Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery
Stopped early · Not applicable
Conditions studied: Chronic Sinusitis
In brief
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 use of no packing material.
Key facts
- Study ID
- NCT00140608
- Run by
- Genzyme, a Sanofi Company
- Starts
- 2003-06-01
- Expected to finish
- 2005-05-01
- Last updated by the study team
- 2015-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, North Carolina, United States
- University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
- UT Health Science Center — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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