STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (2023)

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STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (1)

Biocomposites anuncia el Marcado CE para STIMULAN®

La primera matriz de calcio en recibir aprobación europea como portador de antibióticospara uso en huesos y tejidos blandos

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (2)

STIMULAN®

Diseñado de forma única para cumplir con las demandas de precisión y control

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (3)

Bullet Mat and Introducer

Diseño aerodinámico y flexible que facilita el suministro de STIMULAN

Library Videos Productos

El complemento perfecto para su estrategia de manejo de infecciones

STIMULAN es un portador de antibióticos de sulfato de calcio completamenteabsorbible – especialmente diseñado para apoyar la gestión proactiva del espaciomuerto y la infección en el sitio quirúrgico con una flexibilidad sin igual y la aplicaciónquirúrgica más amplia.1

  • la única matriz de calcio aprobada para su uso en huesos y tejidos blandos
  • aprobada para ser mezclada con vancomicina, gentamicina y tobramicina
  • se puede aplicar directamente en presencia o ausencia de infección

Mantenga el reto de la infección bajo su control

Con la capacidad de mezclar sustancias según las necesidades antimicrobianas específicas de cada infección, STIMULAN combina flexibilidad con la previsibilidad y consistencia necesarias para garantizar una cobertura antibiótica sostenida.

Propiedades que impulsan el redimiento

La configuración y construcción única del cristal de STIMULAN cuenta con su propio conjunto de cualidades para respaldar en casos de infección.2

  • Nivel de pH fisiológico
  • Grado de pureza controlada
  • Sin hidroxiapatita, impurezas insolubles o residuos de PMMA
  • Se mezcla fácilmente con antibióticos líquidos y en polvo

Vea cómo STIMULAN marcará la diferencia en sus casos

  • Perfil de elución supra terapéutico predecible3
  • flexibilidad para ajustar el antibiótico a la necesidad clínica4
  • acción demostrada contra el biofilm5
  • absorción completa a un índice óptimo1,6-11
  • Bajos niveles de drenaje12-18
  • No causa daño a terceros19,20
  • No impide su uso en superficies articuladas19-20
  • No deja nidos para la infección6-11
Perfil de elución supra terapéutico predecible3

Niveles de antibióticos mantenidos por encima de la concentración mínima inhibitoria durante más de 40 días

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (6)

Flexibilidad para adaptar los antibióticos a las necesidades clínicas4

Eficaz contra un amplio espectro de patógenos

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (7)

Acción demostrada contra el biofilm5

No se recuperaron organismos viables en el biofilm preestablecido

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (8)

Bajos niveles de drenaje12-18

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (9)

Sulfato de calcio verdaderamente absorbible y totalmente sintético, con un índice óptimo de absorción1,6-11

No deja nidos para la infección

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (10)

Postoperatorio

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (11)

1 mes

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (12)

11 semanas

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (13)

6 meses

No daña la superficie de las articulaciones19,20

Menor efecto de rallado que el sulfato de calcio de la competencia

STIMULAN no daña la artroplastia total de rodilla cuando se encuentra localizado entre las superficies articulares del implante

Imágenes microscópicas (x6.5) del deterioro de una placa de cobalto-cromo mediante simulación experimental (360,000 ciclos) con partículas de un tercer cuerpo atrapadas entre la placa y un clavo UHMWPE de la articulación.

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (14)

STIMULAN

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (15)

Sulfato de calcio competidor

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (16)

Control

Evidencia y conocimientos técnicos inigualables que proporcionan confianza

Con nuestro conocimiento especializado, dedicación y experiencia líderes en la industria, puedeestar seguro de que se cumplirá el alto nivel de consistencia que exigen sus casos.

La consistencia se consigue con determinación y se logra de manera única

STIMULAN está exclusivamente diseñado a travez de nuestro proceso de recristalización DRy26.2 Cada síntesis se somete a un proceso de 26 pasos que comienza con precursores de grado farmacéutico y tarda mas de 6 semanas en alcanzar la madurez.

