Hemostatic Matrix in Endoscopic Sinus Surgery

NCT00242437 | Completed Phase 4

• 1 other identifier: 400-05-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Success in achieving hemostasis after product application

Secondary Outcomes (3)

• Post operative healing

• Patient Satisfaction

• Time to hemostasis

Interventions

Hemostatic matrix DEVICE

bovine thrombin DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (3)

The Summit Medical GroupDepartment of Otolaryngology

Summit, New Jersey, 07901, United States

Location

The Medical University of South Carolina Department of Otolaryngology

Charleston, South Carolina, 29425-0550, United States

Location

University of Tennessee Department of Otolaryngology

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• James Hart, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 20, 2005
• Study Start: October 1, 2005
• Study Completion: February 1, 2006
• Last Updated: July 13, 2006

Record last verified: 2006-07

Locations

US (3)