Breast AbscessNCT06951373
Comparison of Multiple Percutaneous Needle Aspiration Versus Incision and Drainage in Small Breast Abscesses: Pain, Cosmesis, and Early Breastfeeding Outcomes
A study testing Multiple Percutaneous Needle Aspiration (MPNA) and Incision and Drainage (ID) in people with Breast Abscess, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Abscess
- What is being tested?
- Multiple Percutaneous Needle Aspiration (MPNA) and Incision and Drainage (ID)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jan 2021to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Married breastfeeding women Age: 18-45 years Diagnosed with breast abscess (≤5 cm in diameter)
Who cannot join
- Complicated abscesses Compromised immune system History of prior surgical interventions for breast abscess Unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Abscess
- Being tested
- Multiple Percutaneous Needle Aspiration (MPNA), Incision and Drainage (ID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Percutaneous Needle Aspiration (MPNA)Procedure or surgery
A minimally invasive technique involving repeated needle aspiration of breast abscess fluid without making an incision.
Incision and Drainage (ID)Procedure or surgery
A surgical procedure involving an incision in the abscess to allow drainage of pus, followed by wound care.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Percutaneous Needle Aspiration (MPNA) Group | Experimental | Participants in this group underwent multiple percutaneous needle aspiration for the treatment of small breast abscesses Receives: 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. Receives: Procedure: Multiple Percutaneous Needle Aspiration (MPNA); Procedure: Incision and Drainage (ID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Assessment of pain using a standardized visual analog scale (VAS) at 1 week after the procedure.
Measured: 1 week post-procedure
Breastfeeding Restoration
Proportion of patients resuming breastfeeding at 1 month after intervention, determined by patient self-report.
Measured: 1 month post-procedure
Secondary outcomes (1)
Cosmetic Satisfaction
Patient-reported satisfaction with cosmetic outcomes, assessed through a survey at 1 month after intervention.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start9 Jan 2021
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aroona Arif, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951373
- Sponsor's protocol ID
- No. PG656/DME/QAMC/BWP
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain, Cosmesis and Early Restoration of Breast Feeding in Multiple Percutaneous Needle Aspiration Vs Incision and Drainage for Small Breast Abscess Management
- ClinicalTrials.gov ID
- NCT06951373
- Acronym / sponsor ID
- No. PG656/DME/QAMC/BWP
- Conditions
- Breast Abscess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Percutaneous Needle Aspiration (MPNA) Group | Experimental | Procedure: Multiple Percutaneous Needle Aspiration (MPNA), Procedure: Incision and Drainage (ID)Participants in this group underwent multiple percutaneous needle aspiration for the treatment of small breast abscesses |
| Incision and Drainage (ID) Group | Active comparator | Procedure: Multiple Percutaneous Needle Aspiration (MPNA), Procedure: Incision and Drainage (ID)Participants in this group underwent incision and drainage for the treatment of small breast abscesses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Married breastfeeding women Age: 18-45 years Diagnosed with breast abscess (≤5 cm in diameter)
Key exclusion criteria (1 listed)
- Complicated abscesses Compromised immune system History of prior surgical interventions for breast abscess Unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Percutaneous Needle Aspiration (MPNA)A minimally invasive technique involving repeated needle aspiration of breast abscess fluid without making an incision. | Procedure or surgery | Incision and Drainage (ID) Group, Multiple Percutaneous Needle Aspiration (MPNA) Group |
| Incision and Drainage (ID)A surgical procedure involving an incision in the abscess to allow drainage of pus, followed by wound care. | Procedure or surgery | Incision and Drainage (ID) Group, Multiple Percutaneous Needle Aspiration (MPNA) Group |
Primary outcome
Pain Score
Time frame: 1 week post-procedure
Assessment of pain using a standardized visual analog scale (VAS) at 1 week after the procedure.
Breastfeeding Restoration
Time frame: 1 month post-procedure
Proportion of patients resuming breastfeeding at 1 month after intervention, determined by patient self-report.
1 secondary outcome
Cosmetic Satisfaction
Time frame: 1 month post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Percutaneous Needle Aspiration (MPNA) and Incision and Drainage (ID) in people with Breast Abscess, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 1 week post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.