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Don't leave serious infection risks unmanaged
Meet Simini.
Don't leave serious infection risks unmanaged
Meet Simini.
Don't leave serious infection risks unmanaged
Meet Simini.
Protect your patients from resistant bacteria & biofilms - because saline and post-op antibiotics are not effective
Protect your patients from resistant bacteria & biofilms
- because saline and post-op antibiotics are not effective
- because saline and post-op antibiotics are not effective
Get Started In Less Than 60 Seconds
- Non-antibiotic with no known resistance
- 5 Levels of Supporting Evidence
- Used in primary and revision surgeries
- Learn More In The Video Below And Sign Up For Free Today!
Only takes one minute for a surgeon to
add intra-op protection
Only takes one minute for a surgeon to
add intra-op protection
So, Why Simini?
Many surgeons are shocked to find out that their patients are not protected from biofilms and resistant bacteria when they use saline and post-op antibiotics.
That’s Where Simini Comes In.
Why leave these risks and unmanaged? Just apply Simini Protect Lavage for one minute. Biofilms and resistant bacteria can be removed, and you can reduce two significant sources of infection.
According to the experience of the authors, Simini Protect Lavage was a highly effective medical device, that allowed the prevention of infection in surgeries with higher risk of infection and moreover it allowed for the eradication of infections without the need to remove implants when performing surgical revisions in a single stage. (1)
According to the experience of the authors, Simini Protect Lavage was a highly effective medical device, that allowed the prevention of infection in surgeries with higher risk of infection and moreover it allowed for the eradication of infections without the need to remove implants when performing surgical revisions in a single stage.(1)
Scroll down to see the 5 Levels of Evidence
supporting the use of Simini Protect Lavage in your practice
Scroll down to see the 5 Levels of Evidence supporting the use of Simini Protect Lavage in your practice
The Simini Advantages
- Locally Administered Product vs. systemically
- Applied at time of highest risk (during surgery)
-
Short Product Exposure: Aligned with international guidelines
- Non-antibiotic product and no new techniques
- Published studies of clinical outcomes (see below)
Get Started In Less Than 60 Seconds
Evidence Level #1
Bacteria removal with Simini
Evidence Level #1
Bacteria removal with Simini
Simini Protect Lavage has been evaluated in laboratory studies, clinical studies and case studies
In clinical and laboratory studies, Simini Protect Lavage removed 99.98% of bacteria (2), (3)
- Key Fact: Laboratory studies with have shown Simini Protect Lavage removed 99.98% of bacteria whether biofilms were present or not
- So Simini Protect Lavage can be broadly used across your orthopedic surgical caseload
- Perfect complement to a multi-modal infection control protocol adding targeted removal of resistant bacteria and biofilms
- Simini Protect Lavage is the identical fluid to Zimmer's Bactisure for human surgery
(2) Hunter et al., “Clinical Effectiveness of a Biofilm Disrupting Surgical Lavage in Reducing Bacterial Contamination in Total Knee Arthroplasty Revision Surgery in Known Cases of Prosthetic Joint Infection”, Zimmer Biomet white paper. (administered 1 litre volume via pulsed jet lavage)
(3) O’Donnell J, Wu M, Cochrane N, Belay E, Myntti M, James G, Seyler T, “Efficacy of Common Antiseptic Solutions Against Clinically Relevant Planktonic Microorganisms,” Orthopedics (2022)
Evidence Level #2
Simini compared to saline
Evidence Level #2
Simini compared to saline
Texas Tech University
Murine surgical model after inoculation with
MRSA (Methicillin-resistant staph. aureus) or Pseudomonas Aeruginosa (5)
Simini demonstrates significant reduction in bacteria compared to saline
- Sham surgery on a rodent's back
- Inoculate with either MRSA or Pseudomonas and wait 40-60 minutes to simulate surgery time
- Lavage the wound with saline, Simini or positive control
- Excise tissue to count the number of bacteria present
Simini compared to povidone iodine and chlorhexidine
Evidence Level #3
Simini compared to povidone iodine and chlorhexidine
Simini Protect Lavage demonstrated the overall greatest efficacy of all the agents studied. (4)
Published independent studies
- O'Donnell et al. compares planktonic bacteria removal (bacteria with no biofilms present) (3)
- Kia et al. compares bacteria removal with biofilms present (4)
- Evaluates removal of Staph Aureus, Pseudomonas and other bacteria
- Simini Protect Lavage is the identical solution to Zimmer's Bactisure for human surgeons
(3) O’Donnell J, Wu M, Cochrane N, Belay E, Myntti M, James G, Seyler T, “Efficacy of Common Antiseptic Solutions Against Clinically Relevant Planktonic Microorganisms,” Orthopedics (2022)
(4) Kia C, Cusano A, Messina J, Muench LN, Chadayammuri V, McCarthy MB, Umejiego E, Mazzocca AD, “Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis”, Journal of Shoulder and Elbow Surgery (2021)
Evidence Level #4
Veterinary Clinical Study
Evidence Level #4
Veterinary Clinical Study
Study Design:
Patients were selected because they were at a high risk of infection or were revision cases, where an infection was present.
For each surgery, there was a swab to culture for bacteria just after the opening of the surgery. The procedure was then performed, and then just prior to suturing, the surgical wound was lavaged with Simini Protect Lavage. Following this lavage, a second swab was taken for analysis.
The patient was sutured, and follow-up occurred for all patients 6 months following the study.
