The discovery of bacteria was followedf by that of antibiotics, but infections remain rife. Thought must be given to the mechanisms leading to the onset of infection. To reduce the frequency of infections, fundamental research must be developed. Several avenues will be explored.

In progress

 

The structural design and functioning of the operating theatre must seek to combat nosocomial infections. This fight begins as of the design phase :

The actual design is, of course, done by technical experts in terms of each component involved – air, water, surface, volume, but the presence of all the future users of the operating theatre, to assist in its design, is indispensible ;

A rigorous, consistent approach is required from the very beginning.

If water and air circuits meet the standards that apply to the surgery involved, checks and controls are embedded in the icalin score, dirty and clean material circuits and transport are coded and constantly reassessed, the use of surfaces that can be biocleaned is the norm, cleaning controls are one of the goals of a « Clin », all the stages in instrument and material sterilisation are respected, and traceability is mandatory,

Then standards and technical controls have gradually been introduced and will be constantly enhanced.

But what about human controls ? Medical and social hierarchies occasionally seem to act as a break. Training in hygiene is mandatory at nursing school but is not part of a doctor or surgeon's curriculum..

An evaluation of nursing staff and Inciso type network study procedures raise awareness of the need for controls, but more among nurses than anaesthetists or surgeons. Should behaviour be monitored in an invasive way in order better to prevent and sanction delinquent behaviour in terms of risk prevention ?.

Infection is costly for society and the hospital, and all the more so when the patient receives compensation. Hospitals will no longer be able to bear this cost if the chain of medical care malfunctions and aggravates the risk.

Setting up controls and conducting an assessment of the behaviour of all parties concerned are thus indispensible both in-house and among qualified suppliers. Hand cleansing, compliance with the length of use for protective clothing (bib, hat), targeted movement, bans on clothing or shoes worn outside the operating theatre, strict control of rest areas, limited access to the operating theatre during operations will guarantee the lowest possible risk for the patient.

 

 

The explanation for surgical site infections was found in several stages. The discovery of asepsis was the first step forward. Prevention then focussed on reducing direct contamination during the operation : protocols for skin preparation, the processing of air in operating theatres, single use fabrics, etc.

The second stage came with the introduction of prophylactic antibiotic treatment, which proved effective. However, for a number of years now, we seem to face an «infection rate that cannot be compressed ». Precautions are becoming ever more drastic, procedures increasingly complex, yet surgical site infections have not gone away, far from it. The idea that infections will be erradicated by yet again stepping up procedures designed to reduce possible contamination of the surgical site has reached its limit.

In practice, the idea of contamination responsible for the infection should be nuanced by the Altemeyer equation : an infection is a function of the play of strength between the germs and the patient who has undergone an operation :

 

 

I = importance of the inoculum x virulence of the germs

 

/Host resistance

The very principle of this equation highlighted the inevitable aspect of contamination and the fundamental role of host resistance. Prophylactic antibiotic treatment is proving its limits, even if it is an effective but indirect response to the concept of boosting host resistance.

We believe there are a number of mechanisms underpinning the onset of surgical site infections. Direct contamination is only one aspect, and there are many arguments in favour of a « hematogenic » mechanism occurring at the same time as the operation. How else can one explain the efficacy of prophylactic antibiotic treatment ? How can one explain infections caused by germs preferentially located in the oro-pharynx ? Kluytman's work has shown that patients become infected with their own germs. But what is the exact route followed by the germs ? Whatever the case may be,  the only commonality between all these different mechanisms is the way germs bind to material. We therefore believe that work on the prevention of infections should focus on bacterial adherence rather than a reduction of contamination, which leads nowhere. Several avenues are currently being explored, in particular a reduction in the inflammatory response by controlling surface states and covering material with anti-adherence substances.

 

 

The onset of surgical site infections (SSIs) is influenced by a number of factors, partially taken into account by the widely used CDC score (length of the operation, Altemeier classification, prior state of health assessed by the ASA score).

 According to this score, the incidence of SSIs after aseptic surgery is slightly under 1% for patients in level zero (none of the above risk factors). We do not really know whether these residual infections are linked to imperfections in the complex chain of prevention or to factors that have not yet been properly explored.

Recent work has shown the relationship between carrier prevalence, particularly nasal (MSSA and MRSA), and post-operative risk of infection with the same germ. Bacterial genetics have shown that 70 to 80% of SSIs are linked to the same germ as the one present in the nose before the operation. Extensive use is now being made of local antibiotic nasal decolonisation (Mupirocine) in cardiac and orthopaedic surgery departments even though the effectiveness of this method has not been fully proved. We do not really know how the patient's nasal germs reach the operating site. An airborne or handborne pathway is usually mentioned, but other possibilities remain (in particular, an intra-operative or immediate post-operative hematogenic pathway).

There is thus scope for improvement; what is lacking are the scientific data to back the various possibilities. There is an urgent need to work on the relationship between preoperative colonisation in various sites and post-operative infection, which could lead to « à la carte » prevention, the exact mechanisms of operating site contamination, the importance of the immediate post-operative period and the ideal timing for prophylactic antibiotic treatment, the rôle of post-operative immunodepression and the value of antibiotic coated prostheses. Thanks to this work and the preventive measures it will spawn, we can hope to divide SSI rates by 10 in the coming decades

Antibiotics are currently combined with implants only to treat infections, through the use of orthopaedic cements impregnated with gentamicine. Several new technologies, at different stages of development, are now emerging to reduce the risk of infection with medical implants :

 anti-microbial coatings based on silver powder; it has long been known that this metal combats bacterial proliferation in contact with the implant;

nanotechnologies, which can be used to functionalise implant surfaces by grafting anti-microbial molecules, or the creation of nano pores on the implant surface to house the active ingredients and gradually release them in the body ;

a combination of bio-resorbable polymers and antibiotics for sustained release of these active ingredients.

