Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients

Seoul St. Mary's Hospital

Status: Not yet enrolling

Conditions: Breast Neoplasms; Mastectomy, Segmental

Treatments: Device: Acellular Dermal Matrix (SureDerm BCS); Procedure: Standard Breast-Conserving Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07345026

XC25EIDV0042

Details and patient eligibility

About

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

Enrollment: 116 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Breast-Conserving Surgery With SureDerm

Experimental group

Description:

Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.

Treatment:

Device: Acellular Dermal Matrix (SureDerm BCS)

Breast-Conserving Surgery Without SureDerm

Active Comparator group

Description:

Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.

Treatment:

Procedure: Standard Breast-Conserving Surgery