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

Mammillary Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315080
• Other study ID #: FISTULA001
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2011
• Last updated: March 14, 2011
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2011
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: Juan D Berna, MD PhD
• Phone: +34 968369500
• Email: jdberna[@]um.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fistula
• Mammillary Fistula

Locations

Country	Name	City	State
Spain	Virgen de la Arrixaca University Hospital	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of mammillary fistula		one year	No