A Comparative Study of Management of Acute /Pyogenic Breast Abscess Using Standard Incision and Drainage Versus Percutaneous Suction Drainage
| Registry | NCT07588412, acronym I&D VS PSD |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 80 (Actual) |
| Sponsor | GSVM Medical College (Other) |
| Conditions | Acute Breast Abscess |
| Interventions | Incision and Drainage, Percutaneous Suction Drain (Procedure) |
| Dates | start 2025-05-15, primary completion 2026-02-15, completion 2026-02-15, first posted 2026-05-14, last updated 2026-05-14 |
| Locations | 1 site in India |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Breast Abscess All trials of Incision and Drainage All trials of Percutaneous Suction Drain
-Summary
This prospective interventional study compares the effectiveness of standard incision and drainage versus percutaneous suction drain placement in the management of acute pyogenic breast abscess. Eighty patients were enrolled and allocated equally into two groups. The study evaluates outcomes including postoperative pain, duration of hospital stay, wound healing time, number of dressings required, complications, and recurrence. The aim is to determine whether percutaneous suction drainage provides superior clinical outcomes compared to conventional surgical management.
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+Detailed description
Acute breast abscess is a common surgical condition requiring prompt intervention. Conventional incision and drainage (I\&D) has been the standard treatment; however, it is associated with increased pain, prolonged healing, and frequent dressings. Minimally invasive techniques such as percutaneous suction drainage (PSD) have emerged as alternatives with potential advantages.
This prospective comparative interventional study was conducted at GSVM Medical College, Kanpur, from May 2025 to Feb 2026. Eighty patients diagnosed with acute pyogenic breast abscess were allocated into two groups: Group A (I\&D) and Group B (PSD).
Outcomes assessed included postoperative pain (VAS score), duration of hospital stay, wound healing time, number of dressings, complications (residual abscess, fistula), and recurrence at 3 months. The study aims to compare the efficacy and safety of both treatment modalities.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Incision and Drainage | Experimental | Procedure: Incision and Drainage | Standard surgical incision and drainage of breast abscess |
| Percutaneous Suction Drain | Experimental | Procedure: Percutaneous Suction Drain | Minimally invasive suction drain placement for breast abscess |
- Incision and Drainage (Procedure): Standard surgical incision and drainage of breast abscess with evacuation of pus.
- Percutaneous Suction Drain (Procedure): Minimally invasive placement of suction catheter for drainage of breast abscess.
+Outcome measures
Primary outcomes
- Postoperative pain [Day 1, 3, 7, 14, 30, 60, and 90 post procedure]: Postoperative pain will be assessed using the Visual Analog Scale (VAS), a patient-reported pain assessment scale ranging from 0 to 10, where:
0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain severity. Pain scores will be recorded on postoperative Day 1, Day 3, Day 7, Day 14, Day 30, Day 60, and Day 90 after the procedure.
- Number of Dressings [Within 30 days post-procedure]: Total number of postoperative dressings required per patient in number
- Length of Hospitalization [Up to 15 days post-procedure]: Length of hospital stay measured in days from procedure to discharge
- Wound healing [From procedure to complete wound healing (up to 30 days)]: Time to complete wound healing, defined as the number of days from the procedure to full epithelialization of the wound with absence of discharge, assessed by clinical examination.
Secondary outcomes
- Residual Abscess [Within 30 days post-procedure]: Incidence of residual abscess, defined as the presence of a persistent or recurrent fluid collection at the original site confirmed by clinical examination and/or ultrasonography after the initial procedure.
- FISTULA FORMATION [Within 30 days post-procedure]: Incidence of fistula formation, defined as the development of a persistent abnormal tract with discharge from the wound site following the procedure, confirmed by clinical examination.
+Eligibility
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria:
* Patients diagnosed with acute pyogenic breast abscess
* Abscess size ≥ 3 cm on ultrasonography
* Willing to participate and provide written informed consent
Exclusion Criteria:
* Abscess size < 3 cm on ultrasonography
* Patients unwilling to provide informed consent
* Pre-existing skin disorders involving the breast
* Significant comorbid conditions (e.g., coagulopathy, diabetes mellitus, HIV infection, hepatitis B or C)
* Diagnosed cases of antibioma
* Tuberculous mastitis
* Breast malignancy
+Locations (1)
| Facility | City | Country | Status |
|---|
| Gsvm Medical College | Kanpur, Uttar Pradesh | India | |
+Publications
- Hassan SSU et al. (2024). Comparative study on recurrence rates: incision and drainage versus percutaneous aspiration in breast abscess. DOI: 10.54112/bcsir.v2024i1.783
- Prashanth C et al. (2024). Institutional comparative study: ultrasound-guided needle aspiration versus incision and drainage in 50 patients-success, healing, recurrence. DOI: 10.18203/2349-2902.isj20241308
- Khan MH et al. (2023). Prospective comparative study: percutaneous needle aspiration versus conventional incision and drainage in 120 breast abscess patients. DOI: 10.53350/pjmhs020231712516
- Singh SP et al. (2022). Extended cohort analysis: open incision and drainage versus ultrasound-guided minimally invasive procedures in breast abscess. DOI: 10.53730/ijhs.v6nS2.6001
- Singh SP et al. (2022). Prospective cohort study: incision and drainage versus ultrasound-guided minimally invasive drainage-healing, complications, recurrence. DOI: 10.53730/ijhs.v6nS1.5857
- Reddy KS et al. (2022). Clinical comparison of incision and drainage versus percutaneous suction drainage: healing, hospital stay, and scar quality. DOI: 10.33545/surgery.2022.v6.i3a.913
- Chorma A et al. (2022). Comparative three-arm investigation: conventional incision and drainage versus percutaneous suction drainage versus ultrasound-guided aspiration. DOI: 10.22159/ajpcr.2022.v15i11.45696
- Ali MN et al. (2020). Clinical study: ultrasound-guided needle aspiration versus surgical incision and drainage-outcomes and patient selection. DOI: 10.3329/taj.v33i1.49817
- Dayal P et al. (2019). Prospective randomized controlled trial: ultrasound-guided needle aspiration versus conventional incision and drainage in 100 patients with breast abscess. DOI: 10.32553/ijmbs.v3i4.201
- Kataria R et al. (2019). Randomized controlled trial: ultrasound-guided needle aspiration versus suction catheter drainage for breast abscess. DOI: 10.18203/2349-2902.isj20193682
- Oditya S et al. Comparative clinical study of conventional incision and drainage versus percutaneous suction catheter drainage in puerperal breast abscess. 2016. DOI: 10.18203/2349-2902.isj20162751