Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
NCT ID: NCT06553859
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-06-12
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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.)
No 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.
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.
No interventions assigned to this group
Interventions
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No 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
20 Years
80 Years
FEMALE
No
Sponsors
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DOF Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jinsup Um
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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
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
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
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
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.
Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018;67:270-281
Other Identifiers
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2023-01-001
Identifier Type: -
Identifier Source: org_study_id
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