Clinical trial NCT06555614: Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Official title: Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Breast Reconstruction
Lead sponsor: DOF Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Prospective subjects (Test group) 1) Adult women aged 19 to 79 years. 2) Patients who received SC DERM® Recon, an acellular dermal matrix product, during breast reconstruction surgery with implants following a mastectomy due to breast cancer. 3) Individuals who have voluntarily provided written informed consent after receiving an explanation of the study's purpose and methods, are willing to comply with the study protocol, and are willing to visit the hospital for the evaluation of observational parameters.
2. Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product during breast reconstruction surgery with implants following a mastectomy due to breast cancer at Seoul National University Hospital between March 1, 2021, and March 31, 2024.

Exclusion Criteria:

1. Prospective subjects (Test group) 1) Individuals deemed inappropriate for study participation 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 dermal matrix product but have no recorded follow-up visits after application.

Primary outcomes:
measure: Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
timeFrame: From the day of operation of breast reconstruction to 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kiyong Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: