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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | 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.) |
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| Control Group | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention conducts. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of occurrences of pre-determined expected adverse events and complications | The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group. | From the day of operation of breast reconstruction to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey | 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. |
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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.
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The study is scheduled to include 50 prospective and 50 retrospective subjects. The retrospective recruitment period for subjects is from June 1, 2021 to November 9, 2021. Patients who meet the inclusion criteria will be consecutively selected from patients who underwent breast reconstruction with implants. The basis for calculation of retrospective patients was not statistically calculated, but considering that the number of implant breast reconstruction patients at our hospital is 500 per year, when only patients who completed follow-up for more than 1 year were included, approximately 5-10% were enrolled in the study. This was expected and calculated to be possible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsup Um | Contact | +82 02-3010-3600 | jinsupp@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jinsup Um | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| Label | URL |
|---|---|
| Mazari FAK, Wattoo GM, Kazzazi NH, et al. The comparison of strattice and surgimend in acellular dermal matrix-assisted, implant-based immediate breast reconstruction. Plast Reconstr Surg 2018;141(2):283-293 | View source |
| Polotto S, Bergamini ML, Pedrazzi G, et al. One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting. Gland Surg 2020;9(2):219-228 | View source |
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| From the day of operation of breast reconstruction to 12 months |
| Decreased length of postoperative drain use, parental opioids, length of stay and complication rates in patients receiving meshed versus unmeshed acellular dermal matrix in 194 submuscular tissue expander-based breast reconstructions | View source |
| Viezel-Mathieu A, Alnaif N, Aljerian A, et al.Acellualr dermal matrix-sparing direct-to-implant prepectoral breast reconstruction: A comparative study including cost analysis. Ann Plast Surg 2020;84(2):139-143 | View source |
| Nam SY, Youn D, Kim GH, et al. In vitro characterization of a novel human acellular dermal matrix(BellaCell HD) for breast reconstruction. Bioengineering(Basel) 2020;7(2):39. | View source |
| Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018;67:270-281 | View source |