RECRUITING

AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Conditions

Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2023-10-19

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06512259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction * Did not have post-operative evaluations at the clinical site.

Inclusion Criteria

Exclusion Criteria

* 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.

* Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
* Did not have post-operative evaluations at the clinical site.

Contacts and Locations

Study Contact

Elizabeth Esterl, DNP, MS, RN

CONTACT

7207326231

eesterl@allosource.org

Nicole Litton, BS

CONTACT

2815076061

nlitton@allosource.org

Study Locations (Sites)

Alan H. Chen Surgical Associates, PC

Joliet, Illinois, 60435

United States

Collaborators and Investigators

Sponsor: AlloSource

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-19

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-10-19

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy