Hemostatic Matrix in Endoscopic Sinus Surgery

NCT ID: NCT00242437

Last Updated: 2006-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-02-28

Brief Summary

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

Conditions

Sinusitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Hemostatic matrix

Intervention Type: DEVICE

bovine thrombin

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

James Hart, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

The Summit Medical GroupDepartment of Otolaryngology

Summit, New Jersey, 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

Countries

United States

Other Identifiers

400-05-002

Identifier Type: -

Identifier Source: org_study_id