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NCT Number: NCT07588412

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

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.

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Key information

Conditions

Acute Breast Abscess Surgical Wound Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gsvm Medical College

Kanpur, Uttar Pradesh, 208002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incision and Drainage

Procedure

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

Percutaneous Suction Drain

Procedure

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

Primary outcomes

  1. Postoperative pain

    Time frame: Day 1, 3, 7, 14, 30, 60, and 90 post procedure

    Postoperative 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.

  2. Number of Dressings

    Time frame: Within 30 days post-procedure

    Total number of postoperative dressings required per patient in number

  3. Length of Hospitalization

    Time frame: Up to 15 days post-procedure

    Length of hospital stay measured in days from procedure to discharge

  4. Wound healing

    Time frame: From 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 outcomes

  1. Residual Abscess

    Time frame: Within 30 days post-procedure

    Incidence 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.

  2. FISTULA FORMATION

    Time frame: Within 30 days post-procedure

    Incidence 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.

Sponsors and collaborators

Lead sponsor

GSVM Medical College

Other

Registry information

Official study title

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

Acronym: I&D VS PSD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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