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

Primary Purpose

Chronic Sinusitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seprapack Sinus Dressing
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring sinus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of South Carolina
  • University of Cincinnati College of Medicine
  • UT Health Science Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00140608
Brief Title
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
sinus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Seprapack Sinus Dressing
Primary Outcome Measure Information:
Title
reduction in post-operative scarring when compared to use of no sinus packing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
UT Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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