SPACK00104ORP: 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	Phase
Chronic Sinusitus	Device: Seprapack Sinus Dressing	N/A

Study Type: Interventional

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

Further Study Details:

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

Study Start: 2003-06; Study Completion: 2005-05

Eligibility

Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both

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

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

Location Information

North Carolina
Medical University of South Carolina, Charleston, North Carolina, 29425, United States

Ohio
University of Cincinnati College of Medicine, Cincinnati, Ohio, 45267, United States

Tennessee
UT Health Science Center, Memphis, Tennessee, 38163, United States

More Information

Study ID Numbers SPACK00104ORP
Clinicaltrials.gov Identifier NCT00140608
Health Authority: United States: Institutional Review Board