Chronic Sinusitis
Conditions
Keywords
sinus
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 use of no packing material.
Interventions
DEVICESeprapack Sinus Dressing
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in post-operative scarring when compared to use of no sinus packing | — |
Countries
United States
Outcome results
None listed