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Abscess Drainage with or Without Antibiotics in Lactational Breast Abscess: A Single-Center, Randomized, Open-Label, Non-Inferior Clinical Trial

Guangzhou Lactational-Breast-Abscess Antibiotic Drainage Trial (the GLAD trial)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024008
Enrollment
Unknown
Registered
2019-06-22
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast disease

Interventions

non-antibiotics group:simple drainage without antibiotics
antibiotics group :drainage combined with antibiotics

Sponsors

Guangzhou Women and Children`s Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: 1) Breastfeeding females, age ranging from 18 to 45 years; 2) Confirmed diagnosis of lactational breast abscess; 3) Measurable swelling by ultrasonography; 4) Obtainment of written informed consent before inclusion; 5) Awareness of trial details as well as agreement with study process, intervention and follow-up.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: 1) Incapable of giving informed consent (eg: linguistic obstacle); 2) Concomitant vital organ dysfunction, hematological diseases, mental disorders; 3) History of breast carcinoma or history of breast surgeries; 4) Patients with surgical contradictions; 5) Suspicion of sepsis, or refractory infections; 6) Immunocompromised patients (eg: patients with history of chemotherapy, organ transplant and any immuno-deficient conditions); 7) Concomitant antibiotic usage for other indication; 8) Known allergy of study medications; 9) Repeated high fever with administration of antibiotics; 10) Patients with other infectious wounds.

Design outcomes

Primary

MeasureTime frame
time to resolution of breast abscess;recurrence rate;

Secondary

MeasureTime frame
3-day-improvement proportion;rate of continuing breastfeeding;length of hospital stay;procedure-related complications;

Countries

China

Contacts

Public ContactGuanhua Li

Guangzhou Women and Children`s Medical Center

dr.liguanhua@hotmail.com+86 13828473633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026