Breast Neoplasms, Mastectomy, Segmental
Conditions
Keywords
Breast Cancer, Breast-Conserving Surgery, Acellular Dermal Matrix, Oncoplastic Surgery
Brief 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
Interventions
DEVICEAcellular Dermal Matrix (SureDerm BCS)
Participants in this arm will undergo breast-conserving surgery with placement of an acellular dermal matrix (SureDerm BCS). The device is implanted during surgery to provide soft tissue support and improve cosmetic outcomes. All participants will also receive standard postoperative radiotherapy.
PROCEDUREStandard Breast-Conserving Surgery
Participants in this arm will undergo standard breast-conserving surgery without the use of acellular dermal matrix. This procedure involves removal of the breast tumor with preservation of most of the breast tissue. All participants will also receive standard postoperative radiotherapy.
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment with 1:1 randomization (ADM vs no ADM)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q | Baseline, 1 month after surgery, and 12 months after surgery | Patient-reported cosmetic satisfaction will be assessed using the validated Breast-Q (Breast-Conserving Therapy Module) questionnaire at baseline (before surgery), 1 month after surgery, and 12 months after surgery. Scores will be reported as transformed scale scores ranging from 0 to 100, with higher scores indicating greater satisfaction. The change in scores over time will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm | 1 month after surgery, and 12 months after surgery | Complications related to breast-conserving surgery with or without SureDerm will be recorded, including wound infection, seroma, hematoma, delayed wound healing, fat necrosis, and skin necrosis. The incidence and severity of these postoperative surgical complications will be documented. |
| Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction | 1 month and 12 months after surgery | Adverse events and local tissue reactions related to the use of acellular dermal matrix (SureDerm) will be assessed after surgery, including any clinically relevant local complications. |
| Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale | 1 month and 12 months after surgery | Cosmetic outcomes will be assessed by physicians during follow-up visits using the Harvard 4-point cosmetic scale (excellent, good, fair, poor), based on overall breast appearance, symmetry, and shape after surgery. |
Countries
South Korea
Contacts
Primary ContactChang Ik Yoon, MD, PhD
Backup ContactJin Ah Lee, MD
Outcome results
None listed