Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504173
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Diced Cartilage in Breast Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment which can lead to contour deformity in the craniomedial breast pole This study evaluated the use of diced cartilage DC to counteract substance loss in the microvascular anastomosis area and investigated safety and suitability of the procedure to avoid postoperative deformities
Detailed Description:
This retrospective single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023 Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy DC vs DCR The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging MRI 6 months post-op and photographic documentation 6-month follow-up
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