Clinical trial NCT06853964: Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
Official title: A 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 12-Months Post-Operatively
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-Pectoral Breast Reconstruction Following Mastectomy
Keywords: AlloMend
Acellular Dermal Matrix
Pre-pectoral Breast Reconstruction
Allografts
Lead sponsor: AlloSource
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who require a single or double mastectomy and have undergone Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.

Brief summary: This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

Detailed description: AlloMend® Acellular Dermal Matrix AlloMend® 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 made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process.

AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.

This retrospective study will be performed at one center in the United States.

Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.

Eligibility criteria: Inclusion Criteria:

Patients must meet the following inclusion criteria to participate in this study:

* Female ≥ 18 years old.
* Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
* Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.

Exclusion Criteria:

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.

Primary outcomes:
measure: Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
timeFrame: Up to 12-month post-operatively
Secondary outcomes:
measure: Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes
timeFrame: Up to 12-month post-operatively
measure: Retrospective Assessment of Patient-Reported Health Status and Quality of Life
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Reno
country: United States
facility: Janiga MDs Plastic Surgery and Cosmetic Center
state: Nevada
Study officials:
References: