This system allows these fluids to stay for a predefined period in contact with the wound and are taken out due to the activity of the vacuum system. In our clinic we gained experience with saline solution as instillation solution. It showed up that application of this system we could successfully treat complex infected pressure ulcers.
Based on the experiences in infected wounds we were interested to see if the V.A.C. Instill® System also could be effective for treatment in contaminated but not infected wounds. We decided not only to look to clinical results like wound healing efficacy but also to immunohistochemical parameters for: neoangiogenesis, growth factors and a reduction in the presence of macrophages, like CD34, ACTINA, EGFR and CD68.
Unfortunately we were able to treat only 5 patients at this moment so the results are very preliminary. However we see more neoangiogenesis activity and a more effective reduction of macrophage activity. Also clinically we saw satisfying results.
Conclusion: V.A.C. Instill® Therapy can be an effective treatment for infected wounds but also for contaminated wounds. As the amount of collected data in non-infected wounds at this moment is too small for final conclusions it can be stated this therapy is very promising. More research however is necessary. 

Dr. Manlio Ottonello, MD
Plastic Surgeon,
Pietra Ligure, Italy

Education
1987 Graduation in Medicine and General Surgery University of Genoa,
Italy
1994 Specialization in Plastic and Reconstructive Surgery University of
Genoa, Italy
2000 Specialization in Hand Surgery and Surgery of the Upper
Extremities, University Pierre e Marie Curie, Medical Faculty Saint
Antoine, Paris, France

Working Experience and Positions

Held 1985/1987 internship General Surgery Department and Department of Hand
Surgery San Paolo Hospital Savona, Prof. Renzo Mantero
1988/1989 official Head of the Medical Department of the Marine Military,
specialized and qualified for the care regarding the Hyperbaric
Chamber at Military Hospital and Military Arsenal, La Spezia, Italy
1989/1991 Specialist in internal medicine at the Department of Plastic Surgery
Santa Corona Hospital, Pietra Ligure, Italy
1991/1999 Assistant physician (resident) at the Department of Plastic and
Reconstructive Surgery, Santa Corona Hospital, Pietra Ligure, Italy
Full time responsibility regarding general surgery, emergency room
and wards
Apr-Sep1999 Resident at the “Institut de la Main”, Prof. A. Gilbert, Paris, France
Oct 1999 - Head of the Department (first level) for Plastic and Reconstructive
Dec 2000 Surgery of the Spinal Cord Unit, Santa Corona Hospital, Pietra
Ligure, Italy
Jan 2001 Head of the Department for Plastic, Reconstructive and
present Rehabilitation Surgery
Responsible physician of the ambulatory for “difficult wounds”

Dr. Ottonello is a member of various societies and associations in the field of plastic, aesthetic and hand surgery and EPUAP and Wound Infection Institute. He has further presented at various national and international conferences regarding Plastic and Reconstructive Surgery, Hand Surgery and Wound healing as well as has given numerous lectures at a.o. the Nurse’s Training School.

Main principle of infection surgery has always been radical debridement. “Ubi pus, ibi evacua”, often cited by surgeons is not enough. All necrotic and infected tissue should be resected in case of limb or life threatening infections. Surgical and sharp debridement has become the gold standard, especially in complicated skin and soft tissue infections, whereas in chronic wounds alternative techniques (mechanical, enzymatic, autolytic and biological debridement, honey) may be more appropriate.

Wound irrigation can be helpful, but has no effect on remaining pathogens. HPPL may be deleterious by causing bacterial penetration into depth of tissues, while instillation of antiseptic fluids into a wound has an ongoing effect, when it´s used for a longer time, and when the antiseptic agent remains in the wound for at least 20 minutes. For more than seventeen years the V.A.C.® Therapy System has been used succesfully in treating wound infections. Preparing wounds for closure means to clean wounds, to achieve wound retraction and minimize following surgical procedures.

When infection is under control, the wound should be closed at the earliest time possible. Sometimes a simple split-thickness skin graft may be suitable for wound closure. In case of exposed bone, orthopaedic hardware, the use of local, pedicled and free flaps including microsurgical procedures is essential not only for wound closure but also for infection control. Well perfused tissue of the flap serves as carrier of systemic antimicrobial agents, which are absolutely necessary to kill remaining pathogens at the site of infection. Infection control can be difficult or even impossible in case of insufficient debridement, persistence of bacteria, and insufficiency of antimicrobial agents in case of multidrug-resistant (MDR) bacteria like MRSA and Acinetobacter Baumannii. Instillation technology is able to combine and optimize the effects of permanent elimination of bacteria by NPWT and to kill and wash out pathogens by cyclic instillation of antiseptic fluids.

The V.A.C. Instill® System enables a 3 stage-working cycle. Vacuum therapy / instillation of antiseptic fluids / hold time. Our experiences of treatment of infected wounds include chronic wounds with local infection, acute infections originating from chronic wounds as well as limb- and lifethreatening infections caused by MDR bacteria. In some patients NPWT and Instillation Technology were used as a salvage procedure following failure of multiple plastic surgical procedures. One thing was equal in all patients. Debridement and subsequent plastic surgical procedure seemed to be insufficient for infection control, or time to closure seemed to be to early. We have always been using Polyhexanid (Lavasorb®) for instillation. Instillation time directly depended on wound size. Time of therapy lasted at least 4 days, at most 18 days.

Dressing changes were performed every two to four days. Surgical closure was performed by direct secondary suture, skin grafting or flap surgery. In all cases infection control and complete healing were achieved, despite of incomplete debridement and leaving Prolene-Mesh® in situ in two cases. We believe the V.A.C. Instill® Wound Therapy System to be a useful tool for infection control in difficult anatomical regions (e.g. open wrist and talocrural joint), in case of impossibility of total debridement and MDR bacteria.

Prof. Dr. Michael Schintler
Department of Plastic and Reconstructive Surgery
University Clinic Medical School Graz, Austria

Qualifications
2008-date Head of Burns Team, University Clinic of Surgery,
Department for Plastic and Reconstructive Surgery
2000 to date Head of Outpatient Clinic for Diabetic Foot Patients
University Clinic of Surgery,
Department for Plastic and Reconstructive Surgery
2000-2001 Consultant for Trauma Surgery
1995-2000 Consultant for Plastic and Reconstructive Surgery
Clinical Department for Plastic Surgery
Medical University Graz, Austria
1988-1992 General Practitioner, District Hospital Klagenfurt, Austria
1981-1988 M.D., Medical University Graz, Austria

Employment History
Jan 1998-date Staff Surgeon, Department of Plastic and
Reconstructive Surgery, Medical University Graz
Jan 1995-Dec 1997 Surgical Residency
Department of General Surgery, Medical University Graz
1992-1995 Surgical Residency , Department of Trauma Surgery,
Regional Hospital Hermagor
1988-1992 General Practitioner Training, District Hospital Klagenfurt
Teaching
1998-2007 Courses and Seminars; Certified Woundmanager, Austria,
Germany, Switzerland; Kammerlander Consulting.
2003-date AO- Courses, University Clinic of Trauma Surgery,
Flap – Courses with Cadaver dissections, Institute of Anatomy,
Medical University Graz
2000-to date Theoretical, practical and clinical teaching to the
postgraduate students at the University Clinic of Surgery

For more than seventeen years the V.A.C.® Therapy System has been used successfully in treating wound infections. Preparing wounds for closure means to clean wounds, to achieve wound retraction and minimize following surgical procedures. When infection is under control, the wound should be closed at the earliest time possible. Sometimes a simple split-thickness skin graft may be suitable for wound closure. In case of exposed bone, orthopaedic harware the use of local, pedicled and free flaps including microsurgical procedures is essential not only for wound closure but also for infection control. Well perfused tissue of the flap serves as carrier of systemic antimicrobial agents, which are absolutely necessary to kill remaining pathogens at the site of infection. Infection control can be difficult or even impossible in case of insufficient debridement, persistence of bacteria, and insufficiency of antimicrobial agents in case of multidrug-resistant (MDR) bacteria like MRSA and Acinetobacter Baumannii.

