A Comparative Study of Management of Acute /Pyogenic Breast Abscess Using Standard Incision and Drainage Versus Percutaneous Suction Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label study with no blinding of participants or investigators.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with acute pyogenic breast abscess
- •Abscess size ≥ 3 cm on ultrasonography
- •Willing to participate and provide written informed consent
排除标准
- •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
研究组 & 干预措施
Incision and Drainage
Standard surgical incision and drainage of breast abscess
干预措施: Incision and Drainage (Procedure)
Percutaneous Suction Drain
Minimally invasive suction drain placement for breast abscess
干预措施: Percutaneous Suction Drain (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 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.
Number of Dressings
时间窗: Within 30 days post-procedure
Total number of postoperative dressings required per patient in number
Length of Hospitalization
时间窗: Up to 15 days post-procedure
Length of hospital stay measured in days from procedure to discharge
Wound healing
时间窗: 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.
次要结局
- Residual Abscess(Within 30 days post-procedure)
- FISTULA FORMATION(Within 30 days post-procedure)
研究者
HARI KRISHNA GUPTA
Postgraduate Resident
GSVM Medical College