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

This study has been terminated.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00140608
First received: August 29, 2005
Last updated: September 2, 2009
Last verified: August 2005

August 29, 2005
September 2, 2009
June 2003
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reduction in post-operative scarring when compared to use of no sinus packing
Same as current
Complete list of historical versions of study NCT00140608 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Chronic Sinusitis
Device: Seprapack Sinus Dressing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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May 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140608
SPACK00104ORP
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Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP