Review of Breast Abscess Management

Breast abscesses are an unfortunate pathology that develop in patients, and treatment is often painful and unpleasant. The goal of this study is to identify risk factors associated with failure of aspiration as a primary intervention as opposed to incision and drainage in the hopes of adequately treating patients at initial presentation.

Study Overview

• Status: Terminated
• Conditions: Breast Abscess

Detailed Description

The pendulum has now swung toward minimally invasive aspiration as the primary treatment modality, with multiple studies reporting superior cosmetic results. However, patients in these studies often required repeat breast aspirations, and sometimes ultimately required incision and drainage. Aspiration first for treatment of breast abscess may not be a wise choice for all patients if it results in increased antibiotic days, return to emergency department (ED)/increased cost, or prolonged pain from multiple procedures. Several studies have identified varying risk factors for aspiration failure as primary intervention for breast abscesses. More data is needed to confirm the true risk factors for failure.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center
    • Dallas, Texas, United States, 75203
      • Clinical Research Institute at Methodist Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

18 years of age

• New diagnosis of N61.1 recorded in their EMR

Description

Inclusion Criteria:

• • ≥18 years of age

  • New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)

Exclusion Criteria:

• • <18 years of age

  • Pregnant
  • Incarcerated

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of repeat interventions prior to resolution of abscess(s)	Determine the superiority of aspiration vs incision as primary intervention in treatment of breast abscesses	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic days	number of days used antibiotics	5 years
Repeat aspiration	Frequency of aspiration	5 years
Return to Emergency Department ( ED)	Number of times of ED visit	5 years

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Conner McDaniel, MD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: 021.TRA.2023.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No