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TerminatedNCT00140608Updated Mar 18, 2015

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

An interventional study of Seprapack Sinus Dressing in Chronic Sinusitis, sponsored by Genzyme, a Sanofi Company. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Genzyme, a Sanofi Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Sinusitis

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Keywords

  • sinus
03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

Browse Sinusitis studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single

Interventions

  • DeviceSeprapack Sinus Dressing
06

What researchers measure

Primary outcomes

  1. reduction in post-operative scarring when compared to use of no sinus packing

07

Study locations

3 sites
  • Medical University of South Carolina
    Charleston, North Carolina 29425, United States
  • University of Cincinnati College of Medicine
    Cincinnati, Ohio 45267, United States
  • UT Health Science Center
    Memphis, Tennessee 38163, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00140608
Lead sponsor
Genzyme, a Sanofi Company
First posted
Sep 1, 2005
Start date
Jun 2003
Completion
May 2005
Last update
Mar 18, 2015

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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