Evaluation of Non-Surgical Treatment of Breast Abscess

August 17, 2026 updated by: Marwa Elsawy Mohamed, Sohag University

Evaluation of the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag university hospital
        • Contact:
        • Principal Investigator:
          • Marwa M El-Sawy, MBBCh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Surgical Treatment Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Complete Resolution
Time Frame: Up to 4 weeks
Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Up to 4 weeks
Number of Aspiration Sessions
Time Frame: Up to 4 weeks
Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Up to 4 weeks
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.
Up to 4 weeks
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.
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-7-12MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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