NCT06225180

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

March 24, 2026

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

November 14, 2023

Last Update Submit

March 20, 2026

Conditions

Breast Abscess

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Antibiotic days

    5 years

  • Repeat aspiration

    5 years

  • Return to Emergency Department ( ED)

    5 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18 years of age • New diagnosis of N61.1 recorded in their EMR

You may qualify if:

  • ≥18 years of age
  • New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)

You may not qualify if:

  • \<18 years of age
  • Pregnant
  • Incarcerated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Conner McDaniel, MD

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

January 25, 2024

Study Start

June 29, 2023

Primary Completion

June 12, 2025

Study Completion

June 12, 2025

Last Updated

March 24, 2026

Record last verified: 2025-06

Locations

US(2)