The regulatory procedures that apply to these products, viewed as drugs, act as a brake on their development. Similarly, issues pertaining to the type of drug to use and its possible loss of efficacy over time or the flexibility requested by surgeons in the drug mix they wish  to use have not yet been elucidated.

Yves-Alain, after studying mechanical engineering, has spent his entire career with Tornier, as plant director from 1982 to 1986, R&D director from 1986 to 2006 and Research director since 2006. In these various capacities, he has managed the design of Tornier products currently on the market 

Deep infection remains a great problem, yet all the mechanisms of infection are not clearly understood.

Cetain genetic polymorphisms have been shown to be associated with infection in other medical conditions. We have performed case control analysis and microarray expression profiling to further delineate possible associations with candidate genes.

Numerous genfes have been implicated in the biological reaction initiated by wear debris and bacterial infection that results in bone loss around total hip replacements (THR).

Individual responses to such stimuli may be dictated by genetic variation; we have studied the effect of single nucleotide polymorphisms (SNPs) within these genes.

Genetic polymorphism of the candidate genes identified may play a significant role in THR aseptic loosening and possibly in deep infection. SNP markers may serve as predictors of implant survival and response to therapy such as anti-TNF treatment.

 Immediatly after puting an implant (joint prosthesis, vascular prosthesis, catheter...) there is a race for the surface between host proteins enabling the tolerance of the implant and bacterial proteins at the origin of implant related infection. Treatment and modifications of implants surface is one of the axis of implant related infections prevention

 Antibiotics are currently combined with implants only to treat infections, through the use of orthopaedic cements impregnated with gentamicine. Several new technologies, at different stages of development, are now emerging to reduce the risk of infection with medical implants :

• anti-microbial coatings based on silver powder; it has long been known that this metal combats bacterial proliferation in contact with the implant;
• nanotechnologies, which can be used to functionalise implant surfaces by grafting anti-microbial molecules, or the creation of nano pores on the implant surface to house the active ingredients and gradually release them in the body ;
• la combination of bio-resorbable polymers and antibiotics for sustained release of these active ingredients.

The regulatory procedures that apply to these products, viewed as drugs, act as a brake on their development. Similarly, issues pertaining to the type of drug to use and its possible loss of efficacy over time or the flexibility requested by surgeons in the drug mix they wish  to use have not yet been elucidated.

Yves-Alain, after studying mechanical engineering, has spent his entire career with Tornier, as plant director from 1982 to 1986, R&D director from 1986 to 2006 and Research director since 2006. In these various capacities, he has managed the design of Tornier products currently on the market. 

Prosthesis infection is a recurrent problem; on average, 1.5% of joint prostheses become infected. As many strains of bacteria are resistant to antibiotic treatment, the problem has become even more acute. Solutions must therefore be found to prevent prosthesis and medical device infection.

To mitigate these problems, several research strategies have been proposed or are under study, and will be developed.

One example is the grafting of bioactive polymers capable of inhibiting bacterial adherence on various prosthetic surfaces. This approach constitutes a very promising solution to prevent infection. The modified surfaces exert a controlled form of action on  the biological environment. Protein adsorption and the bacterial and cell responses are controlled. These surfaces are integrated in the surrounding tissue and not just tolerated. There are also other solutions based on different mechanisms of action.

The main points of my talk will be:

• - Discussion on epidimiology of periprosthetic joint infection
• - Challenges of treating PJI (lack of effective local delivery mechanism)
• - Discussion of biofilm
• - Novel strategies for local delivery of antibiotics
• - Discussion of our organosilane chemistry allowing covalent bonding of antibiotics to surface
• - Presentation of some in vitro and in vivo results evaluating the novel technologies.

Javad Parvizi MD, FRCS is a Professor of Orthopaedic Surgery at Thomas Jefferson University with interest in pelvic, hip, and knee reconstruction with special emphasis on joint preservation. As the Vice Chair for Research, he oversees the operations of clinical and basic science research. He has extensive experience on conducting clinical trials and outcome studies on joint replacement patients. In addition he is actively involved in basic science research in tissue engineering and has received numerous grants from the National Institute of Health, Department of Defense, and other funding bodies for his work on development of self-protective smart orthopedic implants. He is a member of American Hip Society, Association of Hip and Knee Surgeons and has served in leadership roles in a large number of national committees. He serves as a member of study section for the National Institute of Health and various other funding organizations. He is a member of various editorial boards for orthopedic journals. He has received wide recognition for his clinical and basics science research. He is the author of over 200 peer reviewed papers, book chapters, and books 

 Hand cleansing is our leading concern both in daily care and in the operating theatre. Alcohol-based cleansing is back and is changing our habits, but we must still not forget the basic rules of surgical hand washing. Gloves are designed to protect the patient from the surgeon's skin, where germs may not be saprophytic for all concerned ! How should gloves be used, what are the hard facts and limits of surgical gloving ? What kinds of improvements will be on offer from manufacturers

 

In Progress

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New practice of the surgical hands cleansing. Efficiency of the hydro-alcoholic products.

 

Surgical gloves are intended to provide an effective mechanical barrier against potentially infectious material and other contaminants. However, glove perforation is common in surgical practice. Most of the glove perforations remain unnoticed by the wearer and are discovered only when gloves are removed. In theory, failure in the glove mechanical barrier allow microorganism diffusion from the surgeon to the patient, or reversely. Whereas the role of occupational exposures by contaminated instruments (i.e. parenteral exposure) for virus transmission and consecutive infection risks is unquestionable, the role of “passive” glove perforations for bacterial or/and viral infection prevention is less studied.

The barrier integrity is therefore the key issue in the protection. It mainly depends on the feature of the glove material (manufacturing process, quality controls, and glove thickness), the gloving practice (double gloving, frequency of glove change) and the surgical practice itself (speciality, duration of surgery).

This talk will propose an overview on “glove science” and gloving practices as the “ultimate barrier” against infectious materials transmission.

 

Is the surgeon in the operating theatre the pilot in the plane ? Not exactly, but an infection is still a crash for the patient, first and foremost, but also for the surgeon, the hospital and the care-giving team. Within the team, each member has a part to play in terms of organisation, planning, safety, discipline, and each member has to keep an eye on the rest of the team, not to remonstrate but to ensure everything is as perfect as possible, to watch out for the mistake anyone can make but which, together, we can avoid. Anthropologists can make a fundamental contribution to behavioural progress. Aviation, sociology and anthropology are three areas of human endeavour we shall rapidly review...

The average risk of a serious, undesirable event, like a surgical site infection, during a stay in hospital for surgery is 3 to 10%; 2 to 10% of these events are fatal; 35 to 50% are avoidable. The risk of a plane accident is 1 for 10 6 airport movements.

 In terms of hospital certification and the accreditation of high risk specialities, there is therefore every reason to analyse the factors that contribute to this level of safety and which differentiate the organisation of the two systems in order to define which measures can be applied to surgery, particularly in the operating theatre. Analogies in terms of flows, teams, interprofessional coordination and continuity of management justify this approach.

There are several potential avenues of work : improvement in the collective management of the operating theatre and hence its governance, strict rules to manage distractions (sterile cockpit), better communication between the various professions (briefings), better organisation of safeguards (check list), recovery and attenuation, shared respect for procedures, initial and lifelong training (periodic requalification of pilots).

Dr. Thierry Perniceni is a digestive surgion, Digestive Pathology Medico-Surgical Department, Institut Mutualiste Montsouris. Former Paris Hospital Intern. Associate University Professor, doctor qualified in cancerology, expert practitioner in accreditation, in charge of teaching « Risk prevention Management in Surgery in light of experience in civil aviation » at the European School of Surgery. Member of the Management Board of the Foundation for Training in Surgery, member of the scientific board of Medical Prevention.

Dr. René Amalberti, professor of Physiology and Ergonomics at Hôpital du Val de Grâce, spent 32 years with the military doctor corps as researcher and clinician specialised in risk management. Seconded on several occasions during his career, with senior national and international positions in the management of risks in medically related areas (air safety, road safety, industrial risks), he now apportions his time between the SouMédical – groupe MACSF, where he works mainly for Medical Prevention, and HAS, where he advises on safety of care in the accreditation and certification department.

 

It is a well-known fact that the operating theatre is a complex sociotechnical system; it is complex partly because the system is sequential. Moreover, while the events that occur are very serious, they are rare, which may spawn a false sense of security.

Risk in surgery comprises the risk linked to the disposition of the patient and the operation, but above all the risk linked to the functioning of the system and the general performance of the team and that of each team member.

The organisational and human factors clearly prevail. An organisation deemed safe simply on the strength of its design is misleading and probably dangerous. Safety features are indispensible :

• - precise planning of elective surgery based on written documents that are fully complied with
• - identity monitoring (secured access to operating rooms, reception  procedure, repeated controls, cross-checks...)
• - ultimate « time out »

In terms of human resources, setting up surgical teams comprising qualified, competent, healthy people who know how to communicate, adapt and work as a team is indispensible !

The human capital must be respected while at the same time developing an organisational culture based on the collective, shared perception of risks.

 

 

While prevention seems to be the best means of combatting nosocomial infections, in everyday life the anthropologist can observe a reluctance to obey instructions, which cannot necessarily be explained by a lack of information. Over and above any bacteriological or disciplinary reasons, what is at stake is the individual commitment of each of the players and the organisation and functioning of the teams, the cultures and socio-professional identities. 

Surgical infection may be linked to intraoperative contamination. Controlling environmental biological contamination is thus of paramount importance to combat this phenomenon. Air, water or surface quality – whatever the case, piercing the secrets of bio-contamination means penetrating the world of the infinitely small, a mysterious, little known area which is often ill appreciated by care-giving teams. Controlling the microbiological risk is thus a major challenge that begins with the designing of the operating theatre. Running and maintaining the operating theatre must also comply with compulsory regulations in terms of hygiene, safety and quality. These constraints sometimes conflict with the organisational and economic requirements of real life.

 

General architecture and structure

• - The general layout of the operating theatre provides for sectors, flows, practices; organised around the recovery room, it strikes a balance between space and time, a function that must be organised.
• - How can large operating theatres retain a human dimension ?

Filter premises :

• - They are of paramount importance in the control of incoming and outgoing flows : from the changing rooms, patient access, etc., to sterilisation
• - How should they be organised ?

The operating theatre and ambulatory care :

• - Time spent in the operating theatre is diminishing; ambulatory care makes it necessary to rethink circuits in light of patient flows.
• - How can asepsis be maintained with short flows ?
• - Challenge that begins with the designing of the operating theatre. Running and maintaining the operating theatre must also comply with compulsory regulations in terms of hygiene, safety and quality. These constraints sometimes conflict with the organisational and economic requirements of real life. 

In Progress

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• - The risk of contamination from the environment in a hospital setting; premises subject to reinforced hygiene
• - Clean rooms, standards, principles
• - clean room envelope (partitions, ceilings, doors, accessories) :

                   - Choice of materials

                   - Interfaces, junctions, connections

                   - the integration of fluids or equipment

                   - maintenantce and cleaning

• - The operating theatre : special features, recommendations

 

Consensus has been reached, at least in theory, on any number of  recommendations on biocleaning, in particular in the operating theatre. Implementation, however,  runs up against many difficulties :

• - the organisation required (outsourcing of this function or not),
• - the choice of materials and products to use (efficacy, ergonomics, direct and induced costs, training and protection of professionals using them, etc)
• - evaluation of the quality of biocleaning (why, how, by whom, according to which method, to what end),
• - the advent of new requirements, in particular environmental friendliness and the commitment of hospitals to sustainable development.

There are thus numerous contraints, the economic dimension being one of the most important, and a single answer is not possible; it is up to each establishment to find the best solution in light of its needs and constraints.

The part played by air contamination in the onset of a surgical site infection is now irrefutable. According to AFNOR standard NF S90-351, which dates from June 2003, class 1 orthopaedic surgery (clean surgery with implanting of material) requires an ISO 5 particulate and bacteriological quality of air that can only be provided by unidirectional (formerly called laminar) and multidirectional (formerly called turbulent) flows. However, only  unidirectional flows can maintain this air quality in an active operating theatre. To re-establish an ISO 5 quality of air before a new operation in a room equiped with a multidirectional flow, it is necessary to wait for a given period of time, with no one in the room, so the air can be cleaned and suspended particles removed. It is up to each establishment to determine the time required and it is up to all the users to respect this time.

 

 The part played by air contamination in the onset of a surgical site infection is now irrefutable. According to AFNOR standard NF S90-351, which dates from June 2003, class 1 orthopaedic surgery (clean surgery with implanting of material) requires an ISO 5 particulate and bacteriological quality of air that can only be provided by unidirectional (formerly called laminar) and multidirectional (formerly called turbulent) flows. However, only  unidirectional flows can maintain this air quality in an active operating theatre. To re-establish an ISO 5 quality of air before a new operation in a room equiped with a multidirectional flow, it is necessary to wait for a given period of time, with no one in the room, so the air can be cleaned and suspended particles removed. It is up to each establishment to determine the time required and it is up to all the users to respect this time.

Surgical instruments were customarlly sterilised in the place where they were used. Outsourcing consists in having it done by industrial structures located some distance away. As a result, there are constraints in terms of transport, availability, management.  Several years later, users and service providers report on their experience.

In Progress

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In Progress

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• - Introduction : the context
• - The expectations of the pharmacy and the operating theatre
• - Problems encountered and action taken
• - Prospects

 

The sterilisation of surgical instruments is a complex process that must be fully mastered. Identifying risks in sterilisation calls for full understanding of the production cycle and the product life cycles. Computerised traceability is a means of controlling sterilisation risks.

Tracing operations or the sterilisation process (unit traced = packaging) is done using dedicated sterilisation software that has been available for some 10 years. Computerised tracing of surgical instruments (unit traced = surgical instrument) is not a routine practice at present; several hospital trials are underway to validate the best method of identifying surgical instruments using two emerging technologies (data matrix code and RFID chips). The goal of this work is to provide feedback on surgical instrument traceability and sterilisation in Bichat – Claude Bernard hospital.

As of 2008, RFID chips have been placed on 360 instruments ( RFID transponders housed in a resin, encapsulated in a stainless steel case welded to the instruments) used for three cardio-pulmonary bypass units in the cardiology operating theatre. The Sédisté traceability software and a wireless reader make it possible to trace these  instruments and replace them in the CPB boxes after use. The functional analysis and feedback show that this traceability system is reliable, robust and comprehensive. The chips withstand sterilisation (cleaning and autoclaving at 135° for 20 minutes) and do not interfere during surgery. After this first experimental phase, the decision was taken in 2008 to extend RFID traceability to the 7000 instruments in the cardiology operating theatre to assess any dangerous situations and the scenarios leading to a feared event that can be avoided by this traceability system, and in daily practice to asses the constraints encountered on a large scale. How can the instruments be sent away to be equipped with a chip by a supplier without upsetting surgical activity (unavailability, transport, management of non-compliant practices) ? How can these instruments be traced on a routine basis (personnel training, management of instrument mix-ups and losses, parametering and user-friendliness of the software, monitoring of maintenance, ...? Can one trace all the instruments and at what cost ? 

Traceability using RFID technology is a novelty in hospital sterilisation and makes it  possible to meet user needs and comply with rules and regulations. Routine use of instrument traceability using RFID will make it possible to assess the added value of this technology on a significant scale – in particular, bettter management of the stock of instruments (purchase, maintenance), use of personnel less qualified in packaging by reducing non compliance in this critical stage, which may have a major impact on conditions during surgical operations. 

 

Femoral prosthesis instruments are usually made of metal components that are re-used after cleaning and sterilisation by the hospital. The idea was to replace them with single-use instruments made entirely of plastic components. These instruments have several advantages : reduced risk of infection, lower handling costs, flexibility in the operating theatre, etc.

Presentation on the use of this new type of instrument in total hip replacement; benefits for the surgeon, the patient and the hospital. 

The microbiological diagnosis of surgical infections entails the use of culture and identification techniques in addition to tests to determine sensitivity to antibiotics.The principles were defined several decades ago. The key industrial players in diagnostics have tried to automate these traditional processes, but the incorporation of methodologies borrowed from biotechnologies in daily diagnostic practices is still to come. These « ics » sciences – biomecanics, genomics, proteomics – that have revolutionised the diagnosis and treatment of viral infections have now achieved the degree of maturity required to envisage their introduction on a large scale in the bacteriology laboratory. We shall review the expected benefits of the imminent introduction of these tools in the management of patients suffering from surgical site infections.

 

The crucial step in patients with implant-associated problems is the accurate diagnosis of infection. Current microbiologic tests include culture of joint aspirate or intraoperative periprosthetic tissue. These specimens have often insufficient sensitivity or specificity, particularly for low-grade infections. Therefore, novel approaches for accurate diagnosis of implant-associated infections were developed. Sonication of the removed prosthesis improved the detection of infection by dislodging adherent (biofilm) bacteria from the surface of the implant. In a prospective trial including 331 patients with total knee or hip prostheses, the sensitivity of periprosthetic-tissue was 61% and for sonication cultures was 79% (P<0.001). Sonication can improve the diagnosis of prosthetic joint infection (or exclusion thereof) and should be performed whenever the implant is removed.

Infections are one of the main complications linked to the use of joint prostheses. The diagnosis of the infection is based on a series of reasons, which in some cases do not lead to a sure diagnosis as the conventional means of detecting the infection may prove insufficient. Ingen Biosciences has thus invested in the search for protein markers for Staphilococcus aureus and Staphylococcus epidermis (species of bacteria involved in 50 to 75% of joint prosthesis infections) and the development of a quick, non invasive serodiagnostic test : BJIInoPlexTM. The test meets several aims :

• - Help to diagnose an infected prosthesis as opposed to aseptic loosening.
• - Monitor the course of an infection treated with antibiotics
• - Offer a serological monitoring of patients with prostheses to diagnose infection earlier on and begin treatment when the infection is just starting.

Bacterial identification in clinical microbiology is currently based on the use of mainly phenotypical biochemical test panels, which have several major shortcomings :

• - They are costly
• - They are slow;
• - They are inaccurate and can cause mistakes in identification particularly in the case of unusual pathogens and numerous species of emerging pathogens, found in particular in joint infections.

Additional tests to confirm findings are thus required, in particular the sequencing of specific genes (RNAr16S, rpoB, sodA, ...). This is viewed as the stock method but it is outsourced and takes time.

 The MALDI-TOF technique coupled with mass spectrometry has recently been proposed to identify bacteria.

Mass spectrometry can produce a specific « bar code » for each species of bacteria; they can thus be identified almost as accurately as with stock techniques. Pathogens that have not yet been described can also be recognised.

This technique is particularly effective in the identification of isolated species causing joint infections and therefore has major advantages compared with conventional techniques :

• - Accuracy comparable to stock  techniques
• - Low cost of consumables
• - Quick results (one minute per strain).

The Ile de France region and the hospitals involved in the management of joint infections are developing a network of laboratories equipped with this tool in order to assess the value of this technology on a large scale in the management of patients with severe joint infections.

Cepheid's core business is rapid molecular diagnostics based on real-time PCR. It develops, makes and offers modular systems and a wide range of tests. These systems are easy to use and provide for rapid detection (between 1 and 2 hours) of infections linked to medical care (MRSA, VRE, Clostridium difficile) and other infectious diseases (tuberculosis and rifampicine resistance, group B streptococci, enterovirus)

 

Since the advent of prophylactic antibiotic treatment, no other procedure to prevent surgical site infections has been scientifically validated. Current surgical site infection rates are so low that statistical studies have reached their limits. Yet progress is still needed to work towards a « zero infection » goal. Research underway seeks to reduce intraoperative microbial colonisation in the hope of reducing the rate of infection. To avoid being trapped by the precautionary principle, one must take a critical view of these new procedures while at the same time enthusiastically welcoming them.

 

• - Epidemiology of surgical site infections and the use of surveillance data ;
• - Evidence based infection control measures (antibiotic prophylaxis, preoperative screening and decolonization, razor, role of hypothermia and hypoxia, impregnated sutures, influence of the OR ventilation system, skin disinfection) ;
• - Implementation of infection control measures and general quality management.

 

 

• - S. aureus is the major cause of surgical site infections
• - MRSA is endemic all over the world and adds to the total burden of disease
• - Many patients are infected with their own S. aureus strain
• - Preoperative screening for S. aureus carriage and treatment of carriers reduces post-surgical the infection rate with 60%

 

The surgical treatment of infected total hip prostheses in one or two stages is a controversial topic. We shall endeavour to take stock of the situation. The current trend seems to be to choose one or two stages depending on several pre-operative criteria (bacteriology, clinical record, predisposition); the national and international teams that regularly treat these patients must work together to define decision-making trees that will make it possible to choose the best strategy in each case.

 

The rate of infection after total hip arthroplasty has decreased over the last three decades.  Current rates are estimated to average between 1 to 2% for primary total hip arthroplasty. 

Despite an improvement in its management, it remains a significant difficult problem to manage.  The goals of treatment are to: 1) eradicate infection, 2) alleviate pain, and 3) restore function of the affected limb. 

Treatment options include: 1) antibiotic suppression, 2) debridement with retention of components, 3) resection arthroplasty with no reimplantation, 4) hip disarticulation, and 5) removal of prosthesis with subsequent reimplantation. 

Reimplantation offers the best chance for optimal functional outcome.  The two-stage approach in North America is currently the treatment of choice for the chronically infected total hip arthroplasty, although a one-stage approach is occasionally a better option. 

The advantages of the two-stage include a second-look/second-debridement before reimplantation.  Reimplantation does not need to be an all-cement reimplantation as the advocates of direct exchange recommend, and a higher reported success rate.

The disadvantage of a two-stage include the time interval between the first and the second stage, the pain and limitation of function in between the stages, and the stiffness encountered at the time of reimplantation and the possibility of soft tissue contractures which may occur during the time interval. 

What is still controversial, however, it the optimal duration between stages, the optimal duration of route of antibiotic delivery, the efficacy of antibiotic spacers and bone cement, the role of spacer blocks or a Prostalac on the functional outcome, and the optimal fixation at the time of reimplantation.

Indications for reimplantation include good bone stock, adequate soft tissue envelope, and an immunocompetent patient and sensitive organism.  Contraindications for reimplantation include persistent infection and an immunocompromised host, extremely poor bone stock, and extremely poor soft tissues. 

For the two-stage approach, the first stage includes removal of sinus tracts, prosthesis, removal of all cement, and an extensive soft tissue and bony debridement, obtaining cultures, and placement of antibiotic cement spacer.  Whether to use an articulating versus a statis spacer is a matter of choice.  The placement of a spacer has the advantages of local delivery of antibiotics as well as the maintenance of soft tissue length.  Its disadvantages include the fact that it is a foreign body and that bone loss may occur around the spacer.  The typical dose for the spacer includes 3 to 4 grams of vancomycin and 3.6 to 4.8 grams of tobramycin per batch of cement. 

The second stage of reimplantation should be done once eradication of infection has been documented clinically by either normal or near-normal infection labs and by frozen section and gross inspection of the joint at the time of surgery.  Uncemented implants are our preference.  If cement is going to be used it should be loaded with antibiotics. 

Using this treatment algorithm, one should expect greater than 85-90% success rate in eradication of infection in the majority of patients. 

 

 

Joint prosthesis infections are growing in importance in European orthopaedics. Although the infection rate for hip prostheses is only 1.5% and knee protheses around 2.5%, actual numbers show that this is becoming a major economic issue. The treatment of these prostheses must therefore be standardised and made as adequate as possible. There are two school of thought at present. The predominantly German-speaking school advocates one-stage reimplantation versus the more Anglo-Saxon school which proposes two-stage reimplantation.

Each school has advantages and disadvantages, but it seems extremely important to focus discussion not just on one or two-stage reimplantations but also on the patient. By following the therapeutic guidelines published by the Zimmerli-Trampuz and Ochsner group in the New England Medical Journal in 2004, one can easily distinguish several groups of patients who will benefit from highly individualised management. These guidelines make it possible to choose, depending on the duration of the infection and the local status, between keeping the prosthesis after debridement and an extensive redo. This is possible in early post-operative and early hematogenic infections (under 3 weeks). A single-stage change of prosthesis is possible in patients with good quality soft tissue without major abcess formation, with germs sensitive to dual rimactan therapy, which provides for post-operative antibiotic treatment to protect the new prosthesis. Two-stage surgery is more suitable for patients with poor soft tissue, like a fistula for example, with difficult to treat germs; in this kind of situation, preference should be given to a two-stage approach in order to choose between a short and a long gap and a module with or without a spacer depending on the germs.

This presentation seeks to illustrate the concept developed by the Liestal group as applied and somewhat adapted by the Lausanne group.

In Progress

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A skin incision is the first, necessary stage in surgery. We thus open the patient's external barrier to bacteria, including the patient's own bacteria. How can the skin remain decontaminated throughout the entire operation ? Are all antimicrobials equally effective in preparing the skin and how can their action be made to last intraoperatively ? How can one protect against the skin while respecting and protecting it ?

Patients undergoing elective surgery risk infection with a number of bacterial pathogens some of which are acquired endogenously and others exogenously. In addition several of these pathogens have developed multiple resistance to antibiotics used in treatment of infection. In particular the risk of infection with meticillin-resistant Staphylococcus aureus (MRSA) and Gram-negative bacilli carrying extended spectrum Beta lactamase enzymes (ESBL’s) has increased in recent years necessitating increased attention being paid to infection prevention strategies. Following the ‘search and destroy’ tradition set by The Netherlands and the Scandinavian countries in which all patients entering hospital are screened for MRSA and if found to be positive carriers of this organism, are decontaminated using antiseptic washes and topical antibiotic. Various combinations of antiseptics and antibiotics have been used with varying success. However resistance/tolerance to some has been demonstrated suggesting that some changes are needed in our choice of antimicrobial agents. Older (chlorhexidine, povidone iodine and triclosan) and newer (octenidine dichloride) antiseptics will be compared for activity against MRSA and other hospital pathogens in vitro and in hospital based in-use studies. Their efficacy in relation to reduction of risk of post-operative infection will be assessed.

Emeritus Professor of Bacterial Infection and Epidemiology, University of Glasgow and Professor of Microbial Infection, University of St Andrews, previously Director of the Scottish MRSA Reference Laboratory, Fellow of the Royal College of Pathologists, author of more that 220 peer-reviewed publications.

 

 We have been using InteguSeal to prepare the skin for traumatological orthopaedic surgery for approximately four years. Arthroplasties are increasingly performed using small incisions in the skin. Retractors, surgical instruments and even parts of the prosthesis may be in regular contact with the skin from beginning to end of the operation. We also use so-called minimally invasive or percutaneous techniques and InteguSeal, a microbial sealant, is indispensible as it provides extended protection of the edges of the wound. We have noted that Integuseal is far more suitable for skin preparation than adhesive surgical drapes (the film-type that is incised), which do not adhere for long during the operation owing to bleeding and regular lavage. Furthermore, InteguSeal only takes a few minutes to dry, the time required to organise the various systems of coagulation. The operation can then begin.

 InteguSEAL* Microbial Sealant is a new, non-pharmaceutical solution to reducing the risk of skin flora contamination throughout a surgical procedure.  This product was developed in order to prevent the migration of bacteria that survives the prepping process into the surgical wound.  A significant amount of in vitro and in vivo testing has been completed to demonstrate the efficacy of this product.  This presentation will review the highlights of this testing.

As the prevention of SSIs (surgical site infections) is a priority for all those involved in the hospital setting, ETHICON has developed and marketed the first antibacterial sutures - VICRYL* Plus & MONOCRYL* Plus - and has just launched PDS*Plus Antibactérien (January 2010).

• - How important is the choice of sutures in orthopaedic surgery today ?
• - What is the point of antibacterial sutures in this special field ?
• - What level of clinical proof currently bears out the efficacy of these new medical devices ?
• - Discussion of the latest clinical and medico-economic studies published.

 

DERMABOND is a skin adhesive that creates an antibacterial occlusive bandage. Its anti-bacterial properties protect against the bacteria mainly responsible for SSIs. This paper will describe these properties, recognised by the FDA, backed by a number of studies that have been published.

Skin and soft tissue infections following to surgery are unfortunately common and range from minor pyodermas to severe necrotizing infections. Classification schemes for these infections are varied and confusing. Distinguishing characteristics include the etiological agent(s), clinical context and findings, depth of tissue involvement and rate of progression. Surgical debridement remains important for many complicated infections especially for necrotizing infections. The different pathogenetic ways from skin to infection are presented and treatment regimens are critically discussed. Furthermore the influence of triclosan -coated suture material on preventing surgical site infections will be evaluated. 

 

 

The choice of incision

The quality of closure

Surveillance

 

 

 The treatment of bone infections is complex owing to the characteristics of bone tissue and the foreign materials in contact with the bone. This is also true in other surgical specialties that work with bone or inert materials. Are the infection rates and germs responsible the same ? What are the difficulties and treatment strategies developed in these specialties?

 

 

• - Circumstances conducive to onset
• - Clinical and radiological diagnosis; treatments
• - periimplantite / Bacterial complications : peri-implantitis

 

There are differing assessments of the prevalence of vascular protheses infections. They are a frequent cause of death from hemorrhage, shock or septic metastases, ischemia and major amputation. Prevention strategies focus on the design of bacterial contamination resistant grafts. Treatment, largely based on removal and extra-anatomical arterial reconstruction, has been transformed by the use of arterial allografts.

 Infection is a complication that also occurs in veterinary surgery. Many of the characteristics are the same as in human surgical infection. The average rate of infection is 5.5%. Most infectious complications in orthopaedic surgery are bacterial, due to staphylococcus sp in 60% of the cases. Antiobiotics are used to prevent and treat veterinary infections. Their use should be reasonable to limit the risks of antibiotic resistance. Preparation of the patient and surgeon, respect for the rules of atraumatic surgery and post-operative care are of paramount importance in the prevention of infections in veterinary surgery.

 Mediastinitis in cardiac surgery is a serious complication; the incidence is between 1 and 3%.  It is more common in certain types of surgery (coronary artery surgery involving use of the mammary arteries) and in patients with certain predispositions (insulin-dependent diabetes). Prevention is based on conventional hygiene and has been strengthened by better understanding of the requirements of diabetic patient management. Diagnosis occurs earlier thanks to the use of systematic trans-sternal puncture if infection is suspected. Treatment has been improved through more effective management, which may differ depending on the types and predisposition. Mortality due to this major complication has been considerably reduced through management in specialised wards.

 

 The risk of nosocomial infection is a major concern in neurosurgery as neurological, functional or painful sequelae may result. All the French neurosurgical teams (in state or private practice) follow the recommendations issued by learned societies in terms of antibiotic prophylaxis and patient skin preparation protocols recommended by hospital hygiene departments.

The risk of infection depends on the type of surgery (skull, spine – use of implants) and whether it is elective or emergency. It has been defined with the help of hospital hygiene services and the CLIN. One of the indicators is the surgical site infection rate. Three types of surgery have been singled out in particular for neurosurgery (craniotomy for tumour removal or non-traumatic lesion, external ventricular drains, lombar discal hernia without lamninectomy or arthrodesis). These data are transmitted on a national level by the RAISIN (Nosocomial Infection Warning and Surveillance Investigation Network)  and are known, and updated every year, for each individual establishment. The latest known evaluations are : lombar discal hernia surgery (national teaching hospital nosocomial infection rate : 1.2%) and cranial surgery (national post-craniotomy nosocomial infection rate : 2.1%). Changes in behaviour (surgical technique, post-operative care protocol) have also made it possible significantly to improve the nosocomial infection rate for external ventricular drains. Other published indicators will be described in addition to a number of poorly known, but potentially risky situations like the combination of synthetic fabric (dura mater patch) and biological glue.

 

 Redress for a medical accident is designed to restore the past status of the  plaintiff by means of financial compensation. There are any number of procedures at present, ranging from mere conciliation to more complex legal procedures. The practitioner, judged in his or her medical practice, and the patient, the victim of the medical system, require assistance to organize their defense.

In an event, a medical-legal expert report will be drawn up. It will translate the medical events into legal language and describe the damage linked to the infection, the fact it can be put down to the care given, the possible shortcomings of the medical teams in terms of the prevention, diagnosis or treatment of the infection.

In the event the care-giving establishment or the practitioner are liable, the patient will be offered compensation. The care-giving establishment will also provide compensation in cases of nosocomial infections. If no fault is found, and only for the most serious cases, compensation for a therapeutic contingency or nosocomial infection will be paid out of a national solidarity scheme. The cost of these joint infections is huge : for the patient, who has suffered physically, psychologically and socially, for the medical system managing the infection, and also for the medical insurers or national solidarity scheme that sometimes provide compensation. Awareness in itself is a form of prevention.

In 2007, French nosocomial infection definitions were revised but did not contain criteria evaluating the attributable and preventable part of these infections.  The attributable part of HAI related to healthcare is evaluated according to French criteria developed by Muller et Cordonnier: reality of the traumatism, intensity of the traumatism (in connection with the damage), absence of anteriority (preliminary integrity of the injured area), concordance of the site of injury and traumatism, compatible time between the initial event and the disorders, evolutionary continuity or clinical sequence and certainty of the current diagnosis. Avoidability is defined as the identification, the enumeration and the description of the adverse effects being able to be prevented and seek to propose preventive actions to decrease the risks. It is reasonable to think that a HAI would be described as avoidable if it did not occur within the framework of a behaviour compatible with the most common recommendations. The results of HAI surveillance and interventional studies (bundle with formation) demonstrated that a significant risk reduction could be achieved, particularly for surgical-site infections.

The analysis of attributable part and avoidability needs to evaluate notably intrinsic (linked to patient) and extrinsic (cares for patient) risk factors of SSI. Additionally, uncertainties exist about the patho-physiology and the routes of infection (eg. carriage of S. aureus and risk of SSI development)

 

 

• - The means of defence for each party
• - The importance of medical records, traceability and quality of patient management
• - Writ of summons

• Criteria governing admissibility
• Rules governing compensation : fault, contingency, nosocomial infection
• Report on CRCI activity since 2002

The management of infected total hip protheses involves long and costly treatment. The aim of the study was to determine the costs of infected THR redos and to compare them with the costs of primary THR and non-infected THR redos. The various types of expenditure involved in patient management were identified; They include the pre-operative work-up, medical and surgical management during hospitalisation, the stay in a follow-up care and rehabilitation unit, post-hospitalisation antibiotic treatment in the case of septic redos and the cost of home hospitalisation where applicable. The cost of aseptic THR redos was 1.4 times higher than that of primary THRs. The cost was 3.3 times higher in the case of septic redos.

The economic impact of THR infection is huge. The additional cost is basically due to longer hospitalisation and rehabilitation involving considerable human ressources, infrastructure and equipment.

 

• - Trends in the number of cases
• - Headings under which compensation is granted
• - The average cost of compensation for infections
• - Status of the current system of compensation : Equitable ? Reliable ? Viable

• - What the patients go through : from infection to medico-legal procedures
• - The human consequences

Born 30^th March 1962. University studies in economic sciences. Creator and President of Lien (1998). spokesman for CISS (Collectif Inter Associatif Sur la Santé( (1999). Board member of the  « Observatoire National d’Ethique Clinique » (2002). Board member of the « Office National d’Indemnisation de Accidents Médicaux , des Infections Nosocomiales et des Affections  Iatrogènes » : ONIAM (2002). Mission of JF MATTEI, Minister of Health, on the structuring of health associations and criteria for approving health associations (2003-2004). Users representative within the  CTINILS : « Comité Technique National des Infections Nosocomiales et des Infections liées aux soins ». Expert reporting for the Ministery of health (2004) – Board member of the CNAMTS « Caisse Nationale d’Assurance Maladie » representing health system users (2004) - President of MIDISS « Mission de Médiation d’Information pour la sécurité des soins auprès de la Haute Autorité de Santé »  (2004) – Health adviser to the Mediator of the Republic : creation of the « Pôle santé et Sécurité des Soins du Médiateur de la République » (2009)