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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140608
First Posted: September 1, 2005
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
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.

Condition Intervention
Chronic Sinusitis Device: Seprapack Sinus Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • reduction in post-operative scarring when compared to use of no sinus packing

Study Start Date: June 2003
Estimated Study Completion Date: May 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140608


Locations
United States, North Carolina
Medical University of South Carolina
Charleston, North Carolina, United States, 29425
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
United States, Tennessee
UT Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00140608     History of Changes
Other Study ID Numbers: SPACK00104ORP
First Submitted: August 29, 2005
First Posted: September 1, 2005
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
sinus

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases