CClinicalTrials.gg
CompletedNCT00242437Updated Jul 13, 2006

Hemostatic Matrix in Endoscopic Sinus Surgery

A Phase 4 interventional study of Hemostatic matrix and bovine thrombin in Sinusitis, sponsored by Ethicon, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-07-13.

Sponsored by Ethicon, Inc. · Phase 4, Interventional, and Educational/counseling/training

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Sinusitis

Browse trials for

03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Educational/counseling/training
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DeviceHemostatic matrix
  • Devicebovine thrombin
06

What researchers measure

Primary outcomes

  1. Success in achieving hemostasis after product application

Secondary outcomes

  1. Post operative healing

  2. Patient Satisfaction

  3. Time to hemostasis

07

Study locations

3 sites
  • The Summit Medical GroupDepartment of Otolaryngology
    Summit, New Jersey 07901, United States
  • The Medical University of South Carolina Department of Otolaryngology
    Charleston, South Carolina 29425-0550, United States
  • University of Tennessee Department of Otolaryngology
    Memphis, Tennessee 38163, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00242437
Lead sponsor
Ethicon, Inc.
First posted
Oct 20, 2005
Start date
Oct 2005
Completion
Feb 2006
Last update
Jul 13, 2006

Study contacts

James Hart, MD
study director · Ethicon, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion