The MATRIX-IDE is a prospective clinical trial that was designed by Scot B. Glasberg, MD, FACS. This study was designed to evaluate the safety and efficacy of Acellular Dermal Matrices (ADMs) and Surgical Mesh products in two-stage, prosthetic-based breast reconstruction.
ADMs and surgical meshes include synthetic, human or animal-derived products that are often used for soft tissue support in surgery. These products make a wider variety of surgical techniques in breast reconstruction possible. Unlike other implantable medical devices – ADMs become vascularized and incorporated into the patient's body. Many ADMs and surgical meshes have been approved for other indications, but to date, no ADM or surgical mesh is approved for on-label use in breast reconstruction.
Many researchers are interested in evaluating the safety and efficacy of these medical devices in breast reconstruction. However, there are several known challenges to studying these devices. Below, we list a few of these challenges and how the MATRIX-IDE addresses each challenge.
Challenge 1: ADMs are commonly used off-label for breast reconstruction
ADMs have been used in breast reconstruction for over two decades. This off-label use has become part of the standard of care. The best surgical approach for any patient should be discussed between the surgeon and the patient during the preoperative visits. Often, a surgeon may believe the best approach for reconstruction for a patient would be to use ADM or surgical mesh to offer additional soft tissue support. The gold standard for clinical research is a controlled, randomized trial. However, in this case, a controlled randomized trial is not a practical approach, given the frequency of off-label use of ADMs in breast reconstruction.
Solution 1: The MATRIX-IDE is an observational, standard-of-care study
Breast reconstruction is a personal decision for each patient and should be made with fully informed consent regarding the risks and benefits of the different procedures, techniques, and medical devices to support the surgery. It is practical to allow the patient and surgeon to make a joint decision regarding the best device and technique for breast reconstruction for the individual patient. Therefore, the MATRIX-IDE does not randomize patients to study arms but rather gathers observational data on the surgeries that patients would choose to have regardless of study participation.
Challenge 2: Without randomization, selection bias is a concern
If a clinical trial cannot be randomized – the researchers risk selection bias by the surgeon for participation in each control or study arm.
Solution 2: Each surgeon may only participate in a single study arm
To mitigate the risk of selection bias, The PSF has designed the study such that each surgeon (investigator) involved will only be allowed to enroll patients into a single control or study arm.
Challenge 3: Efficacy is difficult to measure in breast reconstruction
The efficacy of a device used in breast reconstruction is tied to aesthetic outcome, and few validated tools exist to measure aesthetic outcome in breast reconstruction.
Solution 3: The PSF is developing innovative tools to quantify aesthetic outcomes
The PSF is developing novel proprietary data capture tools and methods to measure aesthetic outcomes in breast reconstruction. These will assess aesthetic outcomes in a standardized manner to support establishing the efficacy of devices in breast reconstruction.
Challenge 4: Control patients for this type of study are limited
Given the frequency of off-label use of ADMs or surgical meshes in breast reconstruction, there are a limited number of patients who can participate in the control arms of the study. Women who have prosthetic-based breast reconstruction without ADM or surgical mesh are increasingly rare.
Solution 4: The PSF shares a controlled patient population across multiple devices
This study allows multiple ADM or surgical mesh manufacturers to participate in the study and share control data. The PSF has no limit to the number of devices that can participate and invites any device manufacturer that is interested in joining the IDE to connect with us. Each manufacturer can join the study and compare their device's safety and efficacy against a common control group.
The Plastic Surgery Foundation is interested in partnering with any device manufacturer that wants to include their device in the MATRIX-IDE.
If you are interested in learning more about participating in the MATRIX-IDE, please contact PSF Director of Clinical Research Operations Maria Jones at email@example.com.