Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512259
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Retrospective Study To Evaluate The Safety And Effectiveness Of AlloMend Acellular Dermal Matrix Used In Post Mastectomy Pre-Pectoral Breast Reconstruction And Followed For Up To 6-Months Post-Operatively
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:
None
Brief Summary:
This is a single-center retrospective study which will be used to describe and evaluate the effectiveness of AlloMend Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy
Detailed Description:
AlloMend Acellular Dermal Matrix is a sterile ready to use human-derived acellular dermal matrix ADM allograft that can be used in a number of reconstructive and other surgical procedures It is made from donated human full-thickness skin After the epidermal and hypodermal layers are removed the tissue is treated by a proprietary cleansing process
AlloMend is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older AlloMend may be used in either one-stage direct-to-implant or two-stage expander-to-implant procedures
AlloMend is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older AlloMend may be used in either one-stage direct-to-implant or two-stage expander-to-implant procedures
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