Comparison of Multiple Percutaneous Needle Aspiration Versus Incision and Drainage in Small Breast Abscesses: Pain, Cosmesis, and Early Breastfeeding Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Abscess
• Intervention / Treatment: Procedure: Multiple Percutaneous Needle Aspiration (MPNA); Procedure: Incision and Drainage (ID)

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Bahawalpur, Punjab, Pakistan, 63100
      • Bahawal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Percutaneous Needle Aspiration (MPNA) Group; Participants in this group underwent multiple percutaneous needle aspiration for the treatment of small breast abscesses	Procedure: Multiple Percutaneous Needle Aspiration (MPNA); A minimally invasive technique involving repeated needle aspiration of breast abscess fluid without making an incision.; Procedure: Incision and Drainage (ID); A surgical procedure involving an incision in the abscess to allow drainage of pus, followed by wound care.
Active Comparator: Incision and Drainage (ID) Group; Participants in this group underwent incision and drainage for the treatment of small breast abscesses.	Procedure: Multiple Percutaneous Needle Aspiration (MPNA); A minimally invasive technique involving repeated needle aspiration of breast abscess fluid without making an incision.; Procedure: Incision and Drainage (ID); A surgical procedure involving an incision in the abscess to allow drainage of pus, followed by wound care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Assessment of pain using a standardized visual analog scale (VAS) at 1 week after the procedure.	1 week post-procedure
Breastfeeding Restoration	Proportion of patients resuming breastfeeding at 1 month after intervention, determined by patient self-report.	1 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Satisfaction	Patient-reported satisfaction with cosmetic outcomes, assessed through a survey at 1 month after intervention.	1 month post-procedure

Collaborators and Investigators

• Sponsor: Quaid-e-Azam Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2021
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: No. PG656/DME/QAMC/BWP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No