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

Last updated: August 14, 2024
Sponsor: DOF Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Treatment

Acellular Dermal Matrix(ADM)

Clinical Study ID

NCT06555614
2023-01-005
  • Ages 19-79
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Prospective subjects (Test group) 1) Adult women aged 19 to 79 years. 2) Patientswho received SC DERM® Recon, an acellular dermal matrix product, during breastreconstruction surgery with implants following a mastectomy due to breast cancer. 3)Individuals who have voluntarily provided written informed consent after receivingan explanation of the study's purpose and methods, are willing to comply with thestudy protocol, and are willing to visit the hospital for the evaluation ofobservational parameters.

  2. Retrospective Medical Record Collection 1) Patients who received an acellular dermalmatrix product during breast reconstruction surgery with implants following amastectomy due to breast cancer at Seoul National University Hospital between March 1, 2021, and March 31, 2024.

Exclusion

Exclusion Criteria:

  1. Prospective subjects (Test group) 1) Individuals deemed inappropriate for studyparticipation by the principal investigator or other investigator's judgement. (e.g., those unable to undergo the required tests for this study).

  2. Retrospective Medical Record Collection 1) Patients who received an acellular dermalmatrix product but have no recorded follow-up visits after application.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Acellular Dermal Matrix(ADM)
Phase:
Study Start date:
June 13, 2024
Estimated Completion Date:
February 28, 2027

Study Description

Outline:

The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.

The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.

The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.

After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.

Primary Objectives

I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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