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Hemostatic Matrix in Endoscopic Sinus Surgery

Primary Purpose

Sinusitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hemostatic matrix
bovine thrombin
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • The Summit Medical GroupDepartment of Otolaryngology
  • The Medical University of South Carolina Department of Otolaryngology
  • University of Tennessee Department of Otolaryngology

Outcomes

Primary Outcome Measures

Success in achieving hemostasis after product application

Secondary Outcome Measures

Post operative healing
Patient Satisfaction
Time to hemostasis

Full Information

First Posted
October 19, 2005
Last Updated
July 11, 2006
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00242437
Brief Title
Hemostatic Matrix in Endoscopic Sinus Surgery
Official Title
A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ethicon, Inc.

4. Oversight

5. Study Description

Brief Summary
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Hemostatic matrix
Intervention Type
Device
Intervention Name(s)
bovine thrombin
Primary Outcome Measure Information:
Title
Success in achieving hemostasis after product application
Secondary Outcome Measure Information:
Title
Post operative healing
Title
Patient Satisfaction
Title
Time to hemostasis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hart, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Summit Medical GroupDepartment of Otolaryngology
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
The Medical University of South Carolina Department of Otolaryngology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0550
Country
United States
Facility Name
University of Tennessee Department of Otolaryngology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

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Hemostatic Matrix in Endoscopic Sinus Surgery

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