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

NCT06555692 | Active Not Recruiting

• 1 other identifier: 2023-01-002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female; Breast Reconstruction

Keywords

Acellular Dermal Matrix(ADM); Breast Reconstruction using implants and ADM

Outcome Measures

Primary Outcomes (1)

• 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: 1. = Very dissatisfied 2. = Dissatisfied 3. = Neutral 4. = Satisfied 5. = Very satisfied The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes.

  6 months after surgery

Secondary Outcomes (3)

• Subject's Satisfaction Assessment

  Beaseline to 6 months

• Baker's grade of capsular contracture

  6 months after surgery

• Complication Assessment

  from the operation day to 6 months after surgery

Study Arms (2)

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)

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)

Interventions

Transplant acellular dermal matrix(ADM) BIOLOGICAL

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; Test Group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DOF Inc.: lead

Study Sites (1)

Soon Chun Hyang University Hospital

Seoul, Seoul, 04401, South Korea

Location

Related 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 Officials

• Woojin Song, Ph.D

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: January 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)