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CompletedNCT06951373Updated Apr 30, 2025

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

An interventional study of Multiple Percutaneous Needle Aspiration (MPNA) and Incision and Drainage (ID) in Breast Abscess, sponsored by Quaid-e-Azam Medical College. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Quaid-e-Azam Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Jan 2021, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Breast Abscess

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03

In context

Abscess

152 studies on the registry are indexed under Abscess; 22 are open to participants now.

This study's enrollment of 110 is close to the median of 110 across 120 interventional studies indexed under Abscess.

Browse Abscess studies →

Lead sponsor

Quaid-e-Azam Medical College is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • 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) · Procedure: Incision and Drainage (ID)

  • 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) · Procedure: Incision and Drainage (ID)

Interventions

  • ProcedureMultiple Percutaneous Needle Aspiration (MPNA)

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

  • ProcedureIncision and Drainage (ID)

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

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What researchers measure

Primary outcomes

  1. Pain Score

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

    Time frame: 1 week post-procedure

  2. Breastfeeding Restoration

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

    Time frame: 1 month post-procedure

Secondary outcomes

  1. Cosmetic Satisfaction

    Patient-reported satisfaction with cosmetic outcomes, assessed through a survey at 1 month after intervention.

    Time frame: 1 month post-procedure

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Study locations

1 site
  • Bahawal Victoria Hospital
    Bahawalpur, Punjab 63100, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Jun 2021, 4 months.

Of 21 interventional studies with no phase under Abscess, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
Apr 30, 2025
StartActual
Jan 9, 2021
Primary completionActual
Jun 8, 2021
CompletionActual
Jun 8, 2021
Last update
Apr 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06951373
Lead sponsor
Quaid-e-Azam Medical College
Responsible party
Aroona Arif (Postgraduate Resident, Quaid-e-Azam Medical College) — Principal investigator
First posted
Apr 30, 2025
Start date
Jan 9, 2021
Primary completion
Jun 8, 2021
Completion
Jun 8, 2021
Last update
Apr 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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