Breast NeoplasmsNCT07345026
Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
A study testing Acellular Dermal Matrix (SureDerm BCS) and Standard Breast-Conserving Surgery in people with Breast Neoplasms and Mastectomy, Segmental, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Mastectomy, Segmental
- What is being tested?
- Acellular Dermal Matrix (SureDerm BCS) and Standard Breast-Conserving Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, Seoul, 06591
Chang Ik Yoon, MD, PhD, +82-2-2258-6109, fayn03@gmail.com
About this study
Official title: 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:
Read more
- Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?
- 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
- Conditions
- Breast Neoplasms, Mastectomy, Segmental
- Being tested
- Acellular Dermal Matrix (SureDerm BCS), Standard Breast-Conserving Surgery
- Keywords
- Breast Cancer, Breast-Conserving Surgery, Acellular Dermal Matrix, Oncoplastic Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal Matrix (SureDerm BCS)Device
Also called Acellular Dermal Matrix
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.
Standard Breast-Conserving SurgeryProcedure or surgery
Also called Lumpectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast-Conserving Surgery With SureDerm | Experimental | Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy. Receives: Device: Acellular Dermal Matrix (SureDerm BCS) |
| Breast-Conserving Surgery Without SureDerm | Active comparator | Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy. Receives: Procedure: Standard Breast-Conserving Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month after surgery, and 12 months after surgery
Secondary outcomes (3)
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.
Measured: 1 month after surgery, and 12 months after surgery
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.
Measured: 1 month and 12 months after surgery
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.
Measured: 1 month and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start8 Jan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with 1:1 randomization (ADM vs no ADM)
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ik Yoon, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345026
- Sponsor's protocol ID
- XC25EIDV0042
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kwon J, Byon JH, Ko BK, Kim JS, Bang M. Clinical progression following acellular dermal matrix use for volume replacement after breast-conserving surgery. BMC Surg. 2025 Mar 5;25(1):91. doi: 10.1186/s12893-025-02821-z.
PubMed 40045324Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07345026
- Acronym / sponsor ID
- XC25EIDV0042
- Conditions
- Breast Neoplasms, Mastectomy, Segmental
- Keywords
- Breast Cancer, Breast-Conserving Surgery, Acellular Dermal Matrix, Oncoplastic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 8 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment with 1:1 randomization (ADM vs no ADM)
| Arm | Type | Receives |
|---|---|---|
| Breast-Conserving Surgery With SureDerm | Experimental | Device: Acellular Dermal Matrix (SureDerm BCS)Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy. |
| Breast-Conserving Surgery Without SureDerm | Active comparator | Procedure: Standard Breast-Conserving SurgeryParticipants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Dermal Matrix (SureDerm BCS)Also: Acellular Dermal MatrixParticipants 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. | Device | Breast-Conserving Surgery With SureDerm |
| Standard Breast-Conserving SurgeryAlso: LumpectomyParticipants 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. | Procedure or surgery | Breast-Conserving Surgery Without SureDerm |
Primary outcome
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.
3 secondary outcomes
Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm
Time frame: 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
Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale
Time frame: 1 month and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 40045324Kwon J, Byon JH, Ko BK, Kim JS, Bang M. Clinical progression following acellular dermal matrix use for volume replacement after breast-conserving surgery. BMC Surg. 2025 Mar 5;25(1):91. doi: 10.1186/s12893-025-02821-z.
- Results publication: PubMed 19644246Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix (SureDerm BCS) and Standard Breast-Conserving Surgery in people with Breast Neoplasms and Mastectomy, Segmental, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Ik Yoon, MD, PhD (+82-2-2258-6109, fayn03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q (time frame: Baseline, 1 month after surgery, and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07345026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.