Breast cancer.
Conditions
Interventions
Intervention 1: Intervention group: Patients undergoing breast-conserving surgery (lumpectomy) for breast cancer, followed by intraoperative application of helium-based cold atmospheric plasma (CAP) j
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Female patients Patients who haven't received neoadjuvant chemotherapy Patients who are not under 20 years old or over 65 years old Patients who haven't undergone a modified radical mastectomy (MRM) Patients who aren't received antibiotic treatment for active infection
Exclusion criteria
Exclusion criteria: Patients under 20 years old or over 65 years old Male patients Patients who have received neoadjuvant chemotherapy Patients who have undergone a modified radical mastectomy (MRM) Patients who are receiving antibiotic treatment for active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of local recurrence of breast cancer over a 5-year follow-up period. Timepoint: The primary outcome is assessed over a 5-year follow-up period post-surgery. Patients are monitored for local recurrence with intensive follow-up in the first 2 years (clinical examinations every 6 months) followed by annual follow-up thereafter (clinical examinations, mammography, and ultrasonography annually, with biopsy if suspicious findings arise). Method of measurement: Local recurrence is measured by periodic clinical examinations (including palpation for new masses, skin changes, redness, tenderness, or firmness in the operated area), imaging studies (annual mammography and ultrasonography, with more frequent imaging if needed), and histopathological confirmation via tissue biopsy for any suspicious findings. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf.Mohamad Esmaeil Akbari
Shahid Beheshti University of Medical Sciences
Outcome results
None listed