Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients
NCT ID: NCT07345026
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
116 participants
INTERVENTIONAL
2026-01-08
2028-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
FEMALE
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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Chang-Ik Yoon
Assistant Professor
Locations
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Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Gorbunov SG, Gorelov AV, Kosorotikova AI. [Etiological structure of acute respiratory viral infections in children hospitalized in 1981-1999]. Zh Mikrobiol Epidemiol Immunobiol. 2001 Nov-Dec;(6):25-7. Russian.
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.
Other Identifiers
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XC25EIDV0042
Identifier Type: -
Identifier Source: org_study_id
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