Hemostatic Matrix in Endoscopic Sinus Surgery

Sinusitis Clinical Trial

Official title:

A Prospective, Multicenter Study to Evaluate Hemostatic Matrix With Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242437
• Other study ID #: 400-05-002
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2005
• Last updated: July 11, 2006
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: July 2006
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• Hemostatic matrix

• bovine thrombin

Locations

Country	Name	City	State
United States	The Medical University of South Carolina Department of Otolaryngology	Charleston	South Carolina
United States	University of Tennessee Department of Otolaryngology	Memphis	Tennessee
United States	The Summit Medical GroupDepartment of Otolaryngology	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in achieving hemostasis after product application
Secondary	Post operative healing
Secondary	Patient Satisfaction
Secondary	Time to hemostasis