Dermal Fenestrated Matrix
Matrix HD Dermal Fenestrated Matrix is an acellular human dermis that is provided with on-the-shelf storage and has a five-year shelf life. Tutoplast® processed allografts have been used as a wound covering in diabetic ulcers, Charcot foot ulcers, venous ulcers, trauma wounds, pressure sores/ulcers, partial and full thickness wound and surgical wounds.
IMPORTANT: Read the entire instructions for use (IFU), provided with the graft, before using the following quick reference guide.
1. Wound Preparation
Prepare the wound bed per standard protocol. Remember proper debridement is crucial in wound healing. All dead or devitalized tissue should be removed from the wound prior to grafting.
2. GRAFT PREPARATION
Matrix HD Dermal Fenestrated Matrix needs to be rehydrated prior to use by soaking in sterile, room temperature saline solution for at least 30 seconds. Use promptly after rehydration (refer to IFU provided with the graft).
NOTE: The graft is sterile as packaged, but antibiotics agents prescribed by the surgeon may be added to the soaking solution as a precaution against incidental infection. The prescribing surgeon is responsible for selecting an appropriate antibiotic agent at a suitable concentration. Other rehydration methods such as blood and platelet-rich plasma (PRP) have also been used.
3. SIZE & TRIM GRAFT
The graft should be sized according to the tissue defect. An excess border is recommended for adequate fixation of viable tissue.
4. GRAFT ORIENTATION
Some physicians may prefer to apply the graft to the wound bed with the rough side down (rough side making the contact with the wound bed). The rough side of the graft can be determined by dropping a small amount of blood on both sides. (The side that absorbs the blood is considered the “rough” or “down” side.)
5. GRAFT FIXATION
Use the appropriate suture and needle for the surgical procedure. If absorb-able sutures are used, it is recommended to select the longest lasting materials available. Matrix HD Dermal Fenestrated Matrix must be securely placed to prevent displacement and to aid in incorporation to the wound bed.
6. WOUND DRESSING
To maintain a clean and moist wound environment, application of a non-adherent dressing directly over the graft is recommended. Sterile gauze may be applied to maintain “dressing to wound” contact and help keep the graft fixation secure.
Sterile, Room Temperature Human Dermis Graft
Matrix HD Dermal Fenestrated Matrix is a sterilized acellular human dermis graft, processed using the Tutoplast® Tissue Sterilization Process. This specialized method preserves the tissue’s three-dimensional, multidirectional fiber structure and mechanical integrity. Designed to support the body’s natural regenerative processes, Matrix HD Dermal Fenestrated Matrix serves as a biologically compatible scaffold for tissue repair and reconstruction.
Matrix HD Fenestrated Dermal Matrix at a Glance
STERILE
Terminally sterilized to a Sterility Assurance Level (SAL) 10-6 Via the
Tutoplast® Process
BIOCOMPATIBLE
- Maintains preserved vascular channels for optimal integration
- Retains essential components of the native matrix
- Demonstrates revascularization as early as 7 days in an animal model¹
CONVENIENT
- Five year shelf life: The Tutoplast® Process utilizes solvent dehydration, enabling a five-year shelf life without the need for freezing or refrigeration. This proprietary method ensures Matrix HD Dermal Fenestrated Matrix can be conveniently stored at temperatures between 1°C and 37°C, allowing for easy access and use.
- Simple single step rehydration: Matrix HD Dermal Fenestrated Matrix rehydrates in a single step using room temperature sterile saline, requiring minimal time and effort. Its rapid rehydration process helps reduce time and associated costs.
ORDERING
INFORMATIONN – Q4345
- Code Description
- MHD-11 Matrix HD Dermal Fenestrated Matrix 1cm x 1cm
- MHD-22 Matrix HD Dermal Fenestrated Matrix 2cm x 2cm
- MHD-24 Matrix HD Dermal Fenestrated Matrix 2cm x 4cm
- MHD-44 Matrix HD Dermal Fenestrated Matrix 4cm x 4cm
- MHD-46 Matrix HD Dermal Fenestrated Matrix 4cm x 6cm
- MHD-48 Matrix HD Dermal Fenestrated Matrix 4cm x 8cm
- MHD-510 Matrix HD Dermal Fenestrated Matrix 5cm x 10cm
- MHD-1020 Matrix HD Dermal Fenestrated Matrix 10cm x 10cm
- MHD-2020 Matrix HD Dermal Fenestrated Matrix 20cm x 20cm
The Tutoplast Process is a validated chemical sterilization methodology specifically developed to sterilize and preserve tissue for implantation.
TUTOPLAST PROCESS
Overall the structure, biomechanics and remodeling characteristics of the implant are maintained.
THOROUGHLY PENETRATES TISSUE
Osmotic treatments disrupt cell membranes to allow for full penetration of the graft.
VALIDATED VIRAL INACTIVATION
- Ability to inactivate or remove HIV, hepatitis, fungi, and spores
- Validated by individual tissue type based on most difficult case testing using most difficult to kill organisms
How does the Tutoplast® Process work?
Osmotic, oxidative and alkaline (if indicated) treatments break down cell walls, inactivate pathogens, and remove bacteria. Solvent dehydration allows for room-temperature storage of tissue without damaging the native tissue structure. Low-dose gamma irradiation ensures a sterility level (SAL) of 10-6 of the final packaged graft.
Alkaline Treatment
which interfere with healing.
Alkaline Treatment
which interfere with healing.
Osmotic Treatment
Disrupts cell membranes to allow
easier removal of cellular
components.
Oxidative Treatment
bacteria.
Solvent Treatment
Removes water from tissue, preserves the natural
tissue matrix and allows for room-temperature
storage without damaging the native structure.
Irradiation
sterile graft, while preserving structural integrity.
Pre-Processed vs. Tutoplast® Processed Human Dermis
Note presence of intact epidermis.
Tutoplast® Processed Human Dermis
Note epidermis has been removed and underlying matrix has been preserved.
Pre-processed Human Dermis
Note the presence of cellular debris throughout (purple cell nuclei).
Tutoplast® Processed Human Dermis
Note the absence of cellular debris and the intact tissue matrix.
Wound Care Cases
DIABETIC FOOT ULCER
Patient presented with a diabetic ulcer with exposed tendon and bone on the dorsal aspect of the foot. The surgeon used multiple grafts to cover the entire surface of the wound. At three weeks the wound showed a decrease in wound depth and significant granulation tissue present.
INITIAL
PRESENTATION
GRAFT
APPLICATION
3
WEEKS
INSECT BITE
Patient presented with an infected insect bite with exposed tendon and bone on the dorsal aspect of the foot. The wound required two graft applications. At 10 weeks the wound showed 70 percent decrease in size and 80 percent granulation tissue coverage.
INITIAL
DEBRIDEMENT
Application
10
WEEKS
BIOCOMPATIBILITY
IN-VIVO ANIMAL MODEL STUDY
The graft functioned successfully as a scaffold and is fully incorporated and remodeled by the host tissue
DAY 1
Beginning of cellular infiltration of the graft by host tissue.
DAY 7
Vascularization evident, invasion of fibroblasts and other cells found in normal healing cascade of the graft by host tissue.
WEEK 8
Difficult to distinguish implant from host tissue; graft is well incorporated.
WEEK 16
*Performance data from animal studies may not be representative of performance in humans.
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Royal is a pioneering leader in orthobiologic and wound care research and development. Royal’s commitment lies in delivering top-tier, innovative biologic solutions that enhance the healing process and improve patients' quality of life. Royal places patient well-being at the center of its mission, offering exceptional solutions to address a variety of complex needs.
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