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Abscess Drainage with or Without Antibiotics in Lactational Breast Abscess: Study Protocol for a Randomized
Jiayue Luo1, Tianzhu Long1, Yuanxuan Cai1
1Department of Breast Surgery, Guangzhou Women and Children`s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong 510623, People's Republic of China.
Infection and Drug Resistance
|February 6, 2020
Summary
This study investigates if simple surgical drainage of lactational breast abscess is as effective as drainage plus antibiotics. Findings could revise antibiotic guidelines for breastfeeding mothers.
Area of Science:
- Obstetrics and Gynecology
- Infectious Diseases
- Surgical Oncology
Background:
- Lactational breast abscess is a frequent complication of mastitis, often leading to breastfeeding cessation.
- Current treatment guidelines lack consensus on the necessity of antibiotics alongside surgical drainage.
- This study addresses the clinical question of antibiotic use in lactational breast abscess management.
Purpose of the Study:
- To determine if simple surgical drainage of lactational breast abscess is non-inferior to abscess drainage combined with a standard antibiotic course.
- To provide evidence for refining treatment protocols and antibiotic prophylaxis in lactational breast abscess.
Main Methods:
- A randomized controlled trial involving 306 breastfeeding females aged 18-50 with breast abscess.
- Participants will be allocated to either simple drainage or drainage plus a 5-day antibiotic course.
- Primary outcomes: time to resolution and recurrence rate; secondary outcomes: breastfeeding continuation, treatment failure, complications, and hospital stay.
Main Results:
- The study aims to establish non-inferiority with a 1-day margin for the primary outcome.
- Analysis will compare resolution time and recurrence rates between the two treatment arms.
- Secondary outcome data will offer a comprehensive view of treatment effectiveness and patient experience.
Conclusions:
- This trial will offer crucial evidence on the non-inferiority of simple drainage versus combined treatment for lactational breast abscess.
- Positive findings could lead to revised indications for antibiotic prophylaxis and updated clinical guidelines.
- The results have the potential to impact clinical practice and improve outcomes for breastfeeding mothers.
