An observational study in Breast Abscess, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Sohag University · Observational
Breast abscess is a localized suppurative complication of breast infection commonly managed by ultrasound-guided needle aspiration combined with antibiotic therapy. This prospective observational study aims to evaluate the clinical outcomes and prognostic factors associated with successful non-surgical management versus treatment failure requiring surgical intervention in adult female patients with lactational and non-lactational breast abscesses.
Breast abscess represents a severe complication of mastitis encountered in lactating and non-lactating women. While traditional management relied on incision and drainage, modern approaches emphasize minimally invasive non-surgical treatment using ultrasound-guided needle aspiration combined with appropriate antibiotics to minimize morbidity, accelerate healing, avoid fistula formation, and preserve breastfeeding. This prospective observational study will be conducted at the Department of General Surgery, Sohag University Hospitals. Eligible female patients presenting with lactational or non-lactational breast abscesses will undergo initial non-surgical treatment with ultrasound-guided needle aspiration/re-aspiration with or without catheter drainage plus culture-guided antibiotic therapy. Patients will be followed up clinically and sonographically for 4 weeks to evaluate treatment success, time to resolution, complication rates, and predictors associated with treatment failure requiring surgical intervention.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's planned enrollment of 50 is below the median of 211 across 14 observational studies indexed under Mastitis.
Browse Mastitis studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult female patients presenting with lactational or non-lactational breast abscesses eligible for non-surgical care at the General Surgery outpatient clinic or emergency unit at Sohag University Hospitals.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult female patients presenting with lactational or non-lactational breast abscess undergoing initial non-surgical management via ultrasound-guided needle aspiration with or without catheter drainage plus systemic antibiotic therapy.
Procedure: Ultrasound-guided needle aspiration and antibiotics
Ultrasound-guided needle aspiration of the abscess cavity (repeated every 2-3 days if residual collection persists) with or without catheter drainage, combined with systemic empirical and culture-sensitive antibiotic therapy.
Successful Non-Surgical Management Rate
Complete clinical and sonographic resolution of the breast abscess without the necessity of formal surgical incision and drainage during the index episode.
Time frame: Up to 4 weeks post-treatment
Time to Complete Resolution
Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Time frame: Up to 4 weeks
Number of Aspiration Sessions
Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Time frame: Up to 4 weeks
Rate of Treatment Failure Requiring Surgical Intervention
Percentage of patients who failed non-surgical management and required formal surgical incision and drainage.
Time frame: Up to 4 weeks
Rate of Procedure-Related Complications
Incidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.
Time frame: Up to 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
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