Gore Tex Implants in the Treatment of Atrophic Rhinitis (RA)

January 29, 2009 updated by: Hospital Felicio Rocho

This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa.

The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment.

All patients have improved after the procedure.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.

Study Type

Observational

Enrollment (Actual)

5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.

Description

Inclusion Criteria:

  • Symptoms of atrophic rhinitis, with previous clinical treatment without good results

Exclusion Criteria:

  • Patients with mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
polytetrafluoroethylene
Other: implants of polytetrafluoroethylene in tha nasal fossa
surgical implants of polytetrafluoroethylene in the nasal fossa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement of fetid crusts and atrophy of the mucous bone covering
Time Frame: after surgery recovery
after surgery recovery

Secondary Outcome Measures

Outcome Measure
Time Frame
lack of side effects such as infection
Time Frame: after the treatment
after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Felicio Rocho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rinite Atrófica cep/hfr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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