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

NCT ID: NCT06951373

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-09
• Study Completion Date: 2021-06-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multiple Percutaneous Needle Aspiration (MPNA) Group

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

Group Type: EXPERIMENTAL

Multiple Percutaneous Needle Aspiration (MPNA)

Intervention Type: PROCEDURE

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

Incision and Drainage (ID)

Intervention Type: PROCEDURE

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

Incision and Drainage (ID) Group

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

Group Type: ACTIVE_COMPARATOR

Multiple Percutaneous Needle Aspiration (MPNA)

Intervention Type: PROCEDURE

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

Incision and Drainage (ID)

Intervention Type: PROCEDURE

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

Interventions

Multiple Percutaneous Needle Aspiration (MPNA)

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

Intervention Type: PROCEDURE

Incision and Drainage (ID)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Quaid-e-Azam Medical College

OTHER

Sponsor Role: lead

Responsible Party

Aroona Arif

Postgraduate Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

No. PG656/DME/QAMC/BWP

Identifier Type: -

Identifier Source: org_study_id