Breast AbscessNCT07777783
Evaluation of Non-Surgical Treatment of Breast Abscess
An observational study of Breast Abscess, run by Sohag University at 1 site in Egypt.
Trial summary
Breast abscess is a localized suppurative complication of breast infection commonly managed by ultrasound-guided needle aspiration combined with antibiotic therapy. This prospective observational study aims to evaluate the clinical outcomes and prognostic factors associated with successful non-surgical management… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Abscess
- What is being tested?
- Ultrasound-guided needle aspiration and antibiotics
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients presenting with lactational or non-lactational breast abscesses eligible for non-surgical care at the General Surgery outpatient clinic or emergency unit at Sohag University Hospitals.
Who may be able to join
- Adult female patients diagnosed with lactational and non-lactational breast abscesses on clinical and sonographic grounds.
- Patients undergoing initial non-surgical treatment in the form of ultrasound-guided aspiration/re-aspiration with or without catheter drainage plus systemic antibiotics.
Who cannot join
- Suspicion of inflammatory breast cancer or underlying breast malignancy.
- Frank skin necrosis, thinning, or ruptured abscess overlying the affected breast.
- Patients with breast implants in situ on the affected side.
- History of breast surgery within 90 days of presentation.
- Chronic or recurrent breast abscesses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Marwa M El-Sawy, MBBCh, 201122535533, ethics@med.sohag.edu.eg
Marwa M El-Sawy, MBBCh
About this study
Official title: Evaluation of the Non-Surgical Treatment of Breast Abscess
Breast abscess is a localized suppurative complication of breast infection commonly managed by ultrasound-guided needle aspiration combined with antibiotic therapy. This prospective observational study aims to evaluate the clinical outcomes and prognostic factors associated with successful non-surgical management versus treatment failure requiring surgical intervention in adult female patients with lactational and non-lactational breast abscesses.
Read the detailed description
Breast abscess represents a severe complication of mastitis encountered in lactating and non-lactating women. While traditional management relied on incision and drainage, modern approaches emphasize minimally invasive non-surgical treatment using ultrasound-guided needle aspiration combined with appropriate antibiotics to minimize morbidity, accelerate healing, avoid fistula formation, and preserve breastfeeding. This prospective observational study will be conducted at the Department of General Surgery, Sohag University Hospitals. Eligible female patients presenting with lactational or non-lactational breast abscesses will undergo initial non-surgical treatment with ultrasound-guided needle aspiration/re-aspiration with or without catheter drainage plus culture-guided antibiotic therapy. Patients will be followed up clinically and sonographically for 4 weeks to evaluate treatment success, time to resolution, complication rates, and predictors associated with treatment failure requiring surgical intervention.
- Conditions
- Breast Abscess
- Being tested
- Ultrasound-guided needle aspiration and antibiotics
- Keywords
- Ultrasound-guided aspiration, Non-surgical treatment, Needle aspiration, Mastitis
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided needle aspiration and antibioticsProcedure or surgery
Ultrasound-guided needle aspiration of the abscess cavity (repeated every 2-3 days if residual collection persists) with or without catheter drainage, combined with systemic empirical and culture-sensitive antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical Treatment Cohort | Adult female patients presenting with lactational or non-lactational breast abscess undergoing initial non-surgical management via ultrasound-guided needle aspiration with or without catheter drainage plus systemic antibiotic therapy. Receives: Procedure: Ultrasound-guided needle aspiration and antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Non-Surgical Management Rate
Complete clinical and sonographic resolution of the breast abscess without the necessity of formal surgical incision and drainage during the index episode.
Measured: Up to 4 weeks post-treatment
Secondary outcomes (4)
Time to Complete Resolution
Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Measured: Up to 4 weeks
Number of Aspiration Sessions
Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Measured: Up to 4 weeks
Rate of Treatment Failure Requiring Surgical Intervention
Percentage of patients who failed non-surgical management and required formal surgical incision and drainage.
Measured: Up to 4 weeks
Rate of Procedure-Related Complications
Incidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsawy Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777783
- Sponsor's protocol ID
- Soh-Med-26-7-12MS
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Non-Surgical Treatment of Breast Abscess
- ClinicalTrials.gov ID
- NCT07777783
- Acronym / sponsor ID
- Soh-Med-26-7-12MS
- Conditions
- Breast Abscess
- Keywords
- Ultrasound-guided aspiration, Non-surgical treatment, Needle aspiration, Mastitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Aug 2026 (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 abscess is a localized suppurative complication of breast infection commonly managed by ultrasound-guided needle aspiration combined with antibiotic therapy. This prospective observational study aims to evaluate the clinical outcomes and prognostic factors associated with successful non-surgical management versus treatment failure requiring surgical intervention in adult female patients with lactational and non-lactational breast abscesses.
Detailed description
Breast abscess represents a severe complication of mastitis encountered in lactating and non-lactating women. While traditional management relied on incision and drainage, modern approaches emphasize minimally invasive non-surgical treatment using ultrasound-guided needle aspiration combined with appropriate antibiotics to minimize morbidity, accelerate healing, avoid fistula formation, and preserve breastfeeding. This prospective observational study will be conducted at the Department of General Surgery, Sohag University Hospitals. Eligible female patients presenting with lactational or non-lactational breast abscesses will undergo initial non-surgical treatment with ultrasound-guided needle aspiration/re-aspiration with or without catheter drainage plus culture-guided antibiotic therapy. Patients will be followed up clinically and sonographically for 4 weeks to evaluate treatment success, time to resolution, complication rates, and predictors associated with treatment failure requiring surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Treatment Cohort | – | Procedure: Ultrasound-guided needle aspiration and antibioticsAdult female patients presenting with lactational or non-lactational breast abscess undergoing initial non-surgical management via ultrasound-guided needle aspiration with or without catheter drainage plus systemic antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients presenting with lactational or non-lactational breast abscesses eligible for non-surgical care at the General Surgery outpatient clinic or emergency unit at Sohag University Hospitals.
Key inclusion criteria (2 listed)
- Adult female patients diagnosed with lactational and non-lactational breast abscesses on clinical and sonographic grounds.
- Patients undergoing initial non-surgical treatment in the form of ultrasound-guided aspiration/re-aspiration with or without catheter drainage plus systemic antibiotics.
Key exclusion criteria (5 listed)
- Suspicion of inflammatory breast cancer or underlying breast malignancy.
- Frank skin necrosis, thinning, or ruptured abscess overlying the affected breast.
- Patients with breast implants in situ on the affected side.
- History of breast surgery within 90 days of presentation.
- Chronic or recurrent breast abscesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided needle aspiration and antibioticsUltrasound-guided needle aspiration of the abscess cavity (repeated every 2-3 days if residual collection persists) with or without catheter drainage, combined with systemic empirical and culture-sensitive antibiotic therapy. | Procedure or surgery | Non-Surgical Treatment Cohort |
Primary outcome
Successful Non-Surgical Management Rate
Time frame: Up to 4 weeks post-treatment
Complete clinical and sonographic resolution of the breast abscess without the necessity of formal surgical incision and drainage during the index episode.
4 secondary outcomes
Time to Complete Resolution
Time frame: Up to 4 weeks
Number of Aspiration Sessions
Time frame: Up to 4 weeks
Rate of Treatment Failure Requiring Surgical Intervention
Time frame: Up to 4 weeks
Rate of Procedure-Related Complications
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site 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 Sohag University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Non-Surgical Management Rate (time frame: Up to 4 weeks post-treatment). 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 20 Aug 2026.