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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
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