Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00242437
Other study ID # 400-05-002
Secondary ID
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
Est. primary completion date
Accepts healthy volunteers
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT03584178 - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis N/A
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Active, not recruiting NCT02278484 - Sinus Balloon Dilation in Pediatric Patients N/A
Withdrawn NCT02071667 - Association of Periostin Levels and Chronic Sinusitis N/A
Completed NCT01420471 - Medicated Punctured-Glove-Finger Spacer Study Phase 4
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00645762 - Balloon REmodeling Antrostomy THErapy Study Phase 2
Completed NCT01685229 - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting NCT03943121 - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps N/A
Withdrawn NCT02900794 - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery N/A
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT01442740 - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients N/A
Completed NCT01001039 - Validation of the Facial and Cephalic Pain Inventory N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Completed NCT00335309 - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis N/A
Completed NCT00236522 - A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. Phase 3
Completed NCT01717274 - Hot Saline Irrigation Study N/A
Completed NCT01166945 - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children N/A
Completed NCT00747747 - Sinuclean's Treatment Of Sinusitis' Symptoms Phase 4
Not yet recruiting NCT00545961 - Middle Meatal Bacteriology During Acute Respiratory Infection in Children Phase 4