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Ductal Lavage in Non-lactating Female Women With Mastitis

NCT02794688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2019-08-22

No results posted yet for this study

Summary

RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators hypothesized that ductal lavage is able to relieve the symptoms and achieve complete response, with shorter recovery time than oral intake of antibiotics or corticosteroids treatments. This single arm, observational, case series, pilot study is going to evaluate the effectiveness of ductal lavage in patients with non-lactational IGM or PD.

Conditions

  • Mastitis

Interventions

PROCEDURE

Ductal lavage therapy

1. Patient lies in supine position, with routine sterilizing and draping procedure. 2. Local anesthesia with 2ml lidocaine (1%) around the nipple. 3. Identification of 4-5 openings of the lactiferous ducts from the nipple. 4. Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts. 5. Start the infusion pump with 15ml irrigation solution (2% Lidocaine 5ml, Triamcinolone acetonide 40mg，0.9% saline 10ml and ceftriaxone 1.0g). If the patients had elevated white blood cell count and fever (\>38 celsius degree), oral intake or infusion of antibiotics were allowed, when necessary. 6. The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage. 7. Repeat step 1-6 every other day for 2 weeks. 8. Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed.

Sponsors & Collaborators

  • Guangzhou Jie Jian Instrument Co,Ltd

    collaborator UNKNOWN

  • China Anti-aging Promoting Association

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Shunrong Li, M.D. · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Erwei Song, M.D. · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-07-31
Completion
2019-06-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794688 on ClinicalTrials.gov