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NCT Number: NCT07777783

Evaluation of Non-Surgical Treatment of Breast Abscess

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Marwa M El-Sawy, MBBCh

CONTACT

[email protected]

201122535533

Marwa M El-Sawy, MBBCh

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided needle aspiration and antibiotics

Procedure

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.

Primary outcomes

  1. Successful Non-Surgical Management Rate

    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.

Secondary outcomes

  1. Time to Complete Resolution

    Time frame: Up to 4 weeks

    Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.

  2. Number of Aspiration Sessions

    Time frame: Up to 4 weeks

    Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.

  3. Rate of Treatment Failure Requiring Surgical Intervention

    Time frame: Up to 4 weeks

    Percentage of patients who failed non-surgical management and required formal surgical incision and drainage.

  4. Rate of Procedure-Related Complications

    Time frame: Up to 4 weeks

    Incidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Evaluation of the Non-Surgical Treatment of Breast Abscess

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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