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Evaluation of Non-Surgical Treatment of Breast Abscess

Evaluation of the Non-Surgical Treatment of Breast Abscess

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07777783
Enrollment
50
Registered
2026-08-20
Start date
2026-06-01
Completion date
2027-05-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Abscess

Keywords

Ultrasound-guided aspiration, Non-surgical treatment, Needle aspiration, Mastitis

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREUltrasound-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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult female patients diagnosed with lactational and non-lactational breast abscesses on clinical and sonographic grounds. * Patients undergoing initial non-surgical treatment in the form of ultrasound-guided aspiration/re-aspiration with or without catheter drainage plus systemic antibiotics.

Exclusion criteria

* Suspicion of inflammatory breast cancer or underlying breast malignancy. * Frank skin necrosis, thinning, or ruptured abscess overlying the affected breast. * Patients with breast implants in situ on the affected side. * History of breast surgery within 90 days of presentation. * Chronic or recurrent breast abscesses.

Design outcomes

Primary

MeasureTime frameDescription
Successful Non-Surgical Management RateUp to 4 weeks post-treatmentComplete clinical and sonographic resolution of the breast abscess without the necessity of formal surgical incision and drainage during the index episode.

Secondary

MeasureTime frameDescription
Time to Complete ResolutionUp to 4 weeksDuration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Number of Aspiration SessionsUp to 4 weeksTotal number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Rate of Treatment Failure Requiring Surgical InterventionUp to 4 weeksPercentage of patients who failed non-surgical management and required formal surgical incision and drainage.
Rate of Procedure-Related ComplicationsUp to 4 weeksIncidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026