Instillation technology is able to combine and optimize the effects of permanent elimination of bacteria by NPWT and to kill and wash out pathogens by cyclic instillation of antiseptic fluids. The V.A.C.-instill® System enables a 3 stage-working cycle. Vacuum therapy / instillation of antiseptic fluids / hold time. Our experiences of treatment of infected wounds include chronic wounds with local infection, acute infections originating from chronic wounds as well as limb- and lifethreatening infections caused by MDR bacteria. In some patients NPWT and Instillation Technology were used as a salvage procedure following failure of multiple plastic surgical procedures. One thing was equal in all patients. Debridement and subsequent plastic surgical procedure seemed to be insufficient for infection control, or time to closure seemed to be to early. We have always been using Polyhexanid (Lavasorb®) for instillation. Instillation time directly depended on wound size. Time of therapy lasted at least 4 days, at most 18 days. Dressing changes were performed every two to four days. Surgical closure was performed by direct secondary suture, skin grafting or flap surgery. In all cases infection control and complete healing were achieved, despite of incomplete debridement and leaving prolene mesh® in situ in two cases. We believe the VAC-instill® Wound Therapy System to be a useful tool for infection control in difficult anatomical regions, (e.g. open wrist and talocrural joint) in case of impossibility of totally debridement and MDR bacteria.

The recognition of bacterial biofilm in chronic wounds may give us the opportunity to explain many of the characteristics of the chronic wound. It may explain why a chronic wound doesn’t heal despite adequate treatment of underlying condition.

The bacterial biofilm interfere with the human immune system in numerous ways. This may cause inflammation and necrosis in the chronic wound and may prevent healing. It is tempting for the clinician to start antibiotic treatment, but in case of established, mature biofilm, this treatment often has only a temporary effect on both inflammation and healing. The bacteria in biofilm are up to 1000 times less susceptible to antibiotics(2). Even silver treatment, as incorporated in several wound dressings, has limited effect in biofilm in vitro(3).
Our research group have developed and recently filed a patent on buffered acetic acid for the treatment of bacterial biofilm. It has shown a remarkable effect on even mature bacterial biofilm in vitro and promising results in early clinical trials. We will present the in-vitro results and some clinical case stories.

Reference List

(1) Hoiby N, Bjarnsholt T, Givskov M, Molin S, Ciofu O. Antibiotic resistance of bacterial biofilms.
Int J Antimicrob Agents 2010 Feb 8.
(2) Stewart PS, Costerton JW. Antibiotic resistance of bacteria in biofilms.
Lancet 2001 Jul 14;358(9276):135-8.
(3) Bjarnsholt T, Kirketerp-Moller K, Kristiansen S, Phipps R, Nielsen AK, Jensen PO, et al.
Silver against Pseudomonas aeruginosa biofilms. APMIS 2007 Aug;115(8):921-8.

Dr. Klaus Kirketerp-Møller
Consultant
Orthopaedic department
Køge University Hospital
Lykkebækvej 1
DK-4600 Køge

July 1989 Medical Doctor - Copenhagen University, Denmark
March 2001 - Speciality of Ortopaedic Surgery
January 2005 -  Consultant Surgeon, Copenhagen Wound Healing Center
June 2007 - Clinical Head, Copenhagen Wound Healing Center
December 2009-present  - Consultant, Orthopaedic dept. Køge University Hospital

Medical society:
   
Chair of Danish Association of The Diabetic Foot (2007-2008)
Membership:
- Danish Orthopaedic Society
- Diabetic Foot Study Group
- European Bone and Joint Infection Society
- Danish Wound Healing Society   

