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

NCT ID: NCT01315080

Last Updated: 2011-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mammillary Fistula

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Saline

Percutaneous drainage and saline solution irrigation

No interventions assigned to this group

Triamcinolone

Percutaneous drainage and saline solution irrigation plus percutaneous triamcinolone

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Virgen de la Arrixaca University Hospital

Principal Investigators

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Juan D Berna, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Virgen de la Arrixaca University Hospital

Locations

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Virgen de la Arrixaca University Hospital

Murcia, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan D Berna, MD PhD

Role: CONTACT

+34 968369500 ext. 29757

Facility Contacts

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Juan D Berna, MD PhD

Role: primary

+34 968369500 ext. 29757

Other Identifiers

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FISTULA001

Identifier Type: -

Identifier Source: org_study_id

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