Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874402
Status:
WITHDRAWN
Last Update Posted:
2023-06-18
First Post:
2021-04-30
Brief Title:
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction
Detailed Description:
This is a single center single-blinded randomized clinical trial involving adult women undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction The aim is to generate high quality evidence before establishing the prepectoral technique as routine care A favorable safety and patient satisfaction profile will bring high quality evidence supporting the adoption of a technique that has shown similar complication rates while eliminating animation deformity and its associated pain and discomfort in retrospective and non-randomized studies
The mastectomy flap perfusion will be assessed clinically and using SPY fluorescence imaging Immediately following mastectomy participants will be randomized to one of two treatment arms
Group A will be composed of participants who will undergo prepectoral reconstruction with Acellular Dermal Matrix ADM by means of the anterior tenting technique In this technique two sheets of contour fenestrated ADM sutured together are trimmed in accordance with the measurement of the expanderimplant and fixed to the pectoralis major muscle covering the entire anterior surface of the device
Group B current standard of care SOC will be composed of participants who will undergo partial subpectoral reconstruction with ADM by means of the sling technique In this technique the leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned The lower medial origin muscle fibers are released for anatomical expander seating An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold over the expander and laterally to close the expander pocket
The mastectomy flap perfusion will be assessed clinically and using SPY fluorescence imaging Immediately following mastectomy participants will be randomized to one of two treatment arms
Group A will be composed of participants who will undergo prepectoral reconstruction with Acellular Dermal Matrix ADM by means of the anterior tenting technique In this technique two sheets of contour fenestrated ADM sutured together are trimmed in accordance with the measurement of the expanderimplant and fixed to the pectoralis major muscle covering the entire anterior surface of the device
Group B current standard of care SOC will be composed of participants who will undergo partial subpectoral reconstruction with ADM by means of the sling technique In this technique the leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned The lower medial origin muscle fibers are released for anatomical expander seating An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold over the expander and laterally to close the expander pocket
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None