Study Conclusion
- According to the experience of the authors, Simini Protect Lavage was a highly effective medical device, that allowed the prevention of infection in surgeries with higher risk of infection and moreover it allowed for the eradication of infections without the need to remove implants when performing surgical revisions in a single stage. (1)
(1) I. Forzisi, L. Vezzoni, M. Bozzerla, A.Vezzoni “Intraoperative Antiseptic Lavage with Simini for Prevention and for Treatment of SSI.” European Society of Veterinary Orthopaedics and Traumatology Meeting, Sept 24, 2022
Evidence Level #5
Human Clinical Study
Human Clinical Study
Study Design:
A human clinical study was performed in 45 patients with a total knee replacement and a periprosthetic joint infection.
During the revision surgery, just prior to closing, a sample was taken from the surgical wound, the wound was lavaged with Simini Protect Lavage, and then a subsequent sample was taken thereafter.
These patients were then followed-up at 3 months post surgery which is consistent with W.H.O. guidelines.
Results (2):
- Application of the Simini Protect Lavage demonstrated a 99.98% removal of bacteria in the wound
- 90 Day post-surgery infection rate was observed to be 38% lower than historical controls
(2) Hunter et al., “Clinical Effectiveness of a Biofilm Disrupting Surgical Lavage in Reducing Bacterial Contamination in Total Knee Arthroplasty Revision Surgery in Known Cases of Prosthetic Joint Infection”, Zimmer Biomet white paper. (administered 1 litre volume via pulsed jet lavage)
Safety Studies
Safety Studies
- Completed safety studies required for human medical device clearance (6),(7)
- Successful studies have demonstrated Simini Protect Lavage compatibility with orthopedic implants and materials
Still not convinced...
Review veterinary case studies with Simini Protect Lavage
In these studies,
Simini Protect Lavage has been tested
by veterinary surgeons
in tough clinical situations
to give you the confidence
of its benefit
across your surgical practice
has been tested
by veterinary surgeons
in tough clinical situations
to give you the confidence
of its benefit
across your surgical practice
In these studies, Simini Protect Lavage has been tested by veterinary surgeons
in tough clinical situations
to give you the confidence
of its benefit across your surgical practice
Get Started In Less Than 60 Seconds
Veterinary Case Studies
Veterinary Case Studies
- Orthopedic Surgeries
- Emergency Procedures
- Fracture Repair
-
Wounds
Not sure where to use Simini
- Simini Protect Lavage can be used for most types of surgical orthopedic procedures.
- Simini Protect Lavage cannot be used in the eyes and ears, abdomen and thorax.
- Orthopedic Surgeries
- Emergency Procedures
- Fracture Repair
-
Wounds
Biofilms, Bacteria & Simini
- Biofilms form quickly: In as little as 20 minutes (less than the time for an average TPLO procedure)
- Bacteria more resistant: Up to 1000X more resistant when in biofilm
- Removed 99.98% of bacteria: Clinical trial result with Simini Protect Lavage fluid (1)
Proudly show how you are a
"Sustainable Vet"
- Demonstrate to clients how you provide addition protection for their pet by using Simini Protect Lavage
- How using non-antibiotic Simini Protect Lavage is an important step for responsible antibiotics use
- Clients value products that protect their pet, while protecting human medicines in a sustainable way
Frequently Asked Questions
How are these products different from current veterinary offerings?
Bacteria create biofilms to protect themselves. Simini Protect Lavage allows you to remove biofilm and expose bacteria for optimal removal.
What is in Simini Protect Lavage?
The Simini Protect products have a patented formulation of ingredients. Simini Protect Lavage contains ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.
What types of efficacy studies have been performed?
These products have been evaluated in a veterinary clinical study(1), independent laboratory tests (3,4), biofilm tests (4), animal models and a human clinical study (2).
What types of procedures can they be used for and not used for?
The Simini Protect Lavage can be used for orthopedic surgeries and in the cases of trauma, emergency in the veterinary clinic.
The Simini Protect Lavage cannot be used in the eyes or ears or in the abdomen or thorax.
How do you use the Simini Protect Lavage?
Just prior to suturing, lavage with the Simini Protect Lavage as you would with normal saline. The solution is then rinsed with copious amounts of saline, as surgeons usually lavage wounds. See product label for full details.
What types of safety studies have been performed??
The Simini Protect Lavage has completed all the necessary safety testing to achieve human medical device product clearance.
If I have questions, is there someone I can talk to?
Yes. Email cd@simini.com or call +1 (647) 292-4920 anytime.
Studies & References
- I. Forzisi, L. Vezzoni, M. Bozzerla, A.Vezzoni “Intraoperative Antiseptic Lavage with Simini for Prevention and for Treatment of SSI.” European Society of Veterinary Orthopaedics and Traumatology Meeting, Sept 24, 2022
- Hunter et al., “Clinical Effectiveness of a Biofilm Disrupting Surgical Lavage in Reducing Bacterial Contamination in Total Knee Arthroplasty Revision Surgery in Known Cases of Prosthetic Joint Infection”, Zimmer Biomet white paper. (administered 1 litre volume via pulsed jet lavage)
- O’Donnell J, Wu M, Cochrane N, Belay E, Myntti M, James G, Seyler T, “Efficacy of Common Antiseptic Solutions Against Clinically Relevant Planktonic Microorganisms,” Orthopedics (2022)
-
Kia C, Cusano A, Messina J, Muench LN, Chadayammuri V, McCarthy MB, Umejiego E, Mazzocca AD, “Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis”, Journal of Shoulder and Elbow Surgery (2021)
- Data on file
- ISO Intramuscular Implantation Test with Histopathology (14 Day Rabbit Study)- Simini Protect Lavage - No abnormal clinical signs, Lavage was considered "Non-Irritant" compared to predicate device.
- Dermal Testing - Uninfected wounds (14 Day Porcine Study) Simini Protect Lavage resulted in normal wound healing and was comparable to a predicate device.
