Institutions involved

Department XIV Clinic for Trauma Surgery and Orthopaedics, Septic Reconstructive Surgery

Research and Treatment Centre for the Reconstruction of Defect Wounds

 

We offer our patients – civilian as well as military – the entire range of examinations and treatments in the field of trauma surgery and orthopaedics using the most modern methods. We always orient ourselves to the individual requirements and needs of the individual patient. We have specialised in the areas of joint replacement (endoprosthetics) with alternating operations, sports and age traumatology, knee joint, shoulder and forefoot surgery as well as the treatment of complex infections of bones, soft tissues, joints and endoprostheses/osteosynthesis material and the coverage of soft tissues defects (septal reconstructive surgery).

 

In cooperation with the departments of vascular surgery and dermatology, we also offer a high level of expertise for the treatment of complex wounds and wound healing disorders at the certified Wound Center (IWC).

 

In addition to outpatient and operative treatment by the professional associations (including the Injury Type Procedure (VAV)), the clinic is certified as a Regional Trauma Centre (DGU) and is part of the Trauma Network Berlin.

 

As the academic hospital of Berlin University (Charité-Universitätsmedizin), we are very committed to research and teaching. We teach students of human medicine in clinical everyday life and participate in the training of young academics with lectures. Our scientific and international interest is particularly focused on wound and bone healing, infection treatment and prevention, regenerative medicine, compartment syndrome as well as emergency and disaster medicine and further training for surgeons.

 

The Section for Septic and Reconstructive Surgery at the Trauma Surgery Clinic has an experienced and well-rehearsed team of doctors and nurses who have been dealing with the rehabilitation of bone and soft tissue inflammations and the associated recovery measures as well as rehabilitation for years. Colleagues from trauma surgery, vascular surgery and plastic surgery are involved). Through very close cooperation with the hospital’s own microbiology department, its own specialist for hospital hygiene, its own hygiene officer in the department and hygiene nurses, an exceptionally modern hospital hygiene concept can be realised. This can maximally reduce the risk of so-called nosocomial infections, i.e. infections acquired in hospital. Through standardised rapid diagnostics, a highly differentiated use of antibiotics (Antibiotic Stewardship Program), outstanding experience in the field of septic surgery after severe wounds and injuries and an extraordinarily consistently trained nursing staff, we meet the challenge of surgical infections even with multi-resistant pathogens. In order to master these in the future, we will also use anti-bacterial bacteriophages (viruses that exclusively attack and kill specific bacteria).

Department XXIV Pharmacy of the Bundeswehr Hospital Berlin

 

The Department XXIV Pharmacy of the Bundeswehr Hospital Berlin is a central service provider. For our outpatients and inpatients, we supply all specialist departments and outpatient departments of the hospital with medicines and medical supplies. In addition, our staff is not only available on weekdays, but is also available for acute care in urgent cases at night and on weekends.

Here in our capital, our customers also include the highest federal authorities as well as the medical service of the Federal Foreign Office and the foreign offices of the Armed Forces Office.

 

In comparison to many hospital pharmacies, our mandate is broad. In addition to medicines, medical products such as dressings, sutures, orthopedic aids, dental consumables and diagnostics are also part of our medical supplies. The products are selected and procured under both qualitative and pharma-economic aspects.

In addition, we support the specialist departments of our company with the manufacture of special – non-commercially available – (emergency) drugs and medical products on a prescription and defect scale. Their manufacture is geared to medical requirements. Here, too, contemporary scientific as well as economic findings are incorporated into our work.

 

A broad field of activity of our pharmacy includes the performance of tasks relating to drug therapy safety. In addition to advising physicians and nurses in the wards on general pharmaceutical issues, we are also a leader in the field of drug information and therapeutic drug monitoring. The determination of blood levels of therapy-relevant antibiotics, as well as the accompaniment of rounds and cooperation in various project groups and commissions of the company, e.g. antibiotic stewardship. In order to achieve and maintain this goal, we attach great importance to the professional qualification and further training of our pharmaceutical staff. In order to secure the next generation of pharmacists, we are intensively involved in the training of all pharmaceutical professions – from pharmaceutical commercial employees to pharmaceutical technical assistants and pharmacists.

 

As our civilian employees and soldiers of the Bundeswehr Hospital pharmacy have formulated in their self-developed mission statement, we see ourselves primarily as a customer-oriented service provider.

Department XXI Clinical Microbiology and Hospital Hygiene

 

The Department XXI Clinical Microbiology and Hospital Hygieneof the Bundeswehr Hospital (BwK) Berlin combines diagnostic and preventive medical elements of infection medicine. In the laboratory unit of bacteriology, mycology and parasitology, microscopic, cultural, biochemical, immunological and mass spectrometric methods are used to detect and differentiate microorganisms from clinical samples, with particular emphasis on the recognition of characteristics of drug resistance. Conventional diagnostics are supplemented by molecular biological methods for which a special laboratory segment is available. The diagnostic spectrum is rounded off by infection serology, in which infectious agents and immunity phenomena are detected by immunological tests. The entire laboratory diagnostics are embedded in a quality management system according to DIN EN ISO 15189. Hospital hygiene benefits from “short distances”, as it is responsible for monitoring the occurrence of infections at the hospital and coordinating all measures to prevent the spread of pathogens in the hospital environment.

