Other Clinical Trial - Histological Analysis of AlloMend® Acellular Dermal

Clinical Trial Summary

The primary objective of this study is to histologically evaluate the incorporation of AlloMend® Acellular Dermal Matrix into surrounding native soft tissue. 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.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05744414
Study type	Observational
Source	AlloSource
Contact
Status	Enrolling by invitation
Phase
Start date	May 17, 2023
Completion date	May 2024

Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Clinical Trial Summary

Clinical Trial Description

Study Design

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