Comparison of Standard Incision and Drainage Versus Percutaneous Suction Drainage in the Management of Acute Breast Abscess

NCT07588412 | Completed

• 1 other identifier: GSVMC-INT-2024-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Breast Abscess

Keywords

Acute breast abscess; Percutaneous suction drain; Incision and drainage

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Residual Abscess

  Within 30 days post-procedure

• FISTULA FORMATION

  Within 30 days post-procedure

Study Arms (2)

Incision and Drainage

EXPERIMENTAL

Standard surgical incision and drainage of breast abscess

Procedure: Incision and Drainage

Percutaneous Suction Drain

EXPERIMENTAL

Minimally invasive suction drain placement for breast abscess

Procedure: Percutaneous Suction Drain

Interventions

Incision and Drainage PROCEDURE

Standard surgical incision and drainage of breast abscess with evacuation of pus.

Incision and Drainage

Percutaneous Suction Drain PROCEDURE

Minimally invasive placement of suction catheter for drainage of breast abscess.

Percutaneous Suction Drain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute pyogenic breast abscess
• Abscess size ≥ 3 cm on ultrasonography
• Willing to participate and provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• GSVM Medical College: lead

Study Sites (1)

Gsvm Medical College

Kanpur, Uttar Pradesh, 208002, India

Location

Related Publications (11)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Interventions

Drainage

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study with no blinding of participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: Participants were allocated into two groups: incision and drainage and percutaneous suction drainage using an odd-even allocation method.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: May 14, 2026
• Study Start: May 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)