Breast Cancer FemaleSCdermNCT06553859
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
An observational study of Breast Cancer Female, run by DOF Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2023to Jun 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 1. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
Who cannot join
- Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.
- Patients who have received an organ transplant and are taking any immunosuppressant.
- Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
- People who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Seonghee Kim, +82 02 3010-3600, pcjazz75@naver.com
Elisabeth Kim, +82 02 3010-7153, webmaster@amc.seoul.kr
About this study
Official title: Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
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.
Read the 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:
- Patients who have received an organ transplant and are taking any immunosuppressants.
- Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.
- Individuals who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- 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
- Breast Cancer Female
- Being tested
- No intervention conducts.
- Keywords
- Breast Reconstruction using Implants and ADM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Other: No intervention conducts. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of operation of breast reconstruction to 12 months
Secondary outcomes (1)
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.
Measured: From the day of operation of breast reconstruction to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start12 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- DOF Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinsup Um, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553859
- Sponsor's protocol ID
- 2023-01-001
- Acronym
- SCderm
- Status last verified
- Apr 2024
- First submitted
- 8 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06553859
- Acronym / sponsor ID
- SCderm / 2023-01-001
- Conditions
- Breast Cancer Female
- Keywords
- Breast Reconstruction using Implants and ADM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DOF Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients who have received an organ transplant and are taking any immunosuppressants.
- Patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse.
- Individuals who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: No intervention conducts.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.) |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 1. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
Key exclusion criteria (6 listed)
- Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.
- Patients who have received an organ transplant and are taking any immunosuppressant.
- Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
- People who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Test Group |
Primary outcome
The number of occurrences of pre-determined expected adverse events and complications
Time frame: 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.
1 secondary outcome
Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey
Time frame: From the day of operation of breast reconstruction to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- 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):283-293Link provided by the sponsor.
- 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):219-228Link provided by the sponsor.
- 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 reconstructionsLink provided by the sponsor.
- 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):139-143Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018;67:270-281Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsup Um principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by DOF Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsup Um (+82 02-3010-3600, jinsupp@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of occurrences of pre-determined expected adverse events and complications (time frame: From the day of operation of breast reconstruction to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.