Scientific Work
Reference List

 1.  Thomsen, T. R., Aasholm, M. S., Rudkjobing, V. B., Saunders, A. M., Bjarnsholt, T., Givskov, M., Kirketerp-Moller, K., and Nielsen, P. H. (2010) The bacteriology of chronic venous leg ulcer examined by culture-independent molecular methods. Wound.Repair Regen. 18[1], 38-49
 2.  Fazli, M., Bjarnsholt, T., Kirketerp-Moller, K., Jorgensen, B., Andersen, A. S., Krogfelt, K. A., Givskov, M., and Tolker-Nielsen, T. (2009) Nonrandom distribution of Pseudomonas aeruginosa and Staphylococcus aureus in chronic wounds. J.Clin.Microbiol. 47[12], 4084-4089
 3.  Kirketerp-Moller, K. and Gottrup, F. (2009) [Bacterial biofilm in chronic wounds]. Ugeskr.Laeger 171[13], 1097
 4.  Kirketerp-Moller, K., Jensen, P. O., Fazli, M., Madsen, K. G., Pedersen, J., Moser, C., Tolker-Nielsen, T., Hoiby, N., Givskov, M., and Bjarnsholt, T. (2008) Distribution, organization, and ecology of bacteria in chronic wounds. J.Clin.Microbiol. 46[8], 2717-2722
 5.  Bjarnsholt, T., Kirketerp-Moller, K., Jensen, P. O., Madsen, K. G., Phipps, R., Krogfelt, K., Hoiby, N., and Givskov, M. (2008) Why chronic wounds will not heal: a novel hypothesis. Wound.Repair Regen. 16[1], 2-10
 6.  Laurinaviciene, R., Kirketerp-Moeller, K., and Holstein, P. E. (2008) Exostectomy for chronic midfoot plantar ulcer in Charcot deformity. J.Wound.Care 17[2], 53-58
 7.  Bjarnsholt, T., Kirketerp-Moller, K., Kristiansen, S., Phipps, R., Nielsen, A. K., Jensen, P. O., Hoiby, N., and Givskov, M. (2007) Silver against Pseudomonas aeruginosa biofilms. APMIS 115[8], 921-928
 8.  Kirketerp-Moller, K., Balslev, N., and Lohmann, M. (1996) [Accidents caused by inflatable bouncers in 0-19 year-olds in Denmark in 1993]. Ugeskr.Laeger 158[16], 2251-2253
 9.  Blond, L., Kirketerp-Moller, K., Sonne-Holm, S., and Madsen, J. L. (2002) Exsanguination of lower limbs in healthy male subjects. Acta Orthop.Scand. 73[1], 89-92
 10.  Boel, J. and Kirketerp-Moller, K. (1993) [Clinical result after Leeds-Keio reconstruction of the anterior cruciate ligament]. Ugeskr.Laeger 155[26], 2049-2052
 11.  Kirketerp-Moller, K. (1991) [Acute compartment syndrome after a brief march]. Ugeskr.Laeger 153[29], 2071-2072

Methods
Medline-, hand-search for NPWT literature. Used filter were “randomized”, “future” (what about NPWT as a filter?). Analysis of the literature for recently produced evidence according to the criteria of evidence-based medicine (EbM). Additionally, literature, dealing with the experimental basis of NPWT was analysed. Survey 2006 and 2008 at the “3-Länder”-congresses (Nürnberg, Graz) dealing with the application methodology of NPWT. Furthermore some reflections about future necessities for the development of importance of NPWT in wound treatment were added.

Results
Between 2007 and 2010 eight randomized controlled trials (RCT) were published. Medical progression could be shown in patients with open fractures (surgical site infection rate: minus 80%) and with diabetic foot syndrome (DFS; time to granulation: minus 40%, wound closure: plus 50%, faster healing). Generally, a tendency to shorter duration of therapy could be demonstrated in wounds. An economical progression was calculated for DFS patients. Unfortunately some RCT’s were based on very small patient groups or on a secondary analysis of patients enrolled in other RCT. In order to develop wound treatment further, it is important to create an Excellence Center of Wound Therapy giving support to clients (patients or customers?) by constantly evolving guidelines, technical advices, algorithms. E.g., against the background of the results of both above mentioned surveys, it is necessary to teach an individualized (what does this mean?) adaptation of the negative pressure value. There is a need to reduce the pressure particularly in those tissues sensitive to hypoxia like subcutaneous tissue, tissue after microcirculation injury, wounds after fasciotomy, DFS. Additionally, algorithms to define the beginning and the end of NPWT integrated into the wound therapy, have to be formulated for all indications. To further develop wound treatment it is important to use a multidisciplinary approach to future R&D activities. In an Invention Center, all components of NPWT have to be considered scientific challenges. For example, the avital synthetic foam has to be transferred to a biologically active interface; for home treatment a 24h surveillance using wireless-technology (principle: “never alone“) could be implemented and wound therapy data and images can be transferred online and in real time to all players like physicians surgeons in the hospital, Health-Technology-Assessment (HTA)-institution and caregivers. Beyond the scalpel and the wound, , new technologies to communicate and to spread out the knowledge need to be developed.
In order to progress with wound treatment it is important to be responsible in contributing with high evidence of new inventions according to the criteria of EbM. There is a need to cooperate very early in a deep collaborative relationship with HTA-centers to provide earliest proof of high evidence of the new invention.

