Evaluation of Non-Surgical Treatment of Breast Abscess
ConditionBreast Abscess
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSohag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-guided needle aspiration and antibiotics
Procedure/SurgeryUltrasound-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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Non-Surgical Treatment Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 4 weeks post-treatmentSecondary outcomes
1
Time to Complete Resolution
Duration in days required from initiation of treatment until complete clinical and ultrasonographic resolution.
Time frame
Up to 4 weeks2
Number of Aspiration Sessions
Total number of ultrasound-guided needle aspiration sessions performed to achieve complete resolution.
Time frame
Up to 4 weeks3
Rate of Treatment Failure Requiring Surgical Intervention
Percentage of patients who failed non-surgical management and required formal surgical incision and drainage.
Time frame
Up to 4 weeks4
Rate of Procedure-Related Complications
Incidence of complications related to treatment such as skin necrosis, breast fistula formation, and galactocele.
Time frame
Up to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov