Sourced exclusively from the ilio-tibial band of human donors, each Tutoplast® Fascia Lata allograft is meticulously configured to ensure superior load-bearing performance.
The power of this tissue process technology is its ability to (1) render human tissue void of cell debris, antigens and potential viruses, and (2) maintain the structural integrity inherent in the pre-processed collagen.
The Tutoplast® Process is a scientific and technology based method of virally inactivating, preserving and sterilizing human tissue. The Tutoplast® benefits are vast:
- Immunologically safe.
- Biologically and mechanically stable and strong.
- Five year shelf life stored at room temperature.
- Uniform and consistent in tissue quality.
- Multiple configurations available.
During the last 30 years, over 1 million Tutoplast™ Allografts have been surgically implanted without a single documented case of disease transmission.
Tutoplast® is a registered trademark of Tutogen Medical, USA.
- Uni-directional collagen matrix supports long-term load-bearing requirements.
- Five (5) year shelf life; activates in simple saline within minutes.
- Superior tissue quality and consistency.
- Configured in seven (7) lengths: 3cm, 5cm, 12cm, 14cm, 15cm, 18cm, 20cm.
Tutoplast® Processed Fascia Lata is a solvent dehydrated, gamma-irradiated preserved human Fascia Lata. Recovery: All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
The processing of all Tutoplast® tissue consists of a strict, quality-controlled procedure, which involves thorough cleaning, processing, dehydration, and preservation. The process leaves no deleterious residue and minimizes antigenic potential. Additional assurance of sterility is achieved with the use of a target of 25 kGy (2.5 Mrads) of gamma radiation. Based on previous trials with gamma irradiation, the level used in the Tutoplast® process effectively significant adverse effect on the biomechanical properties of the tissue.
Tutoplast® Processed Fascia Lata is indicated for implantation with a specific spectrum of indications. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of native Fascia Lata, while providing the basic formative structure to support replacement by new endogenous tissue. This tissue is indicated for use in a variety of surgical applications, including duraplasty (as a substitute for human dura mater), and in abdominal, urological, ophthalmological, and vascular surgery.
- Implantation into areas with active or latent infection or signs of tissue necrosis.
- Implantation into areas with a compromised circulation.
- Any disorder which would create an unacceptable risk of post-operative complications.
- Tutoplast® Processed Fascia Lata remains sterile and non-pyrogenic as long as the package is not opened and/or damaged. The graft must be used before the expiration date.
- Appropriate placement and fixation are critical factors in the avoidance of potentially adverse effects on graft service life.
- The adsorption process and reformation of endogenous tissue begins one to two days after implantation and continues for weeks, months, or years, depending on the size of the graft and the responsiveness of the graft site.
Introduction and History
The exclusive Tutoplast® Process is a scientific and technology based method of virally inactivating, preserving and sterilizing human tissue for transplantation.
During the past thirty years, over 1 million Tutoplast® Bioimplants have been surgically implanted without a single documented case of disease transmission.
Stage 1: Materials – Source Screening Tutoplast® human tissues are obtained from tissue banks operating in compliance with recovery standards set forth by the Food& Drug Administration and the AATB (American Association of Tissue Banks). Serological protocols are followed as consistent with current U.S. FDA requirements (serological testing includes HIV 1 and 2, Hepatitis B and C, among others). Source material is rejected if medical and/or social history indicates risk of infectious disease, malignancy or other disease. The tissues are placed in prepared storage medium before the onset of processing. All tissues are unambiguously labeled and must pass standards for size, structure, cleanliness and quality. No donor pooling is allowed.
Stage 2: Osmotic Cleaning and Acellularization Tissues are cleaned with saline solution of various concentrations. The result is the osmotic destruction of cells, reducing the tissue to its fiber and mineral components. The results of osmotic contrast bathing phase:
- Removal of bacteria
- Potential viruses are exposed and prepared for activation in following phase
- Because the majority of antigens are bound to cell membranes, most of the antigenicity is removed.
Stage 3: Viral Inactivation and Denaturization Inorganic agents (hydrogen peroxide, sodium hydroxide) are employed in specific concentrations during specific time intervals shown to inactivate HIV and the agent responsible for Creutzfeldt-Jakob Disease (CJD).1 This denaturization of soluble proteins is achieved without significant alterations in the collagenous structure of the tissue.
1. Brown P, et al. Sodium hydroxide decontamination of Creutzfeld-Jakob Disease virus. The New England Journal of Medicine. Vol. 310, No.11.
Stage 4: Tissue Preservation The tissue is preserved by the extraction of water using organic solvents (acetone). Through this gentle method of preservation, the dense collagenous tissue matrix of the tissue is retained. The organic solvents employed in Phase 1 and 2 of the tissue processing are completely removed, resulting in a residue-free allograft. The organic solvents employed during this stage also possess disinfectant properties capable of inactivating HIV and other unconventional viruses.2
2. Hinton R, Jinnah RH, Johnson C, et al. A biomechanical analysis of solvent-dehydrated and freeze-dried human fascia lata allografts. Am J Sports Med 1992;20: 607-612.
Stage 5: Terminal Sterilization Following dehydration, the tissue is configured to standard sizes and packaged in transparent, double peel pouches. Finally, the each tissue is terminally sterilized by gamma-irradiation. Since viral inactivation is achieved during the previous stages, an appropriate dosage is employed for effective terminal sterilization of any remaining bacteria or bioburden without significant effects on the collagenous, fibril structure of the tissue.
- It is recommended that Tutoplast® Processed Fascia Lata be rehydrated prior to use by soaking in 0.9% saline solution for 5 to 30 minutes, depending on the consistency desired, using aseptic/sterile technique.
- Tutoplast® Processed Fascia Lata is packaged in various sizes (length and width). The size of the section used should correspond to the size of the respective defect.
- The surgeon should monitor the effect of rehydration by visual inspection after completing the rehydration and while cutting and shaping the allograft.
- Implantation should be preformed in such a way that the free edges of the implant do not extend into areas where the possibility of adhesion may present a problem.
- Absorbable or nonabsorbable suture material can be used to fix Tutoplast® Processed Fascia Lata.
- For a Continuous suture, absorbable suture material and round atraumatic needle are recommended.
- Suture gauge depends on the surgical indication.
- The suture should be located two to millimeters from the edge of the graft.
- Better results are obtained by doubling the section at suture sites that are under moderate to high stress.
- Tutoplast® Processed tissues have been used for over 25 years in more than 750,000 surgical transplant cases with an outstanding safety record. As with all biological products, it is not possible to give an absolute guarantee of freedom of transmitting infectious diseases such as hepatitis and CJD. Processed treatments shown to be capable of reducing the risk of any transmission as well as strict donor screening and laboratory testing are used to decrease the risk.
- The reaction of the body to any allograft is not completely understood.
- Discard all damaged or mishandled grafts or when possible contamination of the graft has occurred.
- Return all packages with flaws in the sterile barrier to the supplier.
- Unused tissue should be properly discarded.
- DO NOT RE-STERILIZE.
- Single patient use only.
- As with any surgical procedure, the possibility of infection exists.
- Although the Tutoplast® process is designed to eliminate antigenic properties of the graft, the possibility of rejection is present in any allograft procedure.
- Reoperation could be necessary to correct adverse effects.
- Adverse reactions should be immediately reported to Tutogen Medical, U.S., Inc.
This product should be stored in a clean, dry place at controlled room temperature of 15*C to 30* C (59* to 86* F).
- This graft has been sterilized by a target of 25 kGy (2.5 Mrads) of gamma radiation to provide sterility throughout the unit.
- The Packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product must be assumed nonsterile.
- Care should be taken to prevent contamination of the graft. In the event of such contamination, this product must be discarded.
- If the package has been opened, but the product is not used, the graft must not be resterilized and must therefore be discarded.
- 14 days post-op: The graft is incorporated at the level of the skeletal striated muscle. It is surrounded by well-vascularized, cell-rich, unspecified granulation tissue composed of macrophages and fibroblasts.
- 6 weeks post-op: The margins of the graft have become firmly incorporated in the host tissue where it has been replaced be cell-rich, well-vascularized endogenous connective tissue.
- 14 months post-op: The former graft site exhibits a defined, irritation-free, greyish-shite sheet of collagenous tissue corresponding to viable endogenous connective tissue. No immunological rejection has been observed.
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