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Comparison of Standard Incision and Drainage Versus Percutaneous Suction Drainage in the Management of Acute Breast Abscess

A Comparative Study of Management of Acute /Pyogenic Breast Abscess Using Standard Incision and Drainage Versus Percutaneous Suction Drainage

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07588412
Acronym
I&D VS PSD
Enrollment
80
Registered
2026-05-14
Start date
2025-05-15
Completion date
2026-02-15
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Breast Abscess

Keywords

Acute breast abscess, Percutaneous suction drain, Incision and drainage

Brief summary

This prospective interventional study compares the effectiveness of standard incision and drainage versus percutaneous suction drain placement in the management of acute pyogenic breast abscess. Eighty patients were enrolled and allocated equally into two groups. The study evaluates outcomes including postoperative pain, duration of hospital stay, wound healing time, number of dressings required, complications, and recurrence. The aim is to determine whether percutaneous suction drainage provides superior clinical outcomes compared to conventional surgical management.

Detailed description

Acute breast abscess is a common surgical condition requiring prompt intervention. Conventional incision and drainage (I&D) has been the standard treatment; however, it is associated with increased pain, prolonged healing, and frequent dressings. Minimally invasive techniques such as percutaneous suction drainage (PSD) have emerged as alternatives with potential advantages. This prospective comparative interventional study was conducted at GSVM Medical College, Kanpur, from May 2025 to Feb 2026. Eighty patients diagnosed with acute pyogenic breast abscess were allocated into two groups: Group A (I&D) and Group B (PSD). Outcomes assessed included postoperative pain (VAS score), duration of hospital stay, wound healing time, number of dressings, complications (residual abscess, fistula), and recurrence at 3 months. The study aims to compare the efficacy and safety of both treatment modalities.

Interventions

Standard surgical incision and drainage of breast abscess with evacuation of pus.

PROCEDUREPercutaneous Suction Drain

Minimally invasive placement of suction catheter for drainage of breast abscess.

Sponsors

GSVM Medical College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This was an open-label study with no blinding of participants or investigators.

Intervention model description

Participants were allocated into two groups: incision and drainage and percutaneous suction drainage using an odd-even allocation method.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with acute pyogenic breast abscess * Abscess size ≥ 3 cm on ultrasonography * Willing to participate and provide written informed consent

Exclusion criteria

* Abscess size \< 3 cm on ultrasonography * Patients unwilling to provide informed consent * Pre-existing skin disorders involving the breast * Significant comorbid conditions (e.g., coagulopathy, diabetes mellitus, HIV infection, hepatitis B or C) * Diagnosed cases of antibioma * Tuberculous mastitis * Breast malignancy

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painDay 1, 3, 7, 14, 30, 60, and 90 post procedurePostoperative pain will be assessed using the Visual Analog Scale (VAS), a patient-reported pain assessment scale ranging from 0 to 10, where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain severity. Pain scores will be recorded on postoperative Day 1, Day 3, Day 7, Day 14, Day 30, Day 60, and Day 90 after the procedure.
Number of DressingsWithin 30 days post-procedureTotal number of postoperative dressings required per patient in number
Length of HospitalizationUp to 15 days post-procedureLength of hospital stay measured in days from procedure to discharge
Wound healingFrom procedure to complete wound healing (up to 30 days)Time to complete wound healing, defined as the number of days from the procedure to full epithelialization of the wound with absence of discharge, assessed by clinical examination.

Secondary

MeasureTime frameDescription
Residual AbscessWithin 30 days post-procedureIncidence of residual abscess, defined as the presence of a persistent or recurrent fluid collection at the original site confirmed by clinical examination and/or ultrasonography after the initial procedure.
FISTULA FORMATIONWithin 30 days post-procedureIncidence of fistula formation, defined as the development of a persistent abnormal tract with discharge from the wound site following the procedure, confirmed by clinical examination.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026