Conclusions
The latest RCT’s showed medical and economical progression by NPWT only within two indications (which ones?). Even if literature and empiric knowledge show that NPWT created a paradigm shift in many indications of wound treatment, today’s low evidence of NPWT is a great deficit. Nevertheless, there is no doubt that NPWT and its modificationssuch as instillation therapy, will play an important role in the innovation of wound treatment. If we want to widen the scope, it is necessary not to respond to trends (technical, medical, social, statistical, …) but to shape and lead them. Support by modern knowledge, safety features, realization of results of multidisciplinary research and self-motivated HTA activity allow it to surprise patients, surgeons and care-givers with innovations that create a benefit for both the patients and the society. 

LtCol Prof. Christian Willy, MD
Professor of Surgery
Military Hospital Ulm
Federal Armed Forces of Germany
Oberer Eselsberg 40
89075 Ulm

Chairman Surgical Center
General Surgeon,Trauma Surgeon

 
Clinical main topics:
- Healing of complex wounds
- Acute and chronic compartment syndrome
- Pelvic trauma
- Spine trauma
- Surgery under military and catastrophic conditions

Organisational main topics:

- Surgical training programs (Medical service Federal Armed Forces, German Society of Surgery)
- Quality Management
- Students
- Coordination Surgical Research
- Speaker Advisory Board Surgery (Ministry of Defense)
- Coordination Deployment Surgery Germany

Scientific main topics:

- Wound healing
- Vacuum-assisted therapy
- Acute and chronic surgery
- Wound drainages
- Soft tissue injuries
- Pathophysiology of extremity injuries
- Importance of Non-Linear Dynamics in Surgical Research
- Epidemiology of Deployment Surgery

 
Born 06 Oct 1962

1981   University of Ulm
1987   Approbation as a medical doctor
  MD-Thesis: Outcome of lysis therapy (Urokinase) of chronic peripheral arterial occlusive disease
 
1987 – 1996 Resident Time in Surgery

1990 – 1993 Military Service

1992 – 1993 University of Munic (Studies in Theory of Science, Logic and Philosophy)

1998  Senior Consultant in Surgery

1999 – 2000 Fellowship TraumaCenter University of Zurich, Switzerland

2000  PhD Thesis: ICP Monitoring in Chronic Compartment Syndrome

2003  Fellowship TraumaCenter University of Victoria, Melbourne, Australia

2007  Professor of Surgery

2008  Speaker Advisory Board Surgery (Ministry of Defense)

1997 – 2009 Missions in Sarajewo / Bosnien-Herzegowina (SFOR) Prizren / Kosovo (KFOR) Kabul, Kunduz, Fayzabad and Mazar-e-Sharif / Afghanistan (ISAF)

Member German Society of Surgery (DGC)
Member German Society of Trauma Surgery (DGU)
Member German Society of Military Medicine and Pharmacy (DGWMP)

Material and Methods: The V.A.C. Instill® enables a 3 stage-working cycle. Vacuum therapy / instillation of antiseptic fluids / hold time. We have always been using Polyhexanid (Lavasorb®) for instillation. 15 patients with severe diabetic foot infections were treated with V.A.C. Instill®. All patients presented with limb or even life-threatening infections. Debridement and following plastic surgical procedure seemed to be insufficient for infection control, or time to closure seemed to be to early. Instillation time directly depended on wound size. Time of therapy lasted at least 6 days, at most 12 days. Dressing changes were performed every two to four days. Surgical closure was performed by direct secondary suture, skin grafting or flap surgery.

Results: In all cases infection control and complete healing was achieved, despite of incomplete debridement and even long lasting open Charcot joints.

Conclusion: We believe the V.A.C. Instill® to be a useful tool for infection control and limb salvage in severe diabetic foot infections and in case of impossibility of totally debridement. Early defect coverage and hospital discharge could be cost-effective.