Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula

March 14, 2011 updated by: Hospital Universitario Virgen de la Arrixaca
The investigators recently proposed a new hypothesis on the pathogenesis of mammillary fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may relevantly contribute to the development of MF. The investigators believe that the pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical entities manifest themselves as a chronic, suppurative and recurrent inflammatory process. This new proposal has led to the present suggestion of a therapeutic alternative for MF.

Study Overview

Status

Unknown

Conditions

Detailed Description

To compare the results from a prospective observational database with two groups of patients:

  1. patients with MF treated by percutaneous drainage and saline solution.
  2. patients with MF treated by percutaneous drainage and saline solution plus percutaneous triamcinolone.

These patients are treated following usual clinical practice in our Department. All the procedures are made through an ultrasound-guided way. During the follow-up of these cases (clinical and with ultrasound) resolution rate will be registered by the same investigator.

The follow-up will be at least 6 months.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Virgen de la Arrixaca University Hospital
        • Contact:
          • Juan D Berna, MD PhD
          • Phone Number: 29757 +34 968369500
          • Email: jdberna@um.es

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with mammillary fistula

Description

Inclusion Criteria:

  • mammillary fistula
  • older than 18 years
  • patient acceptation to the recruitment

Exclusion Criteria:

  • diabetes mellitus
  • arterial hypertension
  • immunodepression
  • peptic ulcer
  • chronic bowel inflammatory diseases

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-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Saline
Percutaneous drainage and saline solution irrigation
Triamcinolone
Percutaneous drainage and saline solution irrigation plus percutaneous triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of mammillary fistula
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Juan D Berna, MD PhD, Virgen de la Arrixaca University Hospital

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

March 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 15, 2011

Last Update Submitted That Met QC Criteria

March 14, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISTULA001

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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