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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Seprapack Sinus Dressing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No