A prospective study evaluating the effects of acellular dermal matrix (SureDerm BCS) on cosmetic satisfaction and complication rates in patients undergoing breast-conserving surgery for breast cancer

Clinical Efficacy of acellular dermal matrix (Product name : Surederm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010994

Enrollment

116

Registered

2025-09-09

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Acellular Dermal Matrix (SureDerm BCS)) : This study is a prospective, randomized trial comparing the use of an acellular dermal matrix (ADM, SureDerm™ BCS) versus no ADM in patients undergoing

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and scheduled to undergo breast-conserving surgery. 2) Patients who have agreed to the use of an acellular dermal matrix. 3) Patients with primary breast cancer. 4) Patients who have received neoadjuvant chemotherapy may be included. 5) Patients scheduled to receive standard postoperative treatment, including adjuvant radiotherapy. 6) Patients who have voluntarily decided to participate in this study and have signed the written informed consent form.

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded from this clinical trial: 1) Patients with distant metastasis. 2) Patients with infectious diseases, autoimmune diseases (including specific rheumatic diseases), or coagulation disorders. 3) Patients with adverse reactions to all first-line antibiotics. 4) Patients suspected of having inflammatory infection in the breast area prior to surgery. 5) Patients who are pregnant at the time of enrollment. 6) Patients with clear contraindications to the use of human-derived acellular dermal matrix (ADM). 7) Patients with contraindications to radiotherapy. 8) Male patients. 9) Patients with a history of cancer diagnosis within the past 5 years. 10) Patients deemed by the principal investigator to have difficulty in collecting necessary information. 11) Patients who have difficulty understanding or completing the study questionnaire.

Design outcomes

Primary

Measure	Time frame
Patient-reported aesthetic satisfaction score measured using the BREAST-Q questionnaire at postoperative follow-up visits	—

Secondary

Measure	Time frame
Physician-assessed aesthetic score based on photographic evaluation, and incidence of surgical site complications (wound infection, hematoma, seroma, fat necrosis, graft exposure, etc.)	—

Countries

Korea, Republic of

Contacts

Public ContactChang Ik Yoon

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

fayn03@catholic.ac.kr+82-2-2258-6109

Outcome results