DermaMatrix Acellular Dermis. Human dermal collagen matrix.
Rehydrates quickly
Does not require refrigerated storage
Bacterially inactivated DermaMatrix Acellular Dermis
DermaMatrix Acellular Dermis is processed by the Epidermis Musculoskeletal Transplant Foundation (MTF) and is available through Synthes CMF.
DermaMatrix tissue is an allograft derived from donated human skin. The epidermis and dermis are removed from the subcutaneous layer of the skin during the recovery procedure. The tissue is then processed using a sodium Dermis chloride solution and detergent to remove the epidermis and all viable dermal cells while maintaining the original dermal collagen matrix. The cells are removed to minimize Subcutaneous layer inflammation or rejection at the surgical site. Normal human skin DermaMatrix Acellular Dermis is then treated in a disinfection solution that combines detergents with acidic and antiseptic reagents to further clean the tissue so that it passes the United States Pharmacopeia Standard 71 (USP <71>) for sterility. Finally, it is freeze-dried, cut to size and packaged in a terminally sterilized double pouch and envelope.
When ready for use, DermaMatrix tissue should be rehydrated in at least 100 ml of sterile, room temperature saline or DermaMatrix 3D Collagen Matrix lactated Ringer’s solution. It will typically rehydrate in three minutes or less to a uniformly soft and pliable consistency. Additional rinsing to remove any residuals is not needed. Transplanted Acellular After DermaMatrix Acellular Dermis is transplanted into the Dermis patient, host cells begin to infiltrate the three-dimensional Fibroblasts collagen matrix. The patient’s blood vessels revascularize the implant and fibroblasts are incorporated into the matrix.
Blood vessels Remodeled skin
white indicates absence of cells Epidermis Collagen
Viable cells Dense collagen matrix
Human tissue, with cells intact DermaMatrix, with cells removed (200X magnification) (200X magnification)
Synthes CMF 1 DermaMatrix Acellular Dermis continued
Features – Rehydrates quickly* – Is aseptically processed and passes USP <71> for sterility. The tissue is bacterially inactivated by the disinfection process, which reduces the level of bacteria, spores, fungi, mold and yeast – Does not require refrigeration—freeze-dried tissue can be stored under normal room temperature conditions – Minimizes the amount of autograft needed – Non-cross-linked – Allows revascularization and cell repopulation in the three-dimensional collagen matrix for normal tissue DermaMatrix tissue is notched so that when positioned as shown remodeling** (with the notch in the upper left corner), the epidermal side of – Minimizes inflammation or rejection at the surgical site, the tissue (basement membrane) is facing up. as a result of the tissue processing which removes viable cells and antigens – Has a three-year shelf life – Has 90% consistency of thickness across the length of the tissue
* Reconstitution time may vary with size and thickness of the tissue, temperature of saline or lactated Ringer’s solution and/or donor’s tissue property. ** Acellular Dermal Matrix. MTF internal report summarizing test results of Acellular Dermal Matrix on biomechanical properties, histological profile, structural analysis, preclinical evaluation and tissue safety.
2 Synthes CMF DermaMatrix Acellular Dermis Clinical Applications
DermaMatrix tissue is for homologous use only. Homologous use as defined by the FDA is: The replacement or supplementation of a recipient’s tissue with a tissue form that performs the same basic function or functions in the recipient as in the donor.
Clinical applications include, but are not limited to, the following: – Parotidectomy – Tympanoplasty Breast reconstruction Oral cavity repair – Facial soft tissue defects postmastectomy – Facial sling – Lower eyelid reconstruction – Nasal reconstruction – Nasal septal perforation – Cleft palate repair – Oral resurfacing – Vestibuloplasty – Radial forearm freeflap repair – Breast reconstruction postmastectomy – Abdominal wall repair Nasal septal perforation Abdominal wall repair
Indications DermaMatrix tissue is processed to remove cells while maintaining the integrity of the matrix with the intent to address the issues of the specific and nonspecific inflammatory responses. It is used for the replacement of damaged or inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.
Contraindications Use of DermaMatrix tissue in patients exhibiting autoimmune connective tissue disease is not recommended. – Specific or nonspecific immune response to some component of the graft
Please refer to the package insert for additional precautions and adverse effects.
Synthes CMF 3 Tissue Properties
Biomechanical properties** Tensile strength of acellular dermis
DermaMatrix tissue has been subjected to biomechanical 100 DermaMatrix tissue (N=29) testing to characterize its physical properties. Testing was 90 Competitor (N=12)
conducted by MTF, in accordance with MTF established 80
procedures and ASTM International standards, for mechanical 70 63.2 strength and ability to hold suture. Test results were compared 60
to the properties of a leading competitive dermal matrix 50 material. 44.2 40
30 DermaMatrix Acellular Dermis demonstrates superior 20 14.6 biomechanical properties in comparison with the leading 10 8.0 competitor’s dermal matrix material. It exhibits an average 0 2 tensile strength, an intrinsic property, of 14.6 N/mm and Tensile strength Peak load 2 can withstand an average maximum load of 63.2 N prior (N/mm ) (N) to yielding. The competitor’s material, when subjected to Tensile modulus of acellular dermis the same testing, exhibited an average tensile strength of 18 8.0 N/mm2 and a maximum load before yield of 44.2 N. DermaMatrix tissue (N=29) 16 Competitor (N=12) The average elastic modulus, or ability of DermaMatrix 14 tissue to resist deformation, is 8.8 MPa, compared to 12
5.8 MPa for the competitor’s matrix. 10 8.8
8 Suture retention testing showed that DermaMatrix tissue 5.8 6 is equivalent to the competitor’s material. 4 These biomechanical properties are significant when consider- 2 ing applications, such as abdominal wall repair, where material 0 Modulus strength and stiffness are required to promote healing and (MPa) prevent additional failures at the wound repair site. DermaMatrix Acellular Dermis demonstrates a higher tensile modulus, or greater resistance to stretching and deformation in laboratory testing.
Suture retention strength of acellular dermis
50 DermaMatrix tissue (N=26) 45 Competitor (N=6)
40
35
30
25
20
15
10
5 2.9 2.9 0 Suture retention (MPa) DermaMatrix Acellular Dermis shows higher biomechanical strength than the ** Acellular Dermal Matrix. MTF internal report summarizing test results of leading competitor’s material. Tensile strength data (top) and suture retention Acellular Dermal Matrix on biomechanical properties, histological profile, strength (bottom) are shown. structural analysis, preclinical evaluation and tissue safety.
4 Synthes CMF DermaMatrix Acellular Dermis Histological profile DermaMatrix Acellular Dermis has been processed to remove cells while main- taining histomorphological integrity. Standard histology and immunohisto- chemical methods have been used to assess the dermal matrix structure and its components. Hematoxylin and eosin staining of normal human skin and DermaMatrix tissue show that the Hematoxylin and eosin staining of normal skin (left) and DermaMatrix Acellular Dermis (right) from the same donor. Note absence of cells and matrix is preserved during processing preservation of matrix structure after processing. and demonstrates an absence of the epidermis and cells in the resulting matrix.
Using immunohistochemical staining methods, Types I and III collagen and elastin were evaluated in DermaMatrix Acellular Dermis. The collagen compo- nents are not affected during processing, demonstrated by consistent staining throughout the matrix. Immunohistochemical staining shows Type I collagen in normal skin (left) and staining in DermaMatrix Acellular Dermis (right). Elastin fibers also remain present after processing, as seen by darkly stained strands throughout the acellular dermal matrix. Elastin, in conjunction with col- lagen, contributes to the strength and structure of the dermal matrix scaffold.
Immunohistochemical staining shows Type III collagen in normal skin (left) and staining in DermaMatrix Acellular Dermis (right).
Immunohistochemical staining shows elastin in normal skin (left) and in DermaMatrix Acellular Dermis (right).
All histology courtesy of Premier Laboratory, LLC.
Synthes CMF 5 Tissue Properties continued
Histological profile continued Alcian blue staining reveals that hyaluronan, a major glycosaminoglycan, is present in the tissue. Glycosaminogly- cans and glycoproteins, such as hyaluronan and vitronectin, are integral components of the extracellular matrix and play an important role in cell-cell and cell-matrix interactions.1,2,3 Hyaluronan is present in all living organisms and provides matrix structure and osmotic balance, and assists with cell migration and differentiation.4,5 Vitronectin, an adhesive glycoprotein, binds to collagen, and promotes Immunohistochemical staining using Alcian Blue/PAS shows the cell attachment, proliferation, and differentiation.6 presence of hyaluronan in normal skin (left) and in acellular dermal matrix (right) as indicated by indigo staining. Immunohistochemical evaluation of the acellular dermal matrix confirms that the major components of the extracellular matrix, including collagen, elastin, and major matrix components responsible for promoting cell attachment and growth, are preserved after processing. Cells are effectively removed, leaving the original dermal matrix architecture intact.
Immunohistochemical staining shows vitronectin in normal skin (left) and in acellular dermal matrix (right) as indicated by brown staining.
1. Potter MJ, Linge C, Cussons P, Dye JF, Sanders R. “An investigation to optimize angiogenesis within potential dermal replacements.” Plast Reconstr Surg. 2006 May;117(6):1876-85. 2. Fernandez-Botran R, Gorantla V, Sun X, Ren X, Perez-Abadia G, Crespo FA, Oliver R, Orhun HI, Quan EE, Maldonado C, Ray M, Barker JH. “Targeting of glycosaminoglycan-cytokine interactions as a novel therapeutic approach in allotransplantation.” Transplantation. 2002 Sep 15; 74(5):623-9. 3. Schleicher I, Parker A, Leavesley D, Crawford R, Upton Z, Xiao Y. “Surface Modification by Complexes of Vitronectin and Growth Factors for Serum-Free Culture of Human Osteoblasts.” Tissue Engineering. 11(11-12):1688 (2005). 4. Cohen M, Joester D, Geiger B, Addadi L. “Spatial and Temporal Sequence of Events in Cell Adhesion: From Molecular Recognition to Focal Adhesion Assembly.” Chembiochem. 2004 Oct 4;5(10):1393-9. 5. Turley, EA, Noble PW, Bourguignon LY. “Signaling properties of hyaluranon receptors.” J Biol Chem. 2002 Feb 15; 277(7):4589-92. 6. Rosso F, Giordano A, Barbarisi M, Barbarisi A. “From cell-ECM interactions to tissue engineering.” J Cell Physiol. 2004 May;199(2):174-80.
6 Synthes CMF DermaMatrix Acellular Dermis Structural analysis Structural analysis of acellular dermis using high power transmission electron microscopy reveals that the collagen and elastin components of the extracellular matrix are preserved after processing. Collagen in normal skin is observed in the cross section while in the acellular dermis, the fibers are observed oriented in the transverse direction. Elastin appears as an amorphic structure in both sections. Higher magnification reveals normal periodicity of collagen fibrils in the specimens. TEM analysis shows amorphic elastin and fibrous collagen structures in normal skin (left) and acellular dermis (right).
Higher magnification shows collagen fibrils in normal skin (left) and acellular dermis (right).
Microscopy courtesy of Structure Probe, Inc.
Synthes CMF 7 Donor Selection and Tissue Safety
Musculoskeletal Transplant Foundation (MTF) Donor selection The Musculoskeletal Transplant Foundation (MTF) is All potential donors must pass through an extensive process. a national consortium of medical schools, academic Screening begins at the site of recovery, with a comprehen- institutions and recovery organizations involved in the sive medical and social history that includes the cause of recovery, processing and distribution of bone and related death. Tissue and blood samples are tested for infectious soft tissue for use in transplant surgery. Its quality and diseases that include hepatitis, HIV and syphilis. MTF’s testing safety standards have been developed by leading physicians, requirements exceed current AATB and FDA guidelines. A transplant surgeons, and specialists in the fields of science team of medical/technical specialists from the infectious and medicine. disease and tissue banking fields evaluates all information, including test results. MTF’s quality and safety standards consistently meet or exceed the requirements of the American Association of Tissue safety Tissue Banks (AATB) and the current regulations published Every lot of DermaMatrix Acellular Dermis is tested for by the federal Food and Drug Administration (FDA). MTF is sterility per USP <71>, indicating that there is no microbial also in compliance with established Good Tissue Practices growth on a lot-to-lot basis for release. and the International Standards Organization. MTF has successfully achieved a 5.7 log (almost a 1 million- MTF is AATB accredited and uses the most complete and fold) reduction in microbial levels with their disinfection technically advanced testing available, including Nucleic Acid process— validating the process to consistently reduce Testing (NAT), for detection of transmittable diseases such bacterial levels in DermaMatrix tissue. The microbial as HIV and hepatitis, to assure the safety of every allograft inactivation included the evaluation of a panel of the they supply. most common microorganisms found in the body or on the skin, which includes both aerobic and anaerobic Since its inception in 1987, MTF has recovered and processed species of bacteria, mold, yeast, and fungi: Candida over 50,000 donors. It has distributed more than 3 million albicans, Staphylococcus aureus, Staphylococcus epidermis, tissues and maintains an unrivaled safety record. MTF has Pseudomonas aeruginosa, Clostridium sporogenes and been processing human dermis for 10 years for clinical use. Streptococcus pyogenes.
In addition to meeting United States Pharmacopeia sterility requirements and demonstrating effective inactivation of bacterial load, biocompatibility testing has been conducted in accordance with ISO 10993. This further establishes the safety of the tissue, and exceeds the minimum requirements for AATB compliance. DermaMatrix Acellular Dermis has been subjected to a panel of eight tests for biocompatibility and has been demonstrated to be noncytotoxic, nonhemolytic, and nonmutagenic, confirming that there are no adverse immunologic responses at the acute, subchronic, and chronic levels.
Information on product properties, donor selection and tissue safety has been prepared by the Musculoskeletal Transplant Foundation.
8 Synthes CMF DermaMatrix Acellular Dermis DermaMatrix Acellular Dermis
Size (cm) Thickness (mm) Thickness (inches) Size (cm) Thickness (mm) Thickness (inches) 019204 2 x 4 0.2–0.4 0.008–0.016 011102 1 x 2 0.8–1.7 0.031–0.067 019407 4 x 7 0.2–0.4 0.008–0.016 011104 1 x 4 0.8–1.7 0.031–0.067 011204 2 x 4 0.8–1.7 0.031–0.067 010102 1 x 2 0.4–0.8 0.016–0.031 011307 3 x 7 0.8–1.7 0.031–0.067 010104 1 x 4 0.4–0.8 0.016–0.031 011312 3 x 12 0.8–1.7 0.031–0.067 010204 2 x 4 0.4–0.8 0.016–0.031 011407 4 x 7 0.8–1.7 0.031–0.067 010307 3 x 7 0.4–0.8 0.016–0.031 011412 4 x 12 0.8–1.7 0.031–0.067 010312 3 x 12 0.4–0.8 0.016–0.031 011416 4 x 16 0.8–1.7 0.031–0.067 010407 4 x 7 0.4–0.8 0.016–0.031 011510 5 x 10 0.8–1.7 0.031–0.067 010412 4 x 12 0.4–0.8 0.016–0.031 011612 6 x 12 0.8–1.7 0.031–0.067 011616 6 x 16 0.8–1.7 0.031–0.067
012412 4 x 12 1.7 and > 0.067 and > 1 cm 012416 4 x 16 1.7 and > 0.067 and > 2 cm 2 cm 012510 5 x 10 1.7 and > 0.067 and > 012612 6 x 12 1.7 and > 0.067 and >
4 cm 012616 6 x 16 1.7 and > 0.067 and >
5 cm
6 cm
10 cm
12 cm 16 cm
7 cm
3 cm
4 cm
12 cm
16 cm
Additional sizes may be available. Please contact Synthes sales consultants for details. To order, call Synthes Customer Service at (800) 522-9069 or fax to (877) 534-1560.
Synthes CMF Available through Processed by Synthes CMF Musculoskeletal Transplant 1302 Wrights Lane East Foundation West Chester, PA 19380 125 May Street Telephone: (610) 719-5000 Edison, NJ 08837 To order call: (800) 522-9069 Telephone: (732) 661-0202 Fax: (877) 534-1560 Fax: (732) 661-2298 www.synthes.com
© 2006 Synthes, Inc. or its affiliates. DermaMatrix and Synthes are trademarks of Synthes, Inc. or its affiliates. MTF is a registered trademark of the Musculoskeletal Transplant Foundation. Printed in U.S.A. 8/08 J7237-D