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NCT Number: NCT07345026

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Mastectomy, Segmental Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 06591, South Korea

Location contact

Chang Ik Yoon, MD, PhD

CONTACT

[email protected]

+82-2-2258-6109

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients unable to understand or complete the study questionnaires

Treatment and study plan

Acellular Dermal Matrix (SureDerm BCS)

Device

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.

Other names: Acellular Dermal Matrix

Standard Breast-Conserving Surgery

Procedure

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.

Other names: Lumpectomy

Primary outcomes

  1. Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q

    Time frame: Baseline, 1 month after surgery, and 12 months after surgery

    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.

Secondary outcomes

  1. Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm

    Time frame: 1 month after surgery, and 12 months after surgery

    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.

  2. Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction

    Time frame: 1 month and 12 months after surgery

    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.

  3. Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale

    Time frame: 1 month and 12 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Ik Yoon, MD, PhD

CONTACT

[email protected]

+82-2-2258-6109

Jin Ah Lee, MD

CONTACT

[email protected]

+82-2-2258-6333

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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