Breast AbscessNCT06225180
Review of Breast Abscess Management
An observational study of Breast Abscess, run by Methodist Health System at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Abscess
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2023to 12 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years of age • New diagnosis of N61.1 recorded in their EMR
Who may be able to join
- • ≥18 years of age
- New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)
Who cannot join
- • <18 years of age
- Pregnant
- Incarcerated
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
Read the 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.
- Conditions
- Breast Abscess
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (3)
Antibiotic days
number of days used antibiotics
Measured: 5 years
Repeat aspiration
Frequency of aspiration
Measured: 5 years
Return to Emergency Department ( ED)
Number of times of ED visit
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start29 Jun 2023
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conner McDaniel, MD, Principal investigator, Methodist Midlothian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225180
- Sponsor's protocol ID
- 021.TRA.2023.D
- Status last verified
- Jun 2025
- First submitted
- 14 Nov 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Breast Abscess Management
- ClinicalTrials.gov ID
- NCT06225180
- Acronym / sponsor ID
- 021.TRA.2023.D
- Conditions
- Breast Abscess
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years of age • New diagnosis of N61.1 recorded in their EMR
Key inclusion criteria (2 listed)
- • ≥18 years of age
Key exclusion criteria (3 listed)
- • <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of repeat interventions prior to resolution of abscess(s)
Time frame: 5 years
Determine the superiority of aspiration vs incision as primary intervention in treatment of breast abscesses
3 secondary outcomes
Antibiotic days
Time frame: 5 years
Repeat aspiration
Time frame: 5 years
Return to Emergency Department ( ED)
Time frame: 5 years
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conner McDaniel, MD principal investigator
Methodist Midlothian Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Abscess, run by Methodist Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of repeat interventions prior to resolution of abscess(s) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.