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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month after surgery, and 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ik Yoon, MD, PhD | Contact | +82-2-2258-6109 | fayn03@gmail.com | |
| Jin Ah Lee, MD | Contact | +82-2-2258-6333 | jinah8908@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea | Seoul | Seoul | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40045324 | Result | 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. | |
| 19644246 | Result | 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. |
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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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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Parallel assignment with 1:1 randomization (ADM vs no ADM)
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| Standard Breast-Conserving Surgery | Procedure | 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. |
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| 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. | 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. | 1 month and 12 months after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |