Clinical trial NCT05744414: Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
Official title: Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Implant; Complications, Infection or Inflammation
Lead sponsor: AlloSource
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation

Brief summary: This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.

AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.

Detailed description: The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.

This study will be performed at one (1) clinical center in the United States.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age;
* AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
* Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
* Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.

Exclusion Criteria:

* Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
* Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.

Primary outcomes:
measure: AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application
timeFrame: At expander/implant exchange surgery; typically 1-3 months post expander placement
Secondary outcomes:
measure: Infection rates
timeFrame: Up to 6 months post expander/implant exchange
measure: Seroma rates
timeFrame: Up to 6 months post expander/implant exchange
measure: Hematoma rates
timeFrame: Up to 6 months post expander/implant exchange
measure: Drain outputs and timing of drain removal
timeFrame: Up to 6 months post expander/implant exchange
measure: Revision surgeries
timeFrame: Up to 6 months post expander/implant exchange
Other outcomes:
Locations:
city: Reno
country: United States
facility: Janiga MDs Plastic Surgery and Cosmetic Center
state: Nevada
Study officials:
References: