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

NCT06951373 | Completed

• 1 other identifier: No. PG656/DME/QAMC/BWP
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Abscess

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cosmetic Satisfaction

  1 month post-procedure

Study Arms (2)

Multiple Percutaneous Needle Aspiration (MPNA) Group

EXPERIMENTAL

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

Procedure: Multiple Percutaneous Needle Aspiration (MPNA); Procedure: Incision and Drainage (ID)

Incision and Drainage (ID) Group

ACTIVE COMPARATOR

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

Procedure: Multiple Percutaneous Needle Aspiration (MPNA); Procedure: Incision and Drainage (ID)

Interventions

Multiple Percutaneous Needle Aspiration (MPNA) PROCEDURE

A minimally invasive technique involving repeated needle aspiration of breast abscess fluid without making an incision.

Incision and Drainage (ID) Group; Multiple Percutaneous Needle Aspiration (MPNA) Group

Incision and Drainage (ID) PROCEDURE

A surgical procedure involving an incision in the abscess to allow drainage of pus, followed by wound care.

Incision and Drainage (ID) Group; Multiple Percutaneous Needle Aspiration (MPNA) Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Quaid-e-Azam Medical College: lead

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 30, 2025
• Study Start: January 9, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)