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

NCT06575049 | Not Yet Recruiting DMC

• 1 other identifier: 2312-168-1498
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Postoperative hemovac or JP total drainage amount

  Postoperative hemovac or JP total drainage amount

  within 3 months

• hematoma incidence

  hematoma incidence

  within 3 months

• Seroma incidence

  Seroma incidence

  within 3 months

Secondary Outcomes (2)

• Length of hospital stay

  within 3 months

• Complication

  within 3 months

Study Arms (2)

MAXIGESIC

Maxigesig group

Ketololac

ketololac group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

JIN YOUNG BYEON

CONTACT

0220721563; jyb.gsb@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PF.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: May 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: February 20, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09