Observational Study of AlloMend® Acellular Dermal Matrix in Pre-Pectoral Breast Reconstruction

This study is looking at how well AlloMend® Acellular Dermal Matrix allograft works for women having breast reconstruction after a single or double mastectomy. AlloMend® is a special tissue product made from donated human skin that helps support breast implants. Researchers want to understand its effectiveness when used in a type of surgery called pre-pectoral breast reconstruction. You could join if you are a woman aged 18 or older who has had or will have a single or double mastectomy and pre-pectoral breast reconstruction using AlloMend®. This is an observational study, meaning researchers will collect information on patients who have already had this surgery or will have it, rather than assigning treatments. The study aims to gather descriptive information for up to 6 months after surgery. The current recruitment status is unclear.

Study design
This is a single-center, retrospective observational study planning to include 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 months after their surgery.

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NCT06512259

AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Recruiting
Not specifiedAges 18+Observational
AlloSource
~200 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:AlloMend® Acellular Dermal Matrix allograft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Descriptive Data Collection
Measured over Up to 6- months post-operatively
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
1 sites across 1 states
Illinois1

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Eligibility criteria

Inclusion

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

Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
Did not have post-operative evaluations at the clinical site.
  • Descriptive Data CollectionUp to 6- months post-operatively

    The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.