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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hospital Universitario Virgen de la Arrixaca.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT01315080
First received: March 11, 2011
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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
Mammillary Fistula

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Primary Outcome Measures:
  • Resolution of mammillary fistula [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Saline
Percutaneous drainage and saline solution irrigation
Triamcinolone
Percutaneous drainage and saline solution irrigation plus percutaneous triamcinolone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315080

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

Locations
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
Principal Investigator: Juan D Berna, MD PhD Virgen de la Arrixaca University Hospital
  More Information

No publications provided

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
Study First Received: March 11, 2011
Last Updated: March 14, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario Virgen de la Arrixaca:
mammillary fistula
triamcinolone
ultrasound management
percutaneous treatment

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014