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NCT Number: NCT06575049

Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery

The investigators aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. The investigators seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Post-Operative Hematoma Postoperative Complications Seroma as Procedural Complication Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemic performance status 0-2 according to ECOG criteria
  • Patients with adequate renal function: serum Cr 1.4 mg/dL or less
  • Patients with adequate liver function Bilirubin, AST/ALT: 1.5 times or less of the upper limit of normal, Alkaline phosphatase: 1.8 times or less of the upper limit of normal
  • Patients undergoing total mastectomy with SLNB or ALND (mastectomy and axillary sentinel lymph node dissection)
  • Patients undergoing breast-conserving surgery with ALND (mastectomy and axillary dissection)
  • Patients who voluntarily decided to participate in this study and signed a written informed consent form

Exclusion criteria

  • Patients undergoing immediate reconstruction operation
  • Patients with drug allergies to painkillers and anti-inflammatory drugs
  • Patients with a physical condition that would interfere with understanding and submitting the consent form

Treatment and study plan

Primary outcomes

  1. Postoperative hemovac or JP total drainage amount

    Time frame: within 3 months

    Postoperative hemovac or JP total drainage amount

  2. hematoma incidence

    Time frame: within 3 months

    hematoma incidence

  3. Seroma incidence

    Time frame: within 3 months

    Seroma incidence

Secondary outcomes

  1. Length of hospital stay

    Time frame: within 3 months

    Length of hospital stay and re operation rate

  2. Complication

    Time frame: within 3 months

    • When hematoma occurs: Whether transfusion is required and whether EB band is applied, check the amount when aspirating (diagnosis criteria color: sanguinous, old bloody [brownish], operation (hematoma evacuation)
    • When seroma occurs: check the amount when aspirating (diagnosis criteria color: serous, serosanguinous)
    • Complication: Whether abscess occurs

Study contacts

Contact information is provided by the study sponsor or research team.

JIN YOUNG BYEON

CONTACT

[email protected]

0220721563

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparative Analysis of Seroma and Hematoma Rates: MAXIGESIC vs. Ketorolac in Breast Cancer Surgery Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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