Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula
Recruitment status was Recruiting
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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 |
- 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:
- patients with MF treated by percutaneous drainage and saline solution.
- 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 |
Patients with mammillary fistula
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| Contact: Juan D Berna, MD PhD | +34 968369500 ext 29757 | jdberna@um.es |
| Spain | |
| Virgen de la Arrixaca University Hospital | Recruiting |
| Murcia, Spain, 30120 | |
| Contact: Juan D Berna, MD PhD +34 968369500 ext 29757 jdberna@um.es | |
| 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 May 16, 2013