Status:
TERMINATED
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate if the space occupying effect of Seprapack will lead to a reduction in post operative adhesions and more healing of the sinus cavity when compared to the us...
Eligibility Criteria
Inclusion
- at least 18 years of age
- requiring bilateral endoscopic ethmoidectomy (anterior or posterior)
- intact middle turbinates
- willing to return for all follow-up visits
- signed written informed consent
Exclusion
- patients with craniofacial abnormalities (e.g. cleft palate)
- patients without intact middle turbinates
- patients on long-term oral steroids or other chemotherapeutic agents that might delay healing. Short-term pulse steroid therapy and topical steroids are acceptable
- patients with inflammatory conditions, other than chronic sinusitis or nasal polyposis, including but not limited to sarcoidosis, rhinitis, ozena, Wegner's granulomatosis, nasal malignancy, recreational drug abuse
- patients with cystic fibrosis
- women that are pregnant or women of childbearing age potential who are not practicing an acceptable method of birth control
- patients with bleeding disorders or who are receiving anticoagulants
- patients that may require a Lothrop procedure
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00140608
Start Date
June 1 2003
End Date
May 1 2005
Last Update
March 18 2015
Active Locations (3)
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1
Medical University of South Carolina
Charleston, North Carolina, United States, 29425
2
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
3
UT Health Science Center
Memphis, Tennessee, United States, 38163