Global Regenerative Trade

MicroDTTect®

Implant infection control tool!

IMPROVE SENSIBILITY AND SPECIFICITY OF BIOFILM-RELATED INFECTIONS WITH MICRODTTECT BASIC METHODOLOGY[1], WITH COMPLETELY CLOSED DEVICE FOR HARVESTING, TRANSPORTING AND PROCESSING EXPLANTED SAMPLES TO DETECT BACTERIA

IMPLANT AND TISSUE INFECTIONS

IMPLANT MicroDDTect

Implant and tissue infections are a major threat and represent a significant burden in terms of a patient’s chances of recovery after a surgery of trauma.

Surgical site infections are associated with significant complications and an increase in mortality and length of stay. They are also a significant cost factor to health care systems around the world.

DETERMINING THE STRAIN OF BACTERIA ACTUALLY RESPONSIBLE FOR AN INFECTION IS ESSENTIAL TO DIAGNOSE AND TREAT THE INFECTION AND ANY RESISTANCE PRESENT.

Diagnosis implant and tissue infections is challenging: this is predominantly due to the nature of biofilm associated with the progress of an infection. Biofilm plays a particularly important role in implant and non-implant related infections.

Biofilm is a complex bacterial community protected by a self-produces that adheres to a living or inert surface. Bacteria settle on surfaces, adhere to them, actively multiply, forming colonies and create a highly viscoelastic matrix.

Biofilm makes the bacteria difficult to access for both the body’s own defense as well for antibiotics, and difficult to detect in diagnostic when using traditional microbiological methods.

Biofilm formation on medical devices is associated with hospital-acquired infections. Its high tolerance to antibiotics causes classical treatments lack efficacy, and removal of the biofilm-contaminated device is oEen the only therapeutic option.

it is also fundamentally important to avoid risks of contamination by other bacteria not directly responsible for the infection. Cross-contaminations play also a role in infection diagnosing.

An undiagnosed or incorrectly diagnosed infection has far-reaching consequences for the patient. They do not receive optimal treatment, which can lead to further complications and hospital stays and also impair their quality of life.

Moreover, every missed diagnosis has a cost. Costs related to misdiagnosis of PJI can be high and include direct costs, like the resulting wrong treatment and indirect costs, as for example the need for further treatments, the occurrence of further complications, the need for more prolonged hospitalization and the resulting work loss compensation and medico-legal claims, etc.…

DIAGNOSIS AND PATHOGEN IDENTIFICATION ARE CURRENTLY CONSIDERED THE BENCHMARK OF DIAGNOSIS OF PJI, BUT BOTH FALSE NEGATIVE (FN) AND FALSE POSITIVE (FP) RESULTS OF INTRA-OPERATIVE IDENTIFICATION OF THE PATHOGEN MAY TRIGGER EXTRA-COSTS.

Some study groups tried to find new diagnostic methods to detect bacteria responsible for implant-related and non-implanted-related infections:

DITHIOTHREITOL (DTT) can dissolve the polysaccharide matrix of the biofilm and detach the bacteria, helping identify bacteria strain, reducing false negative cultures.

IT IS ALSO NECESSARY THAT THE DIAGNOSTIC METHODS ALLOW TO AVOID CROSS-CONTAMINATIONS: TO PRESERVE SAMPLES FROM ANY CONTAMINATION IN EVERY SINGLE STEP (HARVESTING, TRANSPORTING, PROCESSING AND CULTURE) TO AVOID FALSE POSITIVE CULTURES AND DETECT BACTERIA ACTUALLY RESPONSIBLE FOR SURGICAL-SITE INFECTIONS.

THE SOLUTION FOR IMPLANT RELATED INFECTIONS

microDTTect is a completely closed device from the operating theatre to the microbiology laboratory, based on a new method of extracting bacteria and detaching bacterial biofilms[1] -​

microDTTect guarantees a successful result in all the key steps that lead to the diagnosis of explanted samples:

HARVEST the explanted samples to be analyzed under sterile and safe conditions

Place the explanted material inside the container and seal it closed (using the mini-grip and the additional clamp)

TRANSPORT the samples to be analyzed under sterile and safe conditions

Transport the device under safety conditions to the laboratory: the system is completely sealed closed and it can be transported minimizing the risk of contamination for the sample or the operator

PROCESS the sample s quickly under sterile conditions

The device remains closed throughout the process in the laboratory:

• Position the samples inside the device

• Remove the air from the chamber and close tight the device through the minigrip and the clamp for the second security closing

• Open the frangible red valve that connect the two chambers (the containment chamber and the DTT solution chamber) and press to let the DTT solution overflowing

• Place the device on the mechanical shaker for 15 minutes

• Open the frangible blue valve to connect the device containment chamber to the extraction system

• Withdraw the elute through the syringe and transfer it in the dedicated test tubes filling to the allowed maximum level

• Close the blue clamp for each tube, disconnect the tubes from the device and centrifuge them

• Connect a luer lock syringe to the red tube access and withdraw the supernatant

• Connect a second luer lock syringe to the blue tube access and resuspend the bacterial pellet, then withdraw it to perform cultures

AREAS OF USE

In all surgical procedures with a known or suspected infection, in particular:
ORTHOPAEDICS:
• Osteoarticular infection
• Prosthetic revisions:
       – Septic mobilization
       – Aseptic mobilization
• Revision of fixation devices
• Arthroscopy VERTEBRAL SURGERY
NEUROSURGERY
PLASTIC SURGERY 

HEART SURGERY

MAXILLOFACIAL SURGERY

VASCULAR SURGERY BIOPSIES
In all laboratory tests for isolating bacteria and/or detaching bacterial biofilms.

                        MEDICAL PROFESSIONALS

Areas of use of microDTTect system are all medical specialties involved in artificial or biologic implant. These could be hard or soft tissue samples. For example – heart valve could be treated, steel, carbon implants or any other material, breast implants, different stents.

MAXILLO- FACIAL SURGERY

CLICK ICON

CARDIAC SURGERY

CLICK ICON

ORTHOPEDICS

CLICK ICON

Plastic Surgery

Infected implants can be treated with the Microddect system and infection taken under control!

REGENERATIVE NEUROLOGY

CLICK ICON

SPINE SURGERY

CLICK ICON

SUPPORTING EVIDENCE

PUBLICATIONS

Calori 2015 comparative evaluation of MicroDTTect

Drago_Clinical Orthopaedics and Related Research_2012

Drago_Journal of Orthopedic Research_2013

Breast biofilm

Prosthetic joints: shining lights on challenging blind spots 
Kordo Saeed 1, Matthew Dryden 2, Matteo Bassetti 3, Eric Bonnet 4, Emilio Bouza 5, Monica Chan 6, Nick Cortes 7, Joshua S Davis 8, Silvano Esposito 9, Gérard Giordano 10, Ian Gould 11, David Hartwright 12, David Lye 13, Mercedes Marin 5, Rhidian Morgan-Jones 14, Francisco Lajara-Marco 15, Elda Righi 3, Carlo Luca Romano 16, John Segreti 17, Serhat Unal 18, Rhodri Llywelyn Williams 19, Ata Nevzat Yalcin 20, International Society of Chemotherapy

 

Drago L, De Vecchi E, Bortolin M, Zagra L, Romanò CL, Cappelletti L. Epidemiology and Antibiotic Resistance of Late Prosthetic Knee and Hip Infections. J Arthroplasty. 2017 Aug;32(8):2496-2500. doi: 10.1016/j.arth.2017.03.005. Epub 2017 Mar 15. PMID: 28390886.

De Vecchi E, Bottagisio M, Bortolin M, Toscano M, Lovati AB, Drago L. Improving the Bacterial Recovery by Using Dithiothreitol with Aerobic and Anaerobic Broth in Biofilm-Related Prosthetic and Joint Infections. Adv Exp Med Biol. 2017;973:31-39. doi: 10.1007/5584_2016_51. PMID: 27401077.

 

Calori GM, Colombo M, Navone P, Nobile M, Auxilia F, Toscano M, Drago L. Comparative evaluation of MicroDTTect device and flocked swabs in the diagnosis of prosthetic and orthopaedic infections. Injury. 2016 Oct;47 Suppl 4:S17-S21. doi: 10.1016/j.injury.2016.07.040. Epub 2016 Aug 1. PMID: 27492065.

Use of Dithiothreitol to Dislodge Bacteria From the Biofilm on an Aortic Valve in the Operating Theatre: A Case of Infective Endocarditis Caused by Staphylococcus aureus and Proteus mirabilis

USE OF AN INNOVATIVE SYSTEM FOR TRANSPORT AND TREATMENT OF IMPLANTS AND BIOPSIES FOR DIAGNOSIS OF BONE AND JOINT INFECTIONS
E. De Vecchi, V. Signori, M. Bortolin, C. Romanò, L. Drago

J Antimicr Chem 2015

JAC 2014

JOR 2013

Biomed Res Int 2013

CORR 2012

 OrthoAcademy (interview in Italian)

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THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS: