Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control Group | A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the day of operation of breast reconstruction to 12weeks |
Not provided
Not provided
Inclusion Criteria
Prospective Subjects (Test Group):
Retrospective Medical Record Collection (Control Group):
Exclusion Criteria
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
Not provided
Not provided
Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kiyong Hong, Ph.D | Contact | +82 02-2072-0310 | kyhong@snu.ac.kr | |
| Hyejin Ryu | Contact | +82-10-3514-6968 | rtyuok2@outlook.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kiyong Hong, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
Not provided
| Label | URL |
|---|---|
| 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. | View source |
| 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. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Colwell AS, Taylor EM. Recent Advances in Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2020 Feb;145(2):421e-432e. | View source |
| Sigurdson L, Lalonde DH. MOC-PSSM CME article: Breast reconstruction. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-12. | View source |
| 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. | View source |
| 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. | View source |
| Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005 Sep;55(3):232-9. | View source |
| Gamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg. 2006 Jan;56(1):22-5. | View source |
| Bindingnavele V, Gaon M, Ota KS, Kulber DA, Lee DJ. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. J Plast Reconstr Aesthet Surg. 2007;60(11):1214 | View source |
| Zienowicz RJ, Karacaoglu E. Implant-based breast reconstruction with allograft. Plast Reconstr Surg. 2007 Aug;120(2):373-81. | View source |
| Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006 Jul;57(1):1-5. | View source |
| Breuing KH, Colwell AS. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction. Ann Plast Surg. 2007 Sep;59(3):250-5. | View source |
| Spear SL, Parikh PM, Reisin E, Menon NG. Acellular dermis-assisted breast reconstruction. Aesthetic Plast Surg. 2008 May;32(3):418-25. | View source |
| Preminger BA, McCarthy CM, Hu QY, Mehrara BJ, Disa JJ. The influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched-cohort study. Ann Plast Surg. 2008 May;60(5):510-3. | View source |
| Ho G, Nguyen TJ, Shahabi A, Hwang BH, Chan LS, Wong AK. A systematic review and meta-analysis of complications associated with acellular dermal matrix-assisted breast reconstruction. Ann Plast Surg. 2012 Apr;68(4):346-56. | View source |
| Vidya R, Cawthorn SJ. Muscle-Sparing ADM-Assisted Breast Reconstruction Technique Using Complete Breast Implant Coverage: A Dual-Institute UK-Based Experience. Breast Care (Basel). 2017 Sep;12(4):251-254. | View source |
| Vidya R, Iqbal FM. A Guide to Prepectoral Breast Reconstruction: A New Dimension to Implant-based Breast Reconstruction. Clin Breast Cancer. 2017 Jul;17(4):266-271. | View source |
| Sigalove S, Maxwell GP, Sigalove NM, Storm-Dickerson TL, Pope N, Rice J, Gabriel A. Prepectoral Implant-Based Breast Reconstruction: Rationale, Indications, and Preliminary Results. Plast Reconstr Surg. 2017 Feb;139(2):287-294. | View source |
| Cattelani L et. al., One-Step Prepectoral Breast Reconstruction With Dermal Matrix-Covered Implant Compared to Submuscular Implantation: Functional and Cost Evaluation. Clin Breast Cancer. Clin Breast Cancer. 2018 Aug;18(4):e703-e711. | View source |
| Walter RJ, Matsuda T, Reyes HM, Walter JM, Hanumadass M. Characterization of acellular dermal matrices (ADMs) prepared by two different methods. Burns. 1998 Mar;24(2):104-13. | View source |
| Wainwright DJ. Use of an acellular allograft dermal matrix (AlloDerm) in the management of full-thickness burns. Burns. 1995 Jun;21(4):243-8. | View source |
| Lemer ML, Chaikin DC, Blaivas JG. Tissue strength analysis of autologous and cadaveric allografts for the pubovaginal sling. Neurourol Urodyn. 1999;18(5):497-503. | View source |
| Romo T 3rd, Sclafani AP, Sabini P. Reconstruction of the major saddle nose deformity using composite allo-implants. Facial Plast Surg. 1998;14(2):151-7. | View source |
| Neishabouri A, Soltani Khaboushan A, Daghigh F, Kajbafzadeh AM, Majidi Zolbin M. Decellularization in Tissue Engineering and Regenerative Medicine: Evaluation, Modification, and Application Methods. Front Bioeng Biotechnol. 2022 Apr 25;10:805299. | View source |
| Giang NN, Trinh XT, Han J, Chien PN, Lee J, Noh SR, Shin Y, Nam SY, Heo CY. Effective decellularization of human skin tissue for regenerative medicine by supercritical carbon dioxide technique. J Tissue Eng Regen Med. 2022 Dec;16(12):1196-1207. | View source |