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A study to compare USG guided Needle Aspiration vs Surgical Drainage in Management of Lactating Breast Abscess

Ultrasonography guided Needle Aspiration Vs Surgical Drainage in Management of Lactating Breast Abscess: A Randomised Controlled Non-Inferiority Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025124
Enrollment
78
Registered
2020-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N611- Abscess of the breast and nipple

Interventions

Intervention1: Ultrasound guided Needle Aspiration of Lactating Breast Abscess: Intervention group will undergo needle aspiration under ultrasound guidance using an 18-gauge needle with 20 cc syringe

Sponsors

Bishal Pal
Lead Sponsor
Dr G Balasubramanian
Collaborator
Dr Uday Shamrao Kumbhar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Lactating Female with breast abscess

Exclusion criteria

Exclusion criteria: 1. Patients with spontaneous rupture of breast abscess 2. Patient with complicated breast abscess [like skin involvement (ulceration, necrosis), multiloculated, suspicious malignancy] and immunosuppression.

Design outcomes

Primary

MeasureTime frame
Failure rate in between two groupsTimepoint: 7th day after procedure

Secondary

MeasureTime frame
Post-operative Pain in between two groupsTimepoint: Pain will be measured by Visual Analogue Score on immediate postoperative period, 24 hrs and 48 hrs post-operative day and if VAS is more than 4 then analgesics will be given;Time to Heal in Surgical Drainage groupTimepoint: For Surgical Drainage group: 1. Time duration will be measured till absence of active purulent discharge from wound site during dressing and, 2. Absence of clinical signs of inflammation and, 3. Normalisation of leucocyte counts (less than 11000 cells / cmm) Assessed on Day 1, Day 3, Day 5, Day 7 after procedure;Time to Heal in USG guided Needle Aspiration groupTimepoint: For USG guided Needle Aspiration group: 1. Time duration in days measured from first aspiration till the day of Ultrasonography finding not suggestive of re-collection or inflammation and, 2. Absence of clinical signs of inflammation and, 3. Normalisation of leucocyte counts (less than 11000 cells / cmm) Assessed on Day 1, Day 3, Day 5, Day 7 after procedure

Countries

India

Contacts

Public ContactDr Uday Shamrao Kumbhar

Jawaharlal Institute of Postgraduate Medical Education and Research

drbala18@gmail.com9894493841

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026