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

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ClinicalTrials.gov Identifier: NCT01315080
Recruitment Status : Unknown
Verified March 2011 by Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Recruiting
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Sponsor:
Information provided by:
Hospital Universitario Virgen de la Arrixaca

Brief Summary:
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.

Condition or disease
Mammillary Fistula

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula
Study Start Date : March 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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



Primary Outcome Measures :
  1. Resolution of mammillary fistula [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with mammillary fistula
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315080


Contacts
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Contact: Juan D Berna, MD PhD +34 968369500 ext 29757 jdberna@um.es

Locations
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Spain
Virgen de la Arrixaca University Hospital Recruiting
Murcia, Spain, 30120
Contact: Juan D Berna, MD PhD    +34 968369500 ext 29757    jdberna@um.es   
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Investigators
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Principal Investigator: Juan D Berna, MD PhD Virgen de la Arrixaca University Hospital

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Responsible Party: Juan de Dios Berna Serna, MD PhD, Virgen de la Arrixaca University Hospital
ClinicalTrials.gov Identifier: NCT01315080     History of Changes
Other Study ID Numbers: FISTULA001
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011
Keywords provided by Hospital Universitario Virgen de la Arrixaca:
mammillary fistula
triamcinolone
ultrasound management
percutaneous treatment
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action