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Hemostatic Matrix in Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00242437
First received: October 19, 2005
Last updated: July 11, 2006
Last verified: July 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Sinusitis
 Device: Hemostatic matrix
Device: bovine thrombin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Sinusitis
U.S. FDA Resources

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Success in achieving hemostasis after product application

Secondary Outcome Measures:
  • Post operative healing
  • Patient Satisfaction
  • Time to hemostasis

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242437

Locations
United States, New Jersey
The Summit Medical GroupDepartment of Otolaryngology
Summit, New Jersey, United States, 07901
United States, South Carolina
The Medical University of South Carolina Department of Otolaryngology
Charleston, South Carolina, United States, 29425-0550
United States, Tennessee
University of Tennessee Department of Otolaryngology
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: James Hart, MD Ethicon, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242437     History of Changes
Other Study ID Numbers: 400-05-002
Study First Received: October 19, 2005
Last Updated: July 11, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
 Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013