NCT07345026

Brief 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:

  • 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

September 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 8, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

September 8, 2025

Last Update Submit

January 7, 2026

Conditions

Breast NeoplasmsMastectomy, Segmental

Keywords

Breast CancerBreast-Conserving SurgeryAcellular Dermal MatrixOncoplastic Surgery

Outcome Measures

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.

    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

    1 month after surgery, and 12 months after surgery

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

    1 month and 12 months after surgery

  • Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale

    1 month and 12 months after surgery

Study Arms (2)

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.

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.

Procedure: Standard Breast-Conserving Surgery

Interventions

Standard Breast-Conserving SurgeryPROCEDURE

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.

Also known as: Lumpectomy
Breast-Conserving Surgery Without SureDerm
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.

Also known as: Acellular Dermal Matrix
Breast-Conserving Surgery With SureDerm

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, Seoul, 06591, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 40045324RESULT

  • Pusic 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.

    PMID: 19644246RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Central Study Contacts

Chang Ik Yoon, MD, PhD

CONTACT

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

Jin Ah Lee, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment with 1:1 randomization (ADM vs no ADM)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 8, 2025

First Posted

January 15, 2026

Study Start

January 8, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

KR(1)