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Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients | Clinical Trials | Clareo Health

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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

NCT07345026•Seoul St. Mary's Hospital

View on ClinicalTrials.gov

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

Eligibility

Age

20 - 75 years

Sex

FEMALE

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
+1 more criteria

Locations (1)

Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, Seoul, South Korea

Key Dates

Start Date

January 8, 2026

Primary Completion Date

October 1, 2027

Completion Date

April 30, 2028

Last Updated

January 15, 2026

Enrollment

116

ESTIMATED participants

Conditions

Breast NeoplasmsMastectomy, Segmental

Interventions

Acellular Dermal Matrix (SureDerm BCS)

DEVICE

Standard Breast-Conserving Surgery

PROCEDURE

Contacts

Chang Ik Yoon, MD, PhD

CONTACT

+82-2-2258-6109 fayn03@gmail.com

Jin Ah Lee, MD

CONTACT

+82-2-2258-6333 jinah8908@gmail.com

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

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CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE3

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NCT06312176

Breast Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B