Review of Breast Abscess Management | NCT06225180

Studies
Review of Breast Abscess Management

NCT06225180

Sponsor

Methodist Health System

Status

Terminated

Last Update Posted

Mar 24, 2026Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Breast Abscess

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI leaving institution

Expanded Access Info

Start Date

Jun 29, 2023Actual

Primary Completion Date

Jun 12, 2025Actual

Completion Date

Jun 12, 2025Actual

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Antibiotic days	number of days used antibiotics	5 years
Repeat aspiration	Frequency of aspiration	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

18 years of age

• New diagnosis of N61.1 recorded in their EMR

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Conner McDaniel, MD	Methodist Midlothian Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Institute at Methodist Health System		Dallas	Texas	75203	United States
Methodist Dallas Medical Center