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

10. mai 2026 oppdatert av: HARI KRISHNA GUPTA, GSVM Medical College

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Incision and Drainage
Standard surgical incision and drainage of breast abscess
Fremgangsmåte: Incision and Drainage
Standard surgical incision and drainage of breast abscess with evacuation of pus.
Eksperimentell: Percutaneous Suction Drain
Minimally invasive suction drain placement for breast abscess
Fremgangsmåte: Percutaneous Suction Drain
Minimally invasive placement of suction catheter for drainage of breast abscess.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Residual Abscess
Tidsramme: 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.
Within 30 days post-procedure
FISTULA FORMATION
Tidsramme: 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.
Within 30 days post-procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GSVM Medical College

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mai 2025

Primær fullføring (Faktiske)

15. februar 2026

Studiet fullført (Faktiske)

15. februar 2026

Datoer for studieregistrering

Først innsendt

4. april 2026

Først innsendt som oppfylte QC-kriteriene

10. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GSVMC-INT-2024-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to institutional policy and patient confidentiality.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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