Breast Cancer Female
Conditions
Keywords
Breast Reconstruction using Implants and ADM
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.
Interventions
OTHERNo intervention conducts.
The type and method of breast reconstruction with sillicon implants and ADM implanting is now the standard treatment of breast cancer in korea. no any specific intervention has occurred during the surgery.
Sponsors
DOF Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of occurrences of pre-determined expected adverse events and complications | From the day of operation of breast reconstruction to 12 months | The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey | From the day of operation of breast reconstruction to 12 months | Subjects will complete the BREAST-Q survey before and after breast reconstruction surgery, which includes multiple questions on a scale from 1 to 5, where a higher score represents greater satisfaction. For instance, there is a question from the satisfaction with breasts part In the past week, how satisfied or dissatisfied were you with how you look in the mirror with clothes on? The answer would be selected the scale from 1 (Very Dissatisfied) to 4 (Very Satisfied). The evaluation will be implemented by comparison of average scores for each question between the experimental group and the control group. |
Countries
South Korea
Contacts
Primary ContactJinsup Um
Outcome results
None listed