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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Acellular Dermal Matrix (SureDerm BCS)
DeviceParticipants 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.
Standard Breast-Conserving Surgery
Procedure/SurgeryParticipants 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Breast-Conserving Surgery With SureDermExperimental treatment 1 intervention
Group B: Breast-Conserving Surgery Without SureDermActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q
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.
Time frame
Baseline, 1 month after surgery, and 12 months after surgerySecondary outcomes
1
Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm
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.
Time frame
1 month after surgery, and 12 months after surgery2
Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction
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.
Time frame
1 month and 12 months after surgery3
Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale
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.
Time frame
1 month and 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: