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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07345026
Lead Sponsor Seoul St. Mary's Hospital
Conditions
(from sponsor)		 Breast Neoplasms, Mastectomy, Segmental
Related terms Breast Neoplasms
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov