Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients (NCT07345026) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
South Korea116 participantsStarted 2026-01-08
Plain-language summary
The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery.
The main questions it aims to answer are:
1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?
2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm?
Researchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups.
Participants will:
* Undergo breast-conserving surgery, with or without SureDerm (assigned randomly)
* Receive standard postoperative radiotherapy
* Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery
* Be followed for complications and cosmetic assessments by physicians
Who can participate
Age range
20 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 20 to 75 years
* Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery
* Agreed to the use of acellular dermal matrix (ADM) during surgery
* Histologically confirmed primary breast cancer
* Patients who received neoadjuvant chemotherapy are eligible
* Planned to receive standard postoperative treatment, including adjuvant radiotherapy
* Voluntarily decided to participate in the study and provided written informed consent
Exclusion Criteria:
* Evidence of distant metastasis
* Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding/coagulation disorders
* Known adverse reactions to all first-line antibiotics
* Suspected inflammatory infection of the breast prior to surgery
* Pregnant women at the time of enrollment
* Definite contraindications to the use of acellular dermal matrix
* Contraindications to radiotherapy
* Male patients
* History of another malignancy diagnosed within the past 5 years
* Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator
* Patients unable to understand or complete the study questionnaires
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q
Timeframe: Baseline, 1 month after surgery, and 12 months after surgery