Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction (SCderm)

DOF Inc.

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Other: No intervention conducts.

Study type: Observational

Funder types: Industry

Identifiers

NCT06553859

2023-01-001

Details and patient eligibility

About

The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.

Full description

The total number of study subjects is 100, with 50 people recruited prospectively into the test group and 50 people retrospectively into the control group.

The test group will consist of 50 patients aged 20 to 80 who have undergone total mastectomy for breast cancer and are scheduled to undergo immediate breast reconstruction using implants. These subjects will receive SC Derm (ADM processed by DOF Inc.) during the implant-based breast reconstruction surgery.

The control group will consist of 50 patients who will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between June 1, 2021, and November 9, 2021.

Patients who fall into the following categories cannot participate in this clinical study because they meet the exclusion criteria:

1. Patients who have received an organ transplant and are taking any immunosuppressants.
2. Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.
3. Individuals who are unable to complete the survey conducted in this clinical study.
4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.
5. Patients for whom the investigator determines participation in the study is not appropriate.

Among breast cancer patients who decide to undergo implant-based breast reconstruction after total mastectomy at our hospital, the investigator will fully explain the study to these patients during outpatient visits and recruit those who voluntarily express their willingness to participate.

Before any screening or enrollment, all subjects must confirm their willingness to participate by signing the informed consent form.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy

Exclusion criteria

Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.

1. Patients who have received an organ transplant and are taking any immunosuppressant.
2. Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
3. People who are unable to complete the survey conducted in this clinical study.
4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.
5. If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.

Trial design

100 participants in 2 patient groups

Test Group

Description:

Fifty subjects are to be enrolled prospectively. Breast cancer patients who are willing to undergo breast reconstruction surgery based on inserting breast implants with ADM will be selected as the test group, with "SC Derm"(Acellular Dermal Matrix processed by CO2 supercritical fluid technology.)

Treatment:

Other: No intervention conducts.

Control Group

Description:

Fifty subjects are to be enrolled retrospectively from the medical records of breast cancer patients who have undergone breast reconstruction surgery based on inserting breast implants with ADM made by other companies. All breast reconstruction surgeries have operated from 1, June 2021 to 9, November 2021 at Asan medical center at Seoul, South Korea.