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

January 7, 2026 updated by: Chang-Ik Yoon, Seoul St. Mary's Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chang Ik Yoon, MD, PhD
  • Phone Number: +82-2-2258-6109
  • Email: fayn03@gmail.com

Study Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 06591
        • Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast-Conserving Surgery With SureDerm
Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.
Device: Acellular Dermal Matrix (SureDerm BCS)
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
Active Comparator: Breast-Conserving Surgery Without SureDerm
Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.
Procedure: Standard Breast-Conserving Surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month after surgery, and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after surgery, and 12 months after surgery
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.
1 month and 12 months after surgery
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.
1 month and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC25EIDV0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data (IPD) due to privacy concerns and regulatory restrictions. De-identified, aggregate data will be reported in peer-reviewed journals and scientific meetings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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