chemotherapeutic agents that might delay healing (short term pulse steroid therapy and topical steroids are acceptable).
- Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 7 days prior to surgery.
- Patients who are morbidly obese (Body Mass Index > 35).
- Patients with acute local infection at the operative side.
- Patients who are current alcohol and/or drug abusers.
- Patients with neoplasm, craniofacial abnormalities (e.g. cleft palate), or sleep apnea using nasal CPAP, or patients that may require a Lothrop procedure.
- Female patients who are pregnant or nursing.
- Patients who have uncontrolled diabetes mellitus (blood glucose levels >400 mg/dl) as determined by the Investigator based on medical history.
- Patients who have participated in another investigational drug or device research within 30 days of enrollment.
- Patients with known antibodies to bovine thrombin preparations, sensitivities or religious prohibitions to porcine gelatin or bovine components.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Success in achieving hemostasis after product application
|
Secondary Outcome Measures
Outcome Measure |
---|
Patient Satisfaction
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Time to hemostasis
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Post operative healing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 20, 2005
Study Record Updates
Last Update Posted (Estimate)
July 13, 2006
Last Update Submitted That Met QC Criteria
July 11, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 400-05-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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