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

Chronic Sinusitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00140608
• Other study ID #: SPACK00104ORP
• Status: Terminated
• Phase: N/A
• First received: August 29, 2005
• Last updated: March 17, 2015
• Start date: June 2003
• Est. completion date: May 2005

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis

Intervention

Device:
• Seprapack Sinus Dressing

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	North Carolina
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	UT Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in post-operative scarring when compared to use of no sinus packing