Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery

Genzyme

Status

Terminated

Conditions

Chronic Sinusitis

Treatments

Device: Seprapack Sinus Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT00140608

SPACK00104ORP

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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