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

ConditionsBreast CancerPost-Operative HematomaSeroma as Procedural ComplicationPost-Op Complication
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-70
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: MAXIGESIC
Group B: Ketololac

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: