Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555614
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Evaluation of Safety of Acellular Dermal MatrixADM in Breast Reconstruction
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADM
Brief Summary:
The goal of this observational study is to evaluate the safety of Acellular Dermal MatrixADM 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 ReconADM 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
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 ReconADM 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None