Breast Cancer FemaleADMNCT06555614
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
An observational study of Breast Cancer Female and Breast Reconstruction, run by DOF Inc. at 1 site in South Korea.
Trial summary
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants… Read more about this study
- Who is it for?
- Ages 19 to 79 years, women only
- Conditions the study is for
- Breast Cancer Female, Breast Reconstruction
- What is being tested?
- Acellular Dermal Matrix(ADM)
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2024to 28 Feb 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.
Who may be able to join
- Prospective Subjects (Test Group):
- Female patients aged 19 to 79 years
- Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
- Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits
- Retrospective Medical Record Collection (Control Group):
- Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
- Availability of medical records between March 1, 2021, and March 31, 2024
Who cannot join
- Prospective Subjects (Test Group):
- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)
- Retrospective Medical Record Collection (Control Group):
- Patients with no recorded follow-up visits after application of the acellular dermal matrix
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Hyejin Ryu, +82 10-3514-6968, rtyuok2@outlook.kr
About this study
Official title: Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.
Read the detailed description
Outline:
The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.
The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.
The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.
After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.
Primary Objectives
- To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.
- Conditions
- Breast Cancer Female, Breast Reconstruction
- Being tested
- Acellular Dermal Matrix(ADM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal Matrix(ADM)Other
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology. Receives: Other: Acellular Dermal Matrix(ADM) | |
| Control Group | A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents. Receives: Other: Acellular Dermal Matrix(ADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).
Measured: From the day of operation of breast reconstruction to 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start13 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- DOF Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiyong Hong, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555614
- Sponsor's protocol ID
- 2023-01-005
- Acronym
- ADM
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 28 Apr 2026
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
- ClinicalTrials.gov ID
- NCT06555614
- Acronym / sponsor ID
- ADM / 2023-01-005
- Conditions
- Breast Cancer Female, Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- DOF Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 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 evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.
Detailed description
Outline:
The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.
The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.
The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.
After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.
Primary Objectives
- To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: Acellular Dermal Matrix(ADM)A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology. |
| Control Group | – | Other: Acellular Dermal Matrix(ADM)A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.
Key inclusion criteria (7 listed)
- Female patients aged 19 to 79 years
- Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
- Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits
- Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
- Availability of medical records between March 1, 2021, and March 31, 2024
Key exclusion criteria (4 listed)
- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)
- Patients with no recorded follow-up visits after application of the acellular dermal matrix
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 |
|---|---|---|
| Acellular Dermal Matrix(ADM)A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group. | Other | Control Group, Test Group |
Primary outcome
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
Time frame: From the day of operation of breast reconstruction to 12weeks
The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- National Health Insurance: Early Treatment Increases Survival Rates for Breast Cancer Patients, with a 6.9% Increase Over the Past 5 Years. Press Release, 2023-05-26.Link provided by the sponsor.
- Disa JJ, McCarthy CM, Mehrara BJ, Pusic AL, Hu QY, Cordeiro PG. Postmastectomy reconstruction: an approach to patient selection. Plast Reconstr Surg. 2009 Jul;124(1):43-52.Link provided by the sponsor.
- Colwell AS, Taylor EM. Recent Advances in Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2020 Feb;145(2):421e-432e.Link provided by the sponsor.
- Sigurdson L, Lalonde DH. MOC-PSSM CME article: Breast reconstruction. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-12.Link provided by the sponsor.
- Gabriel A, Maxwell GP. Discussion: Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):444-446.Link provided by the sponsor.
- Sbitany H, Piper M, Lentz R. Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):432-443.Link 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.
Kiyong Hong, Ph.D principal investigator
Seoul National University Hospital
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 and Breast Reconstruction, 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kiyong Hong, Ph.D (+82 02-2072-0310, kyhong@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM (time frame: From the day of operation of breast reconstruction to 12weeks). 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 28 Apr 2026.