Abscess Drainage with or Without Antibiotics in Lactational Breast Abscess: Study Protocol for a Randomized Controlled Trial
Open accessAbstract
BACKGROUND: Lactational breast abscess, a complication from lactational mastitis, is a common cause of breastfeeding discontinuation. No consensus has been reached regarding the necessity of antibiotics in this disease. The purpose of this trial is to determine if surgical drainage is non-inferior to drainage together with a standard course of antibiotics, in the treatment of lactational breast abscess. METHODS: Breastfeeding females with breast abscess from 18 to 50 years old are eligible for study inclusion. An expected number of 306 patients will be randomly allocated in parallel to the intervention arm (simple drainage without antibiotics) or the control arm (abscess drainage with standard 5-day-course of antibiotics). The primary outcomes include the time to resolution of breast abscess and disease recurrence rate. Secondary outcomes of interests are 3-day-improvement proportion, rate of continuing breastfeeding, treatment failure rate, procedural-related complications, and length of hospital stay. An expected non-inferiority margin for the difference in the primary outcome of interest is set at 1 day, on the basis of a one-sided 97.5% confidence interval. DISCUSSION: This trial will provide first-hand evidence on whether simple abscess drainage is non-inferior to drainage together with a standard course of antibiotics, in lactational mothers with breast abscess. The indication of antibiotic prophylaxis could be revised if non-inferiority is set up, and guidelines for lactational breast abscess require amendments correspondingly. TRIAL REGISTRATION: This study has been registered in the Chinese Clinical Trial Registry, and the trial registration number is ChiCTR1900024008.
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According to Luo and colleagues, antibiotics were not routinely used for the treatment of breast abscesses during lactation, but the success rate was similar to that of routine antibiotic use.
“However, according to Luo and colleagues [20], antibiotics were not routinely used for the treatment of breast abscesses during lactation, but the success rate was similar to that of routine antibiotic use.”
From Clinical characteristics of lactational breast abscess caused by methicillin-resistant Staphylococcus aureus: hospital-based study in China (2021) · cites this paper as [20]
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Cites
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Cited by
Sorted by citations
Li, Y., Ma, X.-J., & He, X.-P. (2021) · International Breastfeeding Journal · doi:10.1186/s13006-021-00429-6 · Cited by 16 · see citing works
- Authors
- Luo, J., Long, T., Cai, Y., Teng, Y., Fan, Z., Liang, Z., Zhu, C., Ma, H., & Li, G.
- Affiliations
- Guangzhou Women and Children Medical Center (CN)
- Corresponding author
- Luo, Jiayue
- Long, Tianzhu
- Cai, Yuanxuan
- Teng, Yuan
- Fan, Zhe
- Liang, Zhen
- Zhu, Cairong
- Ma, Hongmin
- Li, Guanhua
- Venue
- Infection and Drug Resistance
- Publisher
- Informa UK Limited
- Published
- 2020-01
- Volume
- Volume 13
- Pages
- 183-190
- ISSN
- 1178-6973 (ISSN-L)
- PMC
- PMC6983478
- OpenAlex
- W2999761783
- Cited by
- 16
- References
- 5
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2022: 4 · 2021: 4 · 2020: 2
- FWCI
- 1.79
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Infection and Drug Resistance (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Epidemiology › Breastfeeding Practices and Influences
- Health Sciences › Medicine › Pathology and Forensic Medicine › Breast Lesions and Carcinomas
- Life Sciences › Agricultural and Biological Sciences › Agronomy and Crop Science › Milk Quality and Mastitis in Dairy Cows
- Keywords
- abscess drainage, antibiotic prophylaxis, lactational mastitis, breastfeeding, non-inferiority, recurrence, treatment failure, length of hospital stay
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