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

August 26, 2024 updated by: Hyeong-Gon Moon, Seoul National University Hospital

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

We 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. We 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Maxigesic
Maxigesic(1000mg/300mg/100mL acetaminophen/ibuprofen iv)
Ketololac
ketorolac(30mg/1mL iv)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hemovac or JP total drainage amount
Time Frame: within 3 months
Postoperative hemovac or JP total drainage amount
within 3 months
hematoma incidence
Time Frame: within 3 months
hematoma incidence
within 3 months
Seroma incidence
Time Frame: within 3 months
Seroma incidence
within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: within 3 months
Length of hospital stay and re operation rate
within 3 months
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
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2312-168-1498

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe