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临床试验/NCT06951373
NCT06951373已完成不适用

Comparison of Pain, Cosmesis and Early Restoration of Breast Feeding in Multiple Percutaneous Needle Aspiration Vs Incision and Drainage for Small Breast Abscess Management

Quaid-e-Azam Medical College1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Pain Score

研究概览

简要总结

This study aims to compare the effectiveness of multiple percutaneous needle aspiration (MPNA) versus incision and drainage (ID) for the management of small breast abscesses in breastfeeding women. The trial evaluates three key outcomes: post-procedure pain levels, cosmetic satisfaction, and the timing of breastfeeding restoration. The study is conducted at the Department of Surgery, Bahawal Victoria Hospital Bahawalpur, enrolling 110 lactating women aged 18-45 years with abscesses ≤5 cm in diameter. Participants were treated with either MPNA or ID based on clinical decision and patient preference. Pain levels were assessed using a standardized scale, cosmetic outcomes were evaluated via patient-reported satisfaction, and breastfeeding restoration was monitored at baseline, one week, and one month post-treatment. Findings indicate that MPNA is associated with lower pain scores, better cosmetic satisfaction, and faster resumption of breastfeeding compared to ID, suggesting MPNA as a preferred first-line treatment for small breast abscesses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Married breastfeeding women Age: 18-45 years Diagnosed with breast abscess (≤5 cm in diameter)

排除标准

  • •Complicated abscesses Compromised immune system History of prior surgical interventions for breast abscess Unwilling to participate in the study

研究组 & 干预措施

Multiple Percutaneous Needle Aspiration (MPNA) Group

Experimental

Participants in this group underwent multiple percutaneous needle aspiration for the treatment of small breast abscesses

干预措施: Incision and Drainage (ID) (Procedure)

Multiple Percutaneous Needle Aspiration (MPNA) Group

Experimental

Participants in this group underwent multiple percutaneous needle aspiration for the treatment of small breast abscesses

干预措施: Multiple Percutaneous Needle Aspiration (MPNA) (Procedure)

Incision and Drainage (ID) Group

Active Comparator

Participants in this group underwent incision and drainage for the treatment of small breast abscesses.

干预措施: Multiple Percutaneous Needle Aspiration (MPNA) (Procedure)

Incision and Drainage (ID) Group

Active Comparator

Participants in this group underwent incision and drainage for the treatment of small breast abscesses.

干预措施: Incision and Drainage (ID) (Procedure)

结局指标

主要结局

Pain Score

时间窗: 1 week post-procedure

Assessment of pain using a standardized visual analog scale (VAS) at 1 week after the procedure.

Breastfeeding Restoration

时间窗: 1 month post-procedure

Proportion of patients resuming breastfeeding at 1 month after intervention, determined by patient self-report.

次要结局

  • Cosmetic Satisfaction(1 month post-procedure)

研究者

发起方
Quaid-e-Azam Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aroona Arif

Postgraduate Resident

Quaid-e-Azam Medical College

研究点 (1)

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