Clinical trial NCT06512259: AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
Lead sponsor: AlloSource
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 200
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 a Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all of the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.

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 Breast Reconstruction surgery following a single or double mastectomy.

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 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.

Eligibility criteria: Inclusion Criteria:

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 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: Descriptive Data Collection
timeFrame: Up to 6- months post-operatively
Secondary outcomes:
measure: Physical Function and Quality of Life
timeFrame: Up to 6- months post-operatively
Other outcomes:
measure: Qualitative Data
timeFrame: Up to 6- months post-operatively
Locations:
city: Joliet
country: United States
facility: Alan H. Chen Surgical Associates, PC
state: Illinois
Study officials:
References: