Comparison of Standard Incision and Drainage Versus Percutaneous Suction Drainage in the Management of Acute Breast Abscess (I&D VS PSD)

A Comparative Study of Management of Acute /Pyogenic Breast Abscess Using Standard Incision and Drainage Versus Percutaneous Suction Drainage

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.

Study Overview

• Status: Completed
• Conditions: Acute Breast Abscess
• Intervention / Treatment: Procedure: Incision and Drainage; Procedure: Percutaneous Suction Drain

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • Gsvm Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incision and Drainage; Standard surgical incision and drainage of breast abscess	Procedure: Incision and Drainage; Standard surgical incision and drainage of breast abscess with evacuation of pus.
Experimental: Percutaneous Suction Drain; Minimally invasive suction drain placement for breast abscess	Procedure: Percutaneous Suction Drain; Minimally invasive placement of suction catheter for drainage of breast abscess.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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.	Day 1, 3, 7, 14, 30, 60, and 90 post procedure
Number of Dressings	Total number of postoperative dressings required per patient in number	Within 30 days post-procedure
Length of Hospitalization	Length of hospital stay measured in days from procedure to discharge	Up to 15 days post-procedure
Wound healing	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.	From procedure to complete wound healing (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Abscess	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.	Within 30 days post-procedure
FISTULA FORMATION	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.	Within 30 days post-procedure

Collaborators and Investigators

• Sponsor: GSVM Medical College

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Incision and drainage; Acute breast abscess; Percutaneous suction drain
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: GSVMC-INT-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional policy and patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No