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Abscess Drainage with or Without Antibiotics in Lactational Breast Abscess: Study Protocol for a Randomized Controlled Trial

Authors Luo J, Long T, Cai Y, Teng Y, Fan Z, Liang Z, Zhu C, Ma H, Li G

Received 28 June 2019

Accepted for publication 24 December 2019

Published 21 January 2020 Volume 2020:13 Pages 183—190

DOI https://doi.org/10.2147/IDR.S221037

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Eric Nulens


Jiayue Luo, Tianzhu Long, Yuanxuan Cai, Yuan Teng, Zhe Fan, Zhen Liang, Cairong Zhu, Hongmin Ma, Guanhua Li

Department of Breast Surgery, Guangzhou Women and Children`s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong 510623, People’s Republic of China

Correspondence: Guanhua Li; Hongmin Ma
Department of Breast Surgery, Guangzhou Women and Children`s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong 510623, People’s Republic of China
Tel/Fax +86 20 8188 6332
Email dr.liguanhua@hotmail.com; dr_mahongmin@sina.com.cn

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.

Keywords: lactational breast abscess, antibiotics, drainage, randomized controlled trial, study protocol

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