Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 10:53 AM
Study NCT ID:
NCT06553859
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
Sponsor:
DOF Inc.
Organization:
Study Overview
Official Title:
Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCderm
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: