Status:
RECRUITING
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
Lead Sponsor:
AlloSource
Conditions:
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
Eligibility:
FEMALE
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Patients must meet the following inclusion criteria to participate in this study:
- Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft;
- Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;
- Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.
Exclusion
- Patients must not meet any of the following criteria to be considered for this clinical trial:
- Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
- Did not have post-operative evaluations at the clinical site.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06512259
Start Date
October 19 2023
End Date
December 31 2026
Last Update
November 21 2025
Active Locations (1)
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1
Alan H. Chen Surgical Associates, PC
Joliet, Illinois, United States, 60435