Breast CancerNCT06575049
Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery
An observational study of Breast Cancer and Post-Operative Hematoma, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Post-Operative Hematoma, Seroma as Procedural Complication
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 20 Feb 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Analysis of Seroma and Hematoma Rates: MAXIGESIC vs. Ketorolac in Breast Cancer Surgery Patients
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.
- Conditions
- Breast Cancer, Post-Operative Hematoma, Seroma as Procedural Complication, Post-Op Complication
- Medical subject headings
- Breast Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MAXIGESIC | Maxigesig group | |
| Ketololac | ketololac group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hemovac or JP total drainage amount
Postoperative hemovac or JP total drainage amount
Measured: within 3 months
hematoma incidence
hematoma incidence
Measured: within 3 months
Seroma incidence
Seroma incidence
Measured: within 3 months
Secondary outcomes (2)
Length of hospital stay
Length of hospital stay and re operation rate
Measured: within 3 months
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
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 May 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575049
- Sponsor's protocol ID
- 2312-168-1498
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No