NCT07345026

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

Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Neoplasms
• Mastectomy, Segmental

Interventions

Type	Name	Description
DEVICE	Acellular 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.
PROCEDURE	Standard 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.

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-10-01
• Completion: 2028-04-30
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: South Korea