Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-75
SponsorSeoul St. Mary's Hospital
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Acellular Dermal Matrix (SureDerm BCS)
- Standard Breast-Conserving Surgery
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov