Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-24 @ 5:19 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of occurrences of pre-determined expected adverse events and complications', 'timeFrame': 'From the day of operation of breast reconstruction to 12 months', 'description': 'The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group.'}], 'secondaryOutcomes': [{'measure': "Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey", 'timeFrame': 'From the day of operation of breast reconstruction to 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Reconstruction using Implants and ADM'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/29369979/', 'label': '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'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7225454/', 'label': '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'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32221196/', 'label': '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'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31335468/', 'label': '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'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32353944/', 'label': '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.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29223704/', 'label': 'Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018;67:270-281'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nPatients who fall into the following categories cannot participate in this clinical study because they meet the exclusion criteria:\n\n1. Patients who have received an organ transplant and are taking any immunosuppressants.\n2. Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.\n3. Individuals who are unable to complete the survey conducted in this clinical study.\n4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.\n5. Patients for whom the investigator determines participation in the study is not appropriate.\n\nAmong 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.\n\nBefore any screening or enrollment, all subjects must confirm their willingness to participate by signing the informed consent form.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy\n\nExclusion Criteria:\n\nPatients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.\n\n1. Patients who have received an organ transplant and are taking any immunosuppressant.\n2. Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.\n3. People who are unable to complete the survey conducted in this clinical study.\n4. Patients who participated in other clinical trials within the previous 120 days at the time of screening.\n5. If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.'}, 'identificationModule': {'nctId': 'NCT06553859', 'acronym': 'SCderm', 'briefTitle': 'Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'DOF Inc.'}, 'officialTitle': 'Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction', 'orgStudyIdInfo': {'id': '2023-01-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.)', 'interventionNames': ['Other: No intervention conducts.']}, {'label': '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.'}], 'interventions': [{'name': 'No intervention conducts.', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Test Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seonghee Kim', 'role': 'CONTACT', 'email': 'pcjazz75@naver.com', 'phone': '+82 02 3010-3600'}, {'name': 'Elisabeth Kim', 'role': 'CONTACT', 'email': 'webmaster@amc.seoul.kr', 'phone': '+82 02 3010-7153'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jinsup Um', 'role': 'CONTACT', 'email': 'jinsupp@amc.seoul.kr', 'phone': '+82 02-3010-3600'}], 'overallOfficials': [{'name': 'Jinsup Um', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DOF Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}