Skip to content

What is Restrata? Unpacking the Synthetic Wound Matrix

3 min read

Restrata is not a pharmacological medication, but a medical device; this synthetic electrospun fiber matrix mimics the human extracellular matrix to promote the body's natural healing process in various types of wounds. Developed by Acera Surgical, it offers a versatile solution for complex and chronic wounds that may not respond to traditional treatments.

Quick Summary

Restrata is a synthetic, bioresorbable fiber matrix, engineered to provide a scaffold for cellular ingrowth and tissue regeneration in chronic and complex wounds, including diabetic and pressure ulcers. It is a medical device, not a traditional drug, and is made from biocompatible materials that degrade naturally as the wound heals.

Key Points

  • Synthetic Medical Device: Restrata is not a drug, but a synthetic, bioresorbable fiber matrix used for wound and soft tissue management.

  • Extracellular Matrix Mimicry: The device's micro-architecture closely resembles the body's natural extracellular matrix, promoting cellular growth and neovascularization.

  • Broad Indications: It is cleared for managing various wounds, including diabetic ulcers, pressure sores, surgical wounds, and recent approval includes soft tissue reinforcement.

  • Consistent and Safe: As a fully synthetic product, it offers excellent biocompatibility, is free of human or animal components, and has a consistent manufacturing profile.

  • Versatile Application: Available in multiple forms (sheet, meshed, micronized) to suit different wound types and complexities.

  • Resorbable Over Time: The matrix degrades naturally through hydrolysis as new tissue forms, leaving native tissue behind.

  • Storage Convenience: Its shelf-stable nature and room temperature storage requirements eliminate the special handling associated with traditional biologics.

In This Article

What is Restrata? An Overview of the Synthetic Fiber Matrix

Unlike traditional medications that rely on pharmacological agents, restrata is a synthetic, bioresorbable medical device. It is manufactured by Acera Surgical using advanced electrospinning technology to create a fibrous matrix from biocompatible synthetic polymers: polyglactin 910 and polydioxanone. This process results in a porous, sub-cellular-sized fiber structure that closely resembles the human body's native extracellular matrix (ECM). This similarity in architecture is key to its function, allowing it to act as a scaffold that supports cellular infiltration, tissue regeneration, and vascularization. It is available in various formats, including sheets, meshed versions, and a micronized form (MiniMatrix) for application to irregular wound topographies.

How the Restrata Matrix Facilitates Healing

The fundamental principle behind Restrata's effectiveness is its bio-inductive design. Once applied to a wound, the porous matrix provides a supportive structure, or scaffold, that allows the patient's own cells to migrate, attach, and proliferate. This scaffolding encourages the formation of new granulation tissue and blood vessels, which are crucial steps in the wound healing cascade. The body's natural processes then progressively resorb the synthetic material via hydrolysis over several weeks, leaving behind healthy, native tissue.

Key aspects of its mechanism include:

  • Providing a framework for cells: The electrospun fibers offer a structural foundation for fibroblasts and other regenerative cells to build new tissue.
  • Mimicking natural tissue: The nanoscale fiber structure imitates the natural ECM, providing the body with familiar signals to initiate repair.
  • Controlled resorption: The matrix degrades at a rate that is matched to the pace of new tissue growth, providing support for as long as it is needed without leaving a permanent foreign body in the tissue.
  • Activation of granulation tissue: In difficult-to-heal (refractory) wounds, Restrata can actively stimulate the formation of granulation tissue, a critical precursor to wound closure.

Indications and Applications of Restrata

Restrata is intended for managing a range of wound types, including chronic wounds like diabetic foot ulcers and venous leg ulcers, pressure ulcers, and various surgical and traumatic wounds. Recent FDA clearance also allows its use for reinforcing soft tissues during surgery. The device offers advantages over traditional biological grafts due to its synthetic source, which results in virtually zero risk of disease transmission and greater consistency. Additionally, it has a long shelf life and requires only room temperature storage.

Potential Adverse Effects and Precautions

As with any medical device, potential adverse effects such as chronic inflammation, infection, or allergic reaction are possible. Healthcare providers should follow precautions including not using Restrata on third-degree burns, thoroughly debriding the wound before application, and ensuring excessive bleeding, swelling, or infection is controlled. Damaged sterile packaging should result in discarding the product.

Conclusion: A Regenerative Solution for Complex Wounds

Restrata represents a significant advance in wound and soft tissue management, utilizing a biocompatible, synthetic matrix to promote tissue regeneration. Its benefits, such as shelf stability, consistency, and low risk of immune reaction, make it a valuable option for treating difficult-to-heal wounds. Restrata is becoming an important tool for clinicians. To learn more about the science behind electrospun materials, you can visit the National Institutes of Health website at {Link: nih.gov https://www.nih.gov/}.

Frequently Asked Questions

No, Restrata is not a pharmacological medication. It is a medical device, specifically a synthetic, bioresorbable fiber matrix used to assist in the healing of wounds and to reinforce soft tissue.

Restrata is made from fully synthetic, biocompatible polymers called polyglactin 910 and polydioxanone. It contains no human or animal-derived materials.

It provides a porous scaffold that mimics the body's natural extracellular matrix, encouraging the infiltration of cells and the growth of new blood vessels. This process, known as granulation, is crucial for tissue regeneration.

Yes, Restrata is specifically indicated for the management of chronic wounds, including diabetic foot ulcers, especially those that are resistant to other forms of treatment.

The Restrata matrix is completely resorbable. As the healing process progresses, the body naturally degrades the synthetic polymers via hydrolysis, leaving behind native tissue.

No, it does not. Unlike some biological products, Restrata is shelf-stable and requires storage at ambient room temperature, avoiding excessive heat or humidity.

Yes, it can. Restrata is compatible with a variety of other wound care products and therapies, including non-adherent dressings, hydrogels, and negative pressure wound therapy (NPWT).

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.