Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

NCT06555614 | Recruiting

• 1 other identifier: 2023-01-005
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Conditions

Breast Cancer Female; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM

  The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).

  From the day of operation of breast reconstruction to 12weeks

Study Arms (2)

Test Group

A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology.

Other: Acellular Dermal Matrix(ADM)

Control Group

A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents.

Other: Acellular Dermal Matrix(ADM)

Interventions

Acellular Dermal Matrix(ADM) OTHER

A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.

Control Group; Test Group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.

You may qualify if:

• Prospective Subjects (Test Group):
• Female patients aged 19 to 79 years
• Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
• Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits
• Retrospective Medical Record Collection (Control Group):
• Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
• Availability of medical records between March 1, 2021, and March 31, 2024

You may not qualify if:

• Prospective Subjects (Test Group):
• \- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)
• Retrospective Medical Record Collection (Control Group):
• \- Patients with no recorded follow-up visits after application of the acellular dermal matrix

Sponsors & Collaborators

• DOF Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Related Links

• National Health Insurance: Early Treatment Increases Survival Rates for Breast Cancer Patients, with a 6.9% Increase Over the Past 5 Years. Press Release, 2023-05-26.
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• Colwell AS, Taylor EM. Recent Advances in Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2020 Feb;145(2):421e-432e.
• Sigurdson L, Lalonde DH. MOC-PSSM CME article: Breast reconstruction. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-12.
• Gabriel A, Maxwell GP. Discussion: Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):444-446.
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• Vidya R, Cawthorn SJ. Muscle-Sparing ADM-Assisted Breast Reconstruction Technique Using Complete Breast Implant Coverage: A Dual-Institute UK-Based Experience. Breast Care (Basel). 2017 Sep;12(4):251-254.
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• Cattelani L et. al., One-Step Prepectoral Breast Reconstruction With Dermal Matrix-Covered Implant Compared to Submuscular Implantation: Functional and Cost Evaluation. Clin Breast Cancer. Clin Breast Cancer. 2018 Aug;18(4):e703-e711.
• Walter RJ, Matsuda T, Reyes HM, Walter JM, Hanumadass M. Characterization of acellular dermal matrices (ADMs) prepared by two different methods. Burns. 1998 Mar;24(2):104-13.
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• Giang NN, Trinh XT, Han J, Chien PN, Lee J, Noh SR, Shin Y, Nam SY, Heo CY. Effective decellularization of human skin tissue for regenerative medicine by supercritical carbon dioxide technique. J Tissue Eng Regen Med. 2022 Dec;16(12):1196-1207.

Study Officials

• Kiyong Hong, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kiyong Hong, Ph.D

CONTACT

+82 02-2072-0310; kyhong@snu.ac.kr

Hyejin Ryu

CONTACT

+82-10-3514-6968; rtyuok2@outlook.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)