 

Flexibilidad caso por caso

Cada parte de STIMULAN ha sido diseñada para proveer simplicidad, flexibilidad intraoperatoria y resultados óptimos. Disponible en una variedad de presentaciones, todas eficazes y con rápido tiempo de fraguado.

STIMULAN® products

STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (19)

STIMULAN® Bullet Mat and Introducer

Dispositivo innovador que facilita el suministro del producto en las zonas de difícil acceso.

  • Las balas son alargadas con una ranura a un lado para reducir el riesgo de presión en la zona del defecto.
  • Las balas pueden prepararse en dos diámetros – 7mm y 9mm
STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (20)

STIMULAN® Rapid Cure

Pasta de fraguado rápido con un kit de perlas individual.

  • Las perlas pueden prepararse en tres tamaños; 3, 4.8 and 6mm
  • Disponible en 5cc, 10cc y 20cc (volumen en perlas 12cc, 25cc and 50cc)
  • Tiempo de fraguado rápido aprox. 4 minutos
STIMULAN® | Perlas De Sulfato De Calcio | Biocomposites (21)

STIMULAN® Kit

Pasta totalmente inyectable con un kit de perlas individual.

  • Las perlas pueden prepararse en tres tamaños; 3, 4.8 and 6mm
  • Disponible en 5cc y 10cc (volumen en perlas 10cc and 20cc)
  • Tiempo de fraguado estándar aprox. 8 minutos

STIMULAN - Poder para transformar los resultados

01:16

Escuche la opinión del Dr. Casas acerca de STIMULAN

01:38

STIMULAN Bullet Mat and Introducer - Guía técnica

04:19

Cómo preparar STIMULAN Rapid Cure con antibióticos en polvo y liíquidos

06:22

Caso práctico del Dr Hohman - Articulación de rodilla infectada

04:04

Caso práctico del Dr Wassef - Revisión de Artroplastia Total de Cadera infectada

03:18

Caso práctico del Dr Webb - Fractura bilateral femoral

03:22

Escuche las opiniones de cirujanos acerca de STIMULAN

03:52

Library

A continuación se enumeran 4 de los artículos más relevantes para esta especialidad, pero hay mucha más evidencia inigualable para explorar en nuestra página de Evidencia.

Explore Library

STIMULAN® Transformación de la osteomielitis por estreptococos del grupo B y MRSA Ver caso práctico >
STIMULAN® Transformación de traumas infectados Ver caso práctico >
STIMULAN® Transformación de artroplastias de revisión infectadas Ver caso práctico >
STIMULAN® Transformación de la osteomielitis en pie diabético Ver caso práctico >

Referencias y advertencias legales

1.Biocomposites, STIMULAN Rapid Cure/Kit Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. Cooper, J.J., S.S. Aiken, and P.A. Laycock, Antibiotic stability in a synthetic calcium sulphate carrier for local delivery, in 32nd annual meeting of the European Bone and Joint Infection Society. 2013: Prague, Czech Republic. 4. Laycock, P., et al., In Vitro Efficacy of Antibiotics Released from Calcium Sulfate Bone Void Filler Beads. Materials, 2018. 11(11): p. 2265. 5. Delury, C., et al., Determining the Efficacy of Antibiotic-loaded Calcium Sulfate Beads against Pre-Formed Biofilms: An In Vitro Study, in ASM Microbe. 2019: San Francisco, USA.Somasundaram, K., et al., Proximal humeral fractures: the role of calcium sulphate augmentation and extended deltoid splitting approach in internal fixation using locking plates. Injury, 2013. 44(4): p. 481-7. 7. Lei, D., et al., Treatment of Distal Radius Bone Defects with Injectable Calcium Sulphate Cement., in Bone Grafting, A. Zorzi, Editor. 2012, InTech. p. 125-134. 8. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH., 2008. 12. 9. Lei, D., Z. Ma, and X. Jing, Treatment of bone defect with injectable calcium sulfate powder in distal fractures of radius. Chinese Journal of Bone Tumor and Bone Disease, 2007. 10. Aiken, S.S., J.J. Cooper, and S. Zhou, Osseointegration of a calcium sulphate bone substitute in a large animal model, in The 5th International Congress of Chinese Orthopaedic Association. 2010: Chengdu, China. 11. Lazarou, S.A., G.B. Contodimos, and I.D. Gkegkes, Correction of alveolar cleft with calcium-based bone substitutes. J Craniofac Surg, 2011. 22(3): p. 854-7. 12. McPherson, E.J., M.V. Dipane, and S.M. Sherif, Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection and Revision Arthroplasty. The Use of Synthetic Pure Calcium Sulfate (Stimulan®)Impregnated with Vancomycin & Tobramycin. Reconstructive Review, 2013. 3(1): p. 32-43. 13. McPherson, E.J., Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection. The Use of Synthetic Pure Calcium Sulfate (Stimulan®) Impregnated with Vancomycin & Tobramycin, in 2nd Annual Oxford Bone Infection Conference (OBIC). 2012: Oxford, UK. 14. Gauland, C., The use of antibiotic impregnated, implanted synthetic calcium sulphate tablets in the treatment of soft tissue, vancomycin resistant, enterococcus infections, in The Symposium on Advanced Wound Care and Wound Healing Society Annual Meeting. 2011: Gaylord Texan Hotel & Convention Center, Dallas, Texas. 15. Borrelli, J., Jr., W.D. Prickett, and W.M. Ricci, Treatment of nonunions and osseous defects with bone graft and calcium sulfate. Clin Orthop Relat Res, 2003(411): p. 245-54. 16. Helgeson, M.D., et al., Antibiotic-impregnated calcium sulfate use in combat-related open fractures. Orthopedics, 2009. 32(5): p. 323.McKee, M.D., et al., The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma, 2002. 16(9): p. 622-7. 18. Noor, S., et al., The use of Osteoset-T in the treatment of chronic osteomyelitis of the tibia following exogenous trauma: A review of 22 patients at a regional trauma centre. Bone & Joint Journal Orthopaedic Proceedings Supplement, 2013. 95-B(SUPP 23): p. 4. 19. Analysis of the Wear Effect 3rd Body Particulate (Bone Cement) has on UHMWPE, Accutek Testing Laboratory, Fairfield OH, K13107732-1, 2014. 20. Cowie, R.M., et al., The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res, 2019. 8(2): p. 65-72.

Siga las indicaciones y consulte las contraindicaciones, advertencias y precauciones en las instrucciones de uso. Es responsabilidad del especialista decidir el tipo y la cantidad de antibiótico empleado. El uso simultáneo de antibióticos administrados localmente podría afectar al tiempo de fraguado.

La práctica de mezclado de antibióticos con el dispositivo STIMULAN Kit / STIMULAN Rapid Cure no ha sido evaluada por ninguna autoridad competente europea de medicamentos y está considerada como una indicación no autorizada conforme a las especificaciones del medicamento. Realizar esta práctica corre por cuenta y riesgo del cirujano / profesional sanitario.

Este catálogo puede contener el uso de STIMULAN y/o técnicas que van más allá de la autorización / aprobación actual concedida por la autoridad reguladora competente. Para obtener más información, póngase en contacto con su representante local.

©2019, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes y Dry26 son marcas / marcas registradas de Biocomposites Ltd. Todos los derechos reservados. No está permitida la copia, reproducción, distribución o reedición sin el permiso expreso y por escrito del propietario, Biocomposites Ltd.

Patentes concedidas: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1 / Patentes pendientes: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP18275044.8, US 15/933936, CN 108619579A

MA0048R3/MA0252R1/MA0093R3/MA0238R1

FAQs

What are the directions for STIMULAN? ›

powder and mix Add STIMULAN Rapid Cure mixing solution and mix for 30 seconds Apply to bead mat immediately Sets in 3-5 minutes CAUTION: The mixing solution provided in the pack should be used. Do not add any other fluid.

How long does it take for antibiotic beads to dissolve? ›

Within six weeks, the microspheres are completely dissolved and leave nothing behind in the joint that could lead to future problems for the patient.”

What antibiotics are used for STIMULAN beads? ›

Vancomycin and tobramycin were used to treat the infection. 6 months after treatment the patient was free from infection, fully weight-bearing and without restrictions on activity – with complete absorption of STIMULAN paste.

Is STIMULAN an implant? ›

STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4. 2H2O) that resorbs and is replaced with bone during the healing process.

What are the benefits of STIMULAN? ›

Dr. Sassoon: I think the economic benefits of STIMULAN are simply a decrease in a risk of revision in an arthroplasty setting. You're potentially decreasing your risk of infection or wound healing problems that may be related to infection, either around an implant or in the soft tissue envelope surrounding an implant.

What are the complications of STIMULAN? ›

Stimulan-specific complications included wound drainage, HO and hypercalcaemia.

What happens when antibiotics wipe out good bacteria? ›

Researchers say some antibiotics, including commonly prescribed tetracyclines and macrolides, can kill healthy gut bacteria during use. They said the lack of healthy gut bacteria can lead to gastrointestinal ailments and recurring infections.

How long does it take for good bacteria to restore after antibiotics? ›

Typically, it will take the body time to balance the microbiome to healthy, diverse bacteria levels. In fact, research shows that it takes about 6 months to recover from the damage done by antibiotics. And even then, the body might not even be back to its pre-antibiotic state.

Do you have to remove antibiotic beads? ›

This suggest that If PMMA antibiotic beads are placed in areas with minimal overlying subcutaneous tissue, patients may present with persistent pain. In these scenarios, it is reasonable to remove the beads to reduce pain and prevent skin irritation.

Where do you place antibiotic beads? ›

A chain of antibiotic beads is placed in the wound, especially in the dead space of bone loss.

Is STIMULAN absorbable? ›

Truly absorbable and totally synthetic calcium sulfate – absorbs at an optimal rate.

How long do antibiotic spacers stay in? ›

In most two-stage revisions, an antibiotic-loaded spacer usually is placed in position for 6 to 12 weeks before the final prosthesis is implanted [7, 10, 19, 23].

What is the best antibiotic for dental implant? ›

Use a loading dose of antibiotics one day prior to the surgery (ensuring adequate levels in sinus tissues before surgery) and a beta-lactamase antibiotic, penicillin (Augmentin is the best choice), and cephalosporin for five days due to the high incidence of beta-lactamase pathogens in maxillary sinus infections.

Why use Arestin around implants? ›

Arestin is a sustained presence antibiotic that was placed to assist in the elimination of a significant inflammatory process localized around your implant(s) and/or teeth. The major benefits of using Arestin rely on its sustained presence in the site.

What is STIMULAN antibiotic impregnated beads for the treatment of diabetic foot infection? ›

Stimulan®, an antibiotic loaded absorbable calcium sulfate biocomposite, was used to treat persistent diabetic foot infection with chronic osteomyelitis. Staphylococcus aureus was the most common bacteria isolated.

How do you use antibiotic beads? ›

A string of antibiotic beads is placed into the wound for dead space management and to provide a high concentration of local antibiotic to the wound. Figure 2: In open fractures with significant softtissue injuries, antibiotic beads can be placed in the open wound.

How much is antibiotic beads? ›

The average cost of antibiotic bead treatment per patient was $419.36 for Group 1 and $484.54 for Group 2.

