AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Recruiting

• Conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

• Registration Number: NCT06512259
• Lead Sponsor: AlloSource

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>Patients must meet the following inclusion criteria to participate in this study:<br><br> - Diagnosed by a physician and required a single or double mastectomy followed by<br> Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular<br> Dermal Matrix allograft;<br><br> - Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;<br><br> - Has completed or will complete the anticipated clinically indicated follow-up visits<br> at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.<br><br>Exclusion Criteria:<br><br>Patients must not meet any of the following criteria to be considered for this clinical<br>trial:<br><br> - Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral<br> breast reconstruction<br><br> - Did not have post-operative evaluations at the clinical site.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive Data Collection

Secondary Outcome Measures

Name	Time	Method
Physical Function and Quality of Life