Sohag University Hospital
Sohag, Egypt
Location status: Recruiting
Location contact
Marwa M El-Sawy, MBBCh
CONTACT
Marwa M El-Sawy, MBBCh
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07777783
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Sohag, Egypt
Location status: Recruiting
Marwa M El-Sawy, MBBCh
CONTACT
Marwa M El-Sawy, MBBCh
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 4 weeks post-treatment
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
Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Time frame: Up to 4 weeks
Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Time frame: Up to 4 weeks
Percentage of patients who failed non-surgical management and required formal surgical incision and drainage.
Time frame: Up to 4 weeks
Incidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.
Sohag University
Other
Evaluation of the Non-Surgical Treatment of Breast Abscess
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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