Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction (SCderm)

After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).

The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Reconstruction; Breast Cancer Female
• Intervention / Treatment: Biological: Transplant acellular dermal matrix(ADM)

Detailed Description

In South Korea, breast reconstruction using implants or autologous abdominal tissue is commonly performed to address the aesthetic and psychological needs of patients who have undergone total mastectomy for breast cancer. In such procedures, acellular dermal matrix (ADM) is used to compensate for soft tissue and skin deficits resulting from tumor resection.

This clinical study is designed to evaluate differences in clinical efficacy, aesthetic outcomes, and safety between ADM processed using supercritical carbon dioxide technology and conventional ADM products in breast reconstruction surgery.

The test group will prospectively enroll 60 patients undergoing breast reconstruction using SC Derm (an investigational ADM processed with supercritical carbon dioxide technology). The control group will retrospectively include 60 patients who underwent breast reconstruction using other ADM products, based on medical records from 2022.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 04401
      • Soon Chun Hyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients who have undergone total mastectomy due to breast cancer from three primary university hospitals.

Description

Inclusion Criteria:

• Female patients aged 20 to 69 scheduled for total mastectomy
• Patients who are willing to undergo immediate breast reconstruction using implants.

Exclusion Criteria:

• Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
• Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
• Patients who have participated in another clinical trial within 120 days prior to screening.
• Any other cases where the investigator deems the patient unsuitable for this clinical study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test Group; Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology).	Biological: Transplant acellular dermal matrix(ADM); The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation.
Control Group; The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022. Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study. For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study.	Biological: Transplant acellular dermal matrix(ADM); The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale	Cosmetic outcomes will be independently assessed by two qualified specialists based on standardized breast photographs taken preoperatively and at 6 months postoperatively. The evaluation will include breast shape, volume, symmetry, nipple-areolar complex, and scar. Each item will be scored using a 5-point Likert scale (1-5), where higher scores indicate better cosmetic outcomes: = Very dissatisfied; = Dissatisfied; = Neutral; = Satisfied; = Very satisfied The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baker's grade of capsular contracture	The occurrence of capsular contracture will be assessed clinically at the same follow-up visits (1 month and 6 months post-surgery). Grade I: Breast is normally soft and appears natural Grade II: Breast is a little firm but appears normal Grade III: Breast is firm and appears abnormal Grade IV: Breast is hard, painful, and appears abnormal	6 months after surgery
Complication Assessment	Evaluate the frequency and incidence rate of most commonly occurred complications of infection, skin necrosis, seroma, hematoma, implants removal.	from the operation day to 6 months after surgery
Subject's Satisfaction Assessment	Patient self-assessment of satisfaction with surgical outcomes will be evaluated at 1 month and 6 months postoperatively. Satisfaction will be assessed using a 4-point categorical scale (1-4), as follows: = Poor (not satisfied); = Fair (neutral); = Good (satisfied); = Excellent (very satisfied) Higher scores indicate greater patient satisfaction.	Beaseline to 6 months

Collaborators and Investigators

• Sponsor: DOF Inc.
• Investigators: Principal Investigator: Woojin Song, Ph.D, Soon Chun Hyang University

Publications and helpful links

Helpful Links

• Polotto S, Bergamini ML, Pedrazzi G, et al. One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting. Gland Surg 2020;9(2):219-228.
• Hagarty SE, et al. Decreased length of postoperative drain use, parental opioids, length of stay and complication rates in patients receiving meshed versus unmeshed ADM. Plast Reconstr Surg 2020; 145(4):889-897.
• Viezel-Mathieu A, Alnaif N, Aljerian A, et al.Acellualr dermal matrix-sparing direct-to-implant prepectoral breast reconstruction: A comparative study including cost analysis. Ann Plast Surg 2020;84(2):139-143.
• Nam SY, Youn D, Kim GH, et al. In vitro characterization of a novel human acellular dermal matrix (BellaCell HD) for breast reconstruction. Bioengineering (Basel) 2020;7(2):39.
• Heath, D.E. A Review of Decellularized Extracellular Matrix Biomaterials for Regenerative Engineering Applications. Regen. Eng. Transl. Med. 2019;5;155-166.
• Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018; 67:270-281
• Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012;15(4):373-380
• Sforza M, Husein R, Atkinson C, Zaccheddu R. Unraveling Factors Influencing Early Seroma Formation in Breast Augmentation Surgery. Aesthet Surg J. 2017 Mar 1;37(3):301-307.
• A retrospective review of breast reconstruction outcomes comparing AlloDerm and DermaCELL. Heather Greig, Janine Roller, William Ziaziaris, Nancy Van Laeken. JPRAS Open, 2019 Jul;22:19-26

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acellular Dermal Matrix(ADM); Breast Reconstruction using implants and ADM
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2023-01-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No