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

This study has been terminated.

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00140608

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 Sinusitus	Device: Seprapack Sinus Dressing

MedlinePlus related topics: Adhesions Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Genzyme:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 steriods 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
woemn 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators

Study Director:

David Perkins, R. Ph.

Genzyme

More Information

No publications provided

Study ID Numbers:	SPACK00104ORP
Study First Received:	August 29, 2005
Last Updated:	December 9, 2005
ClinicalTrials.gov Identifier:	NCT00140608
Health Authority:	United States: Institutional Review Board

Keywords provided by Genzyme:

sinus

Study placed in the following topic categories:

Adhesions

ClinicalTrials.gov processed this record on February 12, 2009