 

For more than 5 years, microbiology at BwK Berlin has been committed to the strict implementation of the principle of “Antibiotic Stewardship” (ABS), i.e. the intelligent and interdisciplinary use of antibiotics in the treatment of infections. Especially against the background of the increasing spread of multidrug-resistant microorganisms, the combination of microbiological expertise, clinical treatment competence, pharmaceutical know-how and hygienic skills is more important than ever. Since many patients suffering from chronic wound infections with problematic pathogens are treated at BwK Berlin, the consistent application of the ABS strategy is an important instrument both for therapy optimization and for influencing the increasingly unfavourable resistance situation. Nevertheless, this approach can also fail if infections whose pathogens can no longer be controlled by antibiotics are to be treated.

 

Here other principles can be considered, e.g. the use of bacteriophage preparations. In the PhagoFlow project it is the task of microbiology to detect and characterize the relevant pathogens and to describe the antibiotic treatment options. If bacteriophages are to be used, suitable phages from the existing stock in the hospital pharmacy must be identified with regard to their efficacy. This is done by using the phage susceptibility test, the phagogram, which is carried out in the microbiological department of the BwK Berlin after the methodology developed by the consortium partner DSMZ has been established and optimized in cooperation with the Braunschweig colleagues.

 

The phagogram team is led by the clinical pathologist Martin Müller and the two microbiologists Birgitt Lang and Renate Gatzer. The clinical pathologists Werner Wenzel and Markus Nußbaum, supported by the assistant physician Robert Ahrens, are available as system specialists for the processing of the equipment. The technical laboratory work is the task of the laboratory assistants Marina Blaschke and Morten Leddin.

Department Bioresources for Bioeconomy and Health of the Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH

 

In 2019, the ISO 9001-certified Leibniz Institute DSMZ celebrates its 50th anniversary since its foundation as a university microbe bank of the University of Göttingen. Today, the DSMZ is one of the world’s largest and most diverse bioresource centres and has five departments. The Bioresources for Bioeconomy and Health Department also houses the growing phage bank with the task of providing the bioresources for research, industry and teaching. Phages are deposited by research groups, but increasingly isolated and characterized from natural habitats by the phages research group itself. The phages are then added to the public collection or to the group’s own application-oriented projects. The DSMZ infrastructure allows all modern methodological approaches to the research of any phages, including genome sequencing and bioinformatics. For the PhagoFlow project, DSMZ is compiling efficient phage sets for prioritized frequent bacterial pathogens, which will be purified at Fraunhofer ITEM and later administered to individual patients in individually adapted mixtures (phage “cocktails”). Each of these phages was previously tested in the DSMZ for efficiency and safety criteria and its biological properties.

Pharmaceutical Biotechnology Division of the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)

 

The ITEM is a Fraunhofer Institute with three locations in Hanover, Braunschweig and Regensburg, which are involved in contract research relating to human health. The “Pharmaceutical Biotechnology” division in Braunschweig focuses on the development of biopharmaceutical drug production processes and the subsequent GMP production of active substances and clinical test samples. Pharmaceutical biotechnology has been GMP-certified nationally and EU-wide since 1997. The spectrum of active substances processed to date ranges from recombinant proteins, glycoproteins / antibodies to nucleic acids, bacteriophages and viruses.

 

In the PhagoFlow project, pharmaceutical biotechnology will first develop a largely generic manufacturing platform for phage active ingredients for use in magistral preparations. Subsequently, phage isolates provided by the PhagoFlow partner DSMZ will be successively multiplied and made available in pharmaceutical quality to the hospital pharmacies of the PhagoFlow project consortium for the production of magistral preparations.

 

This platform comprises standardised cultivation and purification steps and is intended to make it possible to transfer an established manufacturing process for phage as active pharmaceutical ingredients from one phage to another by fine-tuning parameters. After receiving the phages and their respective production strain from the DSMZ, the Fraunhofer ITEM will first establish manufacturing processes on a laboratory scale. After the production strains have been cultivated, they are infected with phages, which leads to their multiplication up to the complete lysis of the production strain. The purification of the phages is optimized by up to 2 chromatography steps and ultrafiltration to such an extent that media components and residues of the production strain, such as host cell proteins and endotoxins, are separated as far as possible.

 

The process development is followed by the production of the phages as active pharmaceutical ingredients in accordance with the requirements of the pharmaceutical quality assurance system GMP. For this purpose, a master phage stock or master cell bank is first created for each individual phage and its production strain, which is then used for initial production as well as later post-production of the phage active ingredient. The production sequence previously developed in the laboratory is scaled up and carried out depending on the concentration of the phage in the culture supernatant, its yield after purification, its stability and clinical consumption. After production, each phage active ingredient is filled into aliquots, tested for content, identity, biological activity (potency) and purity and finally released for further processing into magistral preparations by hospital pharmacies via an analysis certificate (CoA) and a quality certificate (CoC).