STIMULAN®

STIMULAN is a pharmaceutical-grade calcium sulfate that is the perfect partner for your infection management strategy – helping you to improve surgical outcomes and lower overall costs of care.

 

Perfect partner for your infection management strategy

STIMULAN is a truly absorbable calcium sulfate precision engineered to complement your dead space management and infection management strategies.

  • Approved for placement at an infected site ¹

  • Uniquely engineered through our DRy26™ recrystallization method ²

  • Optimal absorption profile ³⁻⁸

  • May be mixed with antibiotics ¹

  • Predictable elution profile ⁹⁻¹⁰

  • No hydroxyaptite, insoluble impurities or PMMA debris ³⁻⁸

  • Does not cause third body damage ¹¹⁻¹³

  • Does not prevent use in articulating surfaces ¹¹⁻¹³

  • Does not act as a nidus for infection ³⁻⁸

  • Low levels of drainage ¹⁴
pellet-mould.png

Consistency is hard earned and uniquely achieved

There is no shortcut to perfection. Which is why we go the extra mile to bring you the exceptional performance characteristics of STIMULAN - all made possible though our proprietary DRy26™ methodology.

Each and every synthesis of STIMULAN undergoes a 26 step process that starts with pharmaceutical grade precursors and takes over 6 weeks to reach maturity.

Our unique DRy26™ recrystallization method dehydrates then rehydrates to precisely restructure the calcium sulfate. This ensures a uniform starting point from which the material is rebuilt under strictly controlled conditions for the highest level of consistency.

The result is as you would expect from the world’s leading expert in innovative calcium technologies.

Where others stop, we are just getting started

 

 

Frequently Asked Questions

 

STIMULAN is the perfect partner for your infection management strategy. It is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

References: 1. Biocomposites, STIMULAN Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. 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. 4. 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. 5. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. Journal of Clinical Rehabilitative Tissue EngineeringResearch., 2008. 12. 6. 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. 7. 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. 8. 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. 9. Aiken, S.S., et al., Local Release of Antibiotics for Surgical Site Infection Management Using High-Purity Calcium Sulfate: An In Vitro Elution Study. Surg Infect (Larchmt), 2014. 10. 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. 11. Cowie, R.M., et al., Influence of third-body particles originating from bone void fillers on the wear of ultra-high-molecular-weight polyethylene. Proc Inst Mech Eng H, 2016. 230(8): p. 775-83. 12. Cowie, R.M., et al., The Influence of Third Body Damage by a Calcium Sulfate Bone Void Filler on the Wear of Total Knee Replacements., in Orthopaedic Research Society Annual Meeting. 2016: Orlando, FL. p. 103. 13. Lewicki, K., et al., The Effect of Absorbable Calcium Sulfate on Wear Rates in Ultra-high-Molecular-weight Polyethylene: Potential Implications for Its Use in Treating Arthroplasty Infections. J Am Acad Orthop Surg, 2017. 14. 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.

For Indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit/ STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This brochure may include the use of STIMULAN or techniques that go beyond the current clearance/ approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2018, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP 18275044.8, US 15/933936

 

Recrystallised for improved clinical performance

STIMULAN has a unique crystal structure and properties.1,2

  • Controlled purity
  • May be mixed with liquid, powder and heat-sensitive antibiotics

Only STIMULAN undergoes a patented recrystallisation process that starts with pharmaceutical-grade reagents and results in its consistent and reliable performance.1–8

  • Predictable elution profile
  • Truly absorbable at an optimal rate
  • Low levels of drainage
  • No third body damage

Antibiotic elution from STIMULAN Rapid Cure9

antibiotic-elution.png 

Truly absorbable and totally synthetic calcium sulfate – absorbs at an optimal rate1–5,8
Leaves no nidus for infection.

post-op.png
Post-operative
1-month.png
1 month
2-weeks.png
11 weeks
6-months.png
6 months


Low levels of drainage2–3, 6–7, 10–12

Drainage rates-01-01.png

No third body damage13
Less scratching than competitor calcium sulfate and PMMA.

third-body-damage

STIMULAN does not damage total knee replacements when trapped between the articulating surfaces of the implant.

Frequently Asked Questions

 

STIMULAN is the perfect partner for your infection management strategy. It is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

References: 1. Biocomposites, STIMULAN Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. 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. 4. 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. 5. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. Journal of Clinical Rehabilitative Tissue EngineeringResearch., 2008. 12. 6. 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. 7. 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. 8. 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. 9. Aiken, S.S., et al., Local Release of Antibiotics for Surgical Site Infection Management Using High-Purity Calcium Sulfate: An In Vitro Elution Study. Surg Infect (Larchmt), 2014. 10. 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. 11. Cowie, R.M., et al., Influence of third-body particles originating from bone void fillers on the wear of ultra-high-molecular-weight polyethylene. Proc Inst Mech Eng H, 2016. 230(8): p. 775-83. 12. Cowie, R.M., et al., The Influence of Third Body Damage by a Calcium Sulfate Bone Void Filler on the Wear of Total Knee Replacements., in Orthopaedic Research Society Annual Meeting. 2016: Orlando, FL. p. 103. 13. Lewicki, K., et al., The Effect of Absorbable Calcium Sulfate on Wear Rates in Ultra-high-Molecular-weight Polyethylene: Potential Implications for Its Use in Treating Arthroplasty Infections. J Am Acad Orthop Surg, 2017. 14. 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.

For Indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit/ STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This brochure may include the use of STIMULAN or techniques that go beyond the current clearance/ approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2018, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP 18275044.8, US 15/933936

 

Case-by-case flexibility

STIMULAN can be used in three sizes of bead, as a paste or for injection, to optimise packing in bone and soft tissue. Its hydrophilic properties and options of rapid or standard setting times make it quick and easy if mixed with one or more antibiotics – helping you to adapt to each case as is merited.

 

pellets.png

Flexible formats to optimise dead space management

STIMULANPASTE VOLUMEBEAD VOLUMESETTING TIMEORDER CODES
KIT (standard setting)

Fully injectable paste
with individual bead kit
5 cc 10 cc

Approx.

8 minutes

600–005
10 cc 20 cc 600–010
         
Rapid Cure 

Rapid setting paste
with individual bead kit
5 cc 12 cc

Approx.

4 minutes

620–005
10 cc 25 cc 620–010
20 cc 50 cc 620–020

 

Frequently Asked Questions

 

STIMULAN is the perfect partner for your infection management strategy. It is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

References: 1. Biocomposites, STIMULAN Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. 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. 4. 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. 5. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. Journal of Clinical Rehabilitative Tissue EngineeringResearch., 2008. 12. 6. 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. 7. 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. 8. 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. 9. Aiken, S.S., et al., Local Release of Antibiotics for Surgical Site Infection Management Using High-Purity Calcium Sulfate: An In Vitro Elution Study. Surg Infect (Larchmt), 2014. 10. 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. 11. Cowie, R.M., et al., Influence of third-body particles originating from bone void fillers on the wear of ultra-high-molecular-weight polyethylene. Proc Inst Mech Eng H, 2016. 230(8): p. 775-83. 12. Cowie, R.M., et al., The Influence of Third Body Damage by a Calcium Sulfate Bone Void Filler on the Wear of Total Knee Replacements., in Orthopaedic Research Society Annual Meeting. 2016: Orlando, FL. p. 103. 13. Lewicki, K., et al., The Effect of Absorbable Calcium Sulfate on Wear Rates in Ultra-high-Molecular-weight Polyethylene: Potential Implications for Its Use in Treating Arthroplasty Infections. J Am Acad Orthop Surg, 2017. 14. 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.

For Indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit/ STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This brochure may include the use of STIMULAN or techniques that go beyond the current clearance/ approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2018, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP 18275044.8, US 15/933936

 

Transform outcomes

STIMULAN can transform outcomes in infected non-unions, osteomyelitis and periprosthetic joint infection.

 

xray1.gifTransform osteomyelitis in diabetic foot

Patient presented with: persistent osteomyelitis and interphalangeal joint destruction of left hallux. He was already receiving treatment for Charcot arthropathy to his right foot.

Outcome: 2 weeks post-operatively, the toe reduced in size. At the 16-month x-ray the patient was infection-free and amputation had been avoided. STIMULAN was seen to have completely absorbed at 4 months.

Click to read full case study

 

xray2.gifTransform infected trauma

Patient presented with: infected femoral nail and non-union of left femur with persistent discharging wounds proximally and distally.

Outcome: A 7 months follow-up there was a complete healing of the non-union and at 1 year patient remains infection free, walking with no pain.

Click to read full case study

 

xray3.gifTransform infected revision arthroplasty

Patient presented with: infected total knee replacement 2 years after primary procedure.

Outcome: A 1 year follow-up the patient remains infection free and is under regular follow-up.

Click to read full case study

 

 

Frequently Asked Questions

 

STIMULAN is the perfect partner for your infection management strategy. It is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

References: 1. Biocomposites, STIMULAN Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. 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. 4. 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. 5. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. Journal of Clinical Rehabilitative Tissue EngineeringResearch., 2008. 12. 6. 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. 7. 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. 8. 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. 9. Aiken, S.S., et al., Local Release of Antibiotics for Surgical Site Infection Management Using High-Purity Calcium Sulfate: An In Vitro Elution Study. Surg Infect (Larchmt), 2014. 10. 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. 11. Cowie, R.M., et al., Influence of third-body particles originating from bone void fillers on the wear of ultra-high-molecular-weight polyethylene. Proc Inst Mech Eng H, 2016. 230(8): p. 775-83. 12. Cowie, R.M., et al., The Influence of Third Body Damage by a Calcium Sulfate Bone Void Filler on the Wear of Total Knee Replacements., in Orthopaedic Research Society Annual Meeting. 2016: Orlando, FL. p. 103. 13. Lewicki, K., et al., The Effect of Absorbable Calcium Sulfate on Wear Rates in Ultra-high-Molecular-weight Polyethylene: Potential Implications for Its Use in Treating Arthroplasty Infections. J Am Acad Orthop Surg, 2017. 14. 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.

For Indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit/ STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This brochure may include the use of STIMULAN or techniques that go beyond the current clearance/ approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2018, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP 18275044.8, US 15/933936

 

Testimonials

Hear what surgeons have to say about STIMULAN

Dr Wassef case study

Infected hip revision with STIMULAN beads

Dr Webb case study

Bilateral high energy femoral fractures with STIMULAN beads

Technique Guide

See the STIMULAN Bullet Mat and Introducer in action

Dr Hohman case study

Tibial osteomyelitis with STIMULAN beads.

Testimonials

Hear what surgeons have to say about STIMULAN

Testimonials

Hear what surgeons have to say about STIMULAN

How to prepare

STIMULAN Rapid Cure with liquid and powder antibiotics