Review of Breast Abscess Management

Recruiting

• Conditions: Breast Abscess

• Registration Number: NCT06225180
• Lead Sponsor: Methodist Health System

Brief Summary

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.

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 Timeline

• Study Start: 2023-06-29
• Study First Submitted: 2023-11-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antibiotic days	5 years	number of days used antibiotics
Repeat aspiration	5 years	Frequency of aspiration
Return to Emergency Department ( ED)	5 years	Number of times of ED visit

Trial Locations

Locations (2)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States

Clinical Research Institute at Methodist Health System; 🇺🇸 Dallas, Texas, United States