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

The Expert Working Group who put the document together comes from a variety of countries from across the world. They are a mixture of nurses, doctors and bioengineers, all with a special interest in pressure ulcers. Some have considerable practical experience which is reflected in the text. The authors have also been able to take advantage of information in the International Pressure Ulcer Guidelines recently published by the European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel.

Dr Carol Dealey PhD MA BSc (Hons) RN RCNT
University Hospital Birmingham NHS Trust,
University of Birmingham
Carol Dealey is Senior Research Fellow at University Hospital Birmingham NHS Trust, Birmingham, UK
and University of Birmingham, UK.
Carol has worked and researched in the field of Tissue Viability for over 20 years and was one of the first Clinical Nurse Specialists in Tissue Viability (1987-97). Carol has undertaken a considerable body of research in the subject and has presented at national and international conferences as well as having numerous publications. The 4th edition of her textbook the Care of Wounds is in preparation.
She is Immediate Past President of the European Pressure Ulcer Advisory Panel and was one of their representatives on a joint working party with the USA National Pressure Ulcer Advisory Panel to develop international pressure ulcer guidelines. She was President of the European Wound Management Association 1993/4 and is currently a Council member. She was also Chairman of the Tissue Viability Society from 1996-98. Carol is Editor of the EWMA Journal and on the editorial boards of the Journal of Tissue Viability and International Wound Journal.

This paper will discuss implementation of the information provided in the document into everyday practice. For example, repositioning and the use of pressure redistributing devices are widely used across Europe for the prevention of pressure ulcers. The link between the theoretical information on pressure and the practical application in practice will be discussed for these strategies and for others used in the document. 

Clinicians need to be empowered to understand not only their budgets but those of the healthcare system around them. They will need to audit their clinical activity and demonstrate savings that can be made in terms of bed days and admission avoidance. A new technology should enable good clinical outcome measures, a reduction in overall spend and an increase in capacity or turnover of patients. A business case that demonstrates these outcomes allows clinicians and managers to work to achieve the same goal and is hard not to approve.
This session will consider how these business cases can be developed.  

Ms Stella Vig
Consultant General and Vascular Surgeon
Mayday University Hospital, Croydon
Stella Vig is a Consultant General and Vascular Surgeon
at Mayday University Hospital, Croydon appointed in 2006.
She qualified from the University of Wales Medical School in 1991, with an intercalated BSc in Biochemistry (1988) and gained FRCS in 1994. She completed her MCh under Professor John Dormandy at St Georges Hospital in 2004.
Her research and vascular interests include carotid disease, peripheral vascular disease, management of diabetic foot complications, thrombophilia, wound care and risk factor management.
She is Clinical Lead for General Surgery, Trauma/Orthopaedics and Urology. This has consolidated her interest in service improvement with cost effective care to the benefit of both patients and Trust/PCT.
She is also Foundation and Training Programme Director with an interest in training both at undergraduate and post graduate levels.

According to the International Consensus’ Guidelines for DF, the cornerstone of ulcers’ management are the control of infection, revascularization, offloading, systemic and local care; all of the issues must be addressed to cope with this complex and evolutive pathology, in an integrated model of care.

Infection should be managed as aggressively as possible, both surgically, with an early and aggressive debridement, and with systemic antibiotic therapy, which should be aggressive as well.

The possibility of restoring an adequate blood supply to the foot, by means of endovascular, surgical or combined techniques changed the prognosis of DF in the last ten years, since more than 50% of the patients have an underlying lower limb ischaemia.

Offloading is the cornerstone of therapy for the ulcers located on plantar side, and its application is per se sufficient to heal pure neuropathic lesions.

Local care is the aspect of the DF management that faced the most impressive progress in the last five years: V.A.C.® Therapy demonstrated to be highly effective in the management of both chronic and acute post-surgical lesions in DF, reducing healing time and secondary amputations and, combined with new and promising bio-engineered products and surgical reconstructive techniques changed the scenario for many patients which were otherwise candidated to major amputations.

The document draws on the significant clinical research evidence available and the consensus opinion of the expert working group. Many of these experts met in February 2008 to examine the role of epidemiological studies in the development and evaluation of pressure ulcer prevention programmes. Following this meeting, consensus recommendations were developed to provide guidance on performing prevalence and incidence studies and how to use the data collected to improve standards of care for pressure ulcers. In particular it outlines a systematic approach to evaluating, interpreting and comparing studies. In this presentation, Dr Nils Lahmann will outline the key sections of the document, using his clinical experience in Germany to highlight the issues surrounding prevalence and incidence and how implemen-tation of effective PU prevention strategies can help to reduce PU occurrence.

The strategy developed was:
• specialistic units can activate vacuum assisted closure therapy only after Plastic Surgery consultancy (best possible therapy in difficult wound healing)
• the Health Technologies Evaluation Unit approves the request only after Plastic Surgery consultancy  (centralized control)
• vacuum assisted closure therapy is activated at the requesting clinic, and continues in low-cost clinics if discharge is not possible
• end of vacuum assisted closure therapy and definitive wound closure strategy are decided after Plastic Surgery consultancy.

The need of well trained medical and nursing staff was answered through:
• selection of dedicated professionals to be trained in vacuum assisted closure therapy
• workshops for demonstration of vacuum assisted closure therapy use and efficacy.

The overall cost-effectiveness optimi-zation was completed with the acti-vation of an early discharge strategy to home care with specifically vacuum assisted closure therapy trained nursing staff for patients living at <60 km from the hospital, or transfer to low-cost clinics of patients living at >60 km.

Our results were:
• optimization of cost-effectiveness
• increasing good opinion of vacuum assisted closure therapy clinical efficacy
• well trained staff
• in/out patients ratio inversion.

Methods: Eighteen outpatient wound centers in 11 U.S. States using the Intellicure electronic medical record (EMR) contributed to the Intellicure Research Consortium (IRC) database. Analyses were based on data collected between 8/31/2001 and 11/24/2006 from 9,119 patients with 20,371 wounds involving 161,913 outpatient visits. From these data, 931 patients (~10 %) received vacuum assisted closure therapy.
AE surrogates such as infection, peri-wound complications, change or increase in exudate, wound cultures, pain and antibiotic medication prescriptions were used to determine whether the incidence of AEs differed between the treatment groups. Data were stratified by ICD-9 diagnosis code, wound size, and wound duration.

Results: Compared to moist wound care patients treated with vacuum assisted wound closure therapy with acute traumatic wounds (ATW) and pressure ulcers (PU) experienced fewer presumed infections (p=0.006 and 0.005 respectively). Amount and type of drainage were decreased for ATW (p<0.001), PU (p=0.004), and subacute flaps and grafts (p=0.034). Periwound complications were significantly less for ATW (p<0.001) and PU (p=0.014). Antibiotic prescription rates were reduced among chronic diabetic foot ulcers (p=0.036) and ATW (p=0.016), and no difference in the number of pain medication prescriptions were observed. There were no cases of hospitalization or deaths related to vacuum assisted wound closure therapy. A surprising 9.6 % of patients on vacuum assisted wound closure therapy were on heparin or warfarin and none experienced bleeding.

Conclusions:Among 931 patients on vacuum assisted wound closure therapy, depending on wound type, there was either no statistical difference in the frequency of AE surrogates compared to patients on moist wound are, or patients on vacuum assisted wound closure experienced significantly fewer AE surrogates. This study suggests that vacuum assisted wound closure is safe for outpatient use in all wound
types evaluated.

This document has resulted from a group of broad based, clinical and academic disciplines representing a large number of countries coming together to debate issues around this therapy and by an iterative process producing a document that has been approved by all members of the group.This document summarises evidence, and experiences of a wide range of individuals and helps to identify what, where and how this therapy should be used. In addition to identifying key aims of treatment when using this therapy, factors that increase the chances of success are also outlined. Ongoing evaluation of treatment is essential as an understanding of what may adversely affect patient outcome. Reviews of published work and individuals’ experiences on 3 examples of chronic wounds – diabetic foot ulcers, complex leg ulcers and pressure ulcers, in addition to 3 examples of acute wounds – dehisced sternal wounds, open abdominal wounds and traumatic wounds are presented in this document.
Finally this document suggests how to measure the impact of this treatment and it is genuinely believed that this process of consensus building will help to move the subject of wound healing and the use of this form of therapy forward in an appropriate manner.

Vaccuum assisted closure: recommendations for use - a consensus document

Click to download the consensus document (english version) French version Spanish version Italian version German version

Now negative pressure therapy has penetrated the traumatology field, war surgery, thoracic surgery, abdominal surgery and craniofacial surgery. Exposed bones, tendons, vessels, pericardium and pleura can be safely covered by using this technique with a non-adherent interposed layer. Soldiers injured during battles in Iraq and all conflicts in the world have their lives saved daily by the possibility of extracting them from the battlefield and transporting them using negative pressure therapy as covering dressing to a specialized center.
Debridement, promotion of granulation tissue and wound coverage using dermal substitutes and skin grafts or skin substitutes are enhanced by NPWT. Vacuum assisted closure therapy is also proposed during the post-operative period of dehiscent flaps, or in any subcutaneous cavity wound, where dead space is the open door to infection. The permanent suction effect and its modularity are strong arguments to extend the use of vacuum assisted closure therapy to most of the surgical procedures where mild complications may lead to secondary infection and loss of tissue.

Objectives
Recording the patient-defined benefits and the QoL of patients undergoing TNP treatment in clinics and in home care.

Methods
Multi-centre, open, uncontrolled observational study all over Germany. Consecutively, data were collected on n=264 patients with any kind of acute or chronic wound before and after TNP. Major outcomes parameters were wound status, disease-specific quality of life (evaluated by the Freiburg Life Quality Assessment, FLQA-w) and patient-defined benefits, the latter assessed with the patient benefit index (PBI), a questionnaire specifically developed for the evaluation of therapeutic patient benefits.

Results
The mean disease-specific QoL improved significantly from 3.3 ± 0.7 to 2.6 ± 0.7 (higher values represent greater disease burden; p <0.001). Significant improvements were also noted in individual aspects of QoL: physical complaints, psychological well-being, daily life/working life, social life and therapy (p<0.001 for each
aspect). Satisfaction with treatment was high, only 5.7 % of patients feed-backed major problems with the therapy, e.g. noise and mobility. The most important patient-defined benefits initially mentioned included the recovery of function in activities of daily living, reduction in treatment burden (doctor/clinic visits), and gaining trust in the therapy, along with healing of the wound and lack of pain. These aims were achieved in a majority of the patients after vacuum assisted closure therapy. About 87 % of the patients showed a PBI >1, indicating a substantial therapeutic benefit.

Conclusion
Patients with chronic wounds express a wide range of objectives for therapy, which must be considered when evaluating the therapeutic benefits. The data underline that TNP therapy leads to significant improvement of QoL and patient benefits in acute and chronic wounds.