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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06575049
Enrollment
60
Registered
2024-08-28
Start date
2025-05-01
Completion date
2026-02-20
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Post-Op Complication, Post-Operative Hematoma, Seroma as Procedural Complication

Brief summary

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative hemovac or JP total drainage amountwithin 3 monthsPostoperative hemovac or JP total drainage amount
hematoma incidencewithin 3 monthshematoma incidence
Seroma incidencewithin 3 monthsSeroma incidence

Secondary

MeasureTime frameDescription
Length of hospital staywithin 3 monthsLength of hospital stay and re operation rate
Complicationwithin 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

Contacts

Primary ContactJIN YOUNG BYEON
jyb.gsb@gmail.com0220721563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026