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Not yet recruitingNCT06575049Updated Sep 19, 2024

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

An observational study in Breast Cancer, Post-Operative Hematoma and Seroma as Procedural Complication, sponsored by Seoul National University Hospital. Not yet recruiting. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Post-Operative Hematoma
  • Seroma as Procedural Complication
  • Post-Op Complication
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Among patients who underwent breast cancer surgery at Seoul National University Hospital from January 1, 2023 to December 31, 2023, 127 patients were prescribed ketorolac and wore compression dressings. The number of patients was calculated to be approximately 60 to collect basic data to confirm the feasibility of conducting the main study.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • MAXIGESIC

    Maxigesig group

  • Ketololac

    ketololac group

05

What researchers measure

Primary outcomes

  1. Postoperative hemovac or JP total drainage amount

    Postoperative hemovac or JP total drainage amount

    Time frame: within 3 months

  2. hematoma incidence

    hematoma incidence

    Time frame: within 3 months

  3. Seroma incidence

    Seroma incidence

    Time frame: within 3 months

Secondary outcomes

  1. Length of hospital stay

    Length of hospital stay and re operation rate

    Time frame: within 3 months

  2. Complication

    * 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

    Time frame: within 3 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06575049
Lead sponsor
Seoul National University Hospital
Responsible party
Hyeong-Gon Moon (PF., Seoul National University Hospital) — Principal investigator
First posted
Aug 28, 2024
Start date
May 1, 2025 (estimated)
Primary completion
Aug 30, 2025 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

JIN YOUNG BYEON
Contact
jyb.gsb@gmail.com
0220721563

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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