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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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