Review of Breast Abscess Management

Breast Abscess Clinical Trial

Official title:

Review of Breast Abscess Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225180
• Other study ID #: 021.TRA.2023.D
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: June 29, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Kavya Vinod Mankulangara
• Phone: 214-947-1281
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Breast Abscess

Locations

Country	Name	City	State
United States	Clinical Research Institute at Methodist Health System	Dallas	Texas
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibiotic days	number of days used antibiotics	5 years
Secondary	Repeat aspiration	Frequency of aspiration	5 years
Secondary	Return to Emergency Department ( ED)	Number of times of ED visit	5 years