What are antibiotic impregnated calcium sulfate beads? ›

Background. Dissolvable antibiotic-loaded calcium sulfate beads are used as an intraoperative adjunct during debridement with antibiotics and implant retention (DAIR) for periprosthetic joint infections (PJI) to reduce the historically higher failure rates than one- or two-stage exchange.

What are the side effects of prolonged antibiotic therapy? ›

Long term side effects of antibiotics

Additional research also found that prolonged exposure to antibiotic therapy has associations with an increased risk of gastrointestinal issues in premature babies, late-onset sepsis, or death among very low birth weight infants.

What are the side effects of antibiotics on the brain? ›

Overall, antibiotics increase the prevalence of both depression and anxiety. Rarely, they can also cause psychotic disorders with a schizophrenia-like picture. Although most patients taking antibiotics do not suffer from an iatrogenic psychiatric disorder, some do, and as clinicians, we need to keep this in mind.

What are serious antibiotic side effects? ›

When antibiotics aren't needed, they won't help you, and the side effects could still hurt you. Common side effects of antibiotics can include rash, dizziness, nausea, diarrhea, or yeast infections. More serious side effects include Clostridioides difficile infection (also called C. difficile or C.

What naturally kills bad bacteria in the gut? ›

An anti-inflammatory diet, regular exercise, good quality sleep, and probiotics are all strategies to put in place before trying antimicrobials or antibiotics to get rid of bad bacteria.

What kills good gut bacteria? ›

Processed foods, as well as alcohol, can also negatively impact gut health. Prebiotic and probiotic foods like whole grains, onions, garlic, fermented foods, miso and yogurt feed the good bacteria in your gut.

What are the 3 super foods for your gut? ›

The Best Superfoods For Gut Health
  • Leafy Greens. Leafy greens are a powerful prebiotic and are high in vitamins C, K, B complex, folic acid, beta carotene, iron, iodine, calcium, potassium, magnesium, sulphur and chlorophyll. ...
  • Asparagus. ...
  • Oats. ...
  • Greek Yoghurt. ...
  • Apples. ...
  • Ginger.

Can a bacterial infection come back after antibiotics? ›

Once the antibiotic treatment ends, the few remaining bacteria can grow again, restoring the infection. Infections that can't be treated are a significant problem.

Do infections come back stronger after antibiotics? ›

Overuse of antibiotics is creating stronger germs. Some bacteria are already "resistant" to common antibiotics. When bacteria become resistant to antibiotics, it is often harder and more expensive to treat the infection.

What to avoid while on antibiotics? ›

What Not to Eat while Taking Antibiotics
  • Foods high in acidity. Highly acidic foods repel absorption of drugs in our body. ...
  • Allergens and sugars. Gluten, dairy, and sugar are common allergens which suppress the ability of our white blood cells to destroy bacteria. ...
  • Dairy products. ...
  • Foods high in fiber. ...
  • Alcohol.
Jan 12, 2018

What happens to bacteria when you do not finish taking your antibiotics? ›

If you stop treatment before the antibiotic cycle is over, the remaining bacteria can continue to multiply. If these bacteria become resistant to the antibiotics, they can potentially do even more harm. It may take longer for you to recover from your illness, and your physician may have to prescribe more medication.

What happens if you don't finish a round of antibiotics? ›

If an antibiotic prescription is not finished, you could become sick again, according to the CDC. This could happen because you're feeling better and you might think you are over an infection. But, some of the bacteria may still be hanging on in your body.

Do antibiotics strip good bacteria? ›

Unfortunately, antibiotics don't stop at only killing bad bacteria. Instead, antibiotics kill good bacteria too. So antibiotics affect your entire microbiome.

What are the indications for STIMULAN? ›

STIMULAN can be used in cases with an infected site to fill a bone void or defect created by a cyst, tumor, traumatic injury or osteomyelitis. Patient presented with: infected femoral nail and non-union of left femur with persistent discharging wounds proximally and distally.

References

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