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

NCT07345026 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-01-15

No results posted yet for this study

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

Conditions

  • Breast Neoplasms
  • Mastectomy, Segmental

Interventions

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.

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.

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2027-10-01
Completion
2028-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07345026 on ClinicalTrials.gov