A number of published studies have considered the economic and clinical outcomes associated with the use of vacuum assisted closure therapy in home health settings in the United States. However, uptake in home health settings outside of the United States remains relatively limited, largely on financial grounds. Barriers to uptake include limitations in the evidence base, difficulties associated with the virement of funds across care settings and perverse incentives introduced by reimbursement and coverage procedures. Healthcare planners are encouraged to consider how each of these barriers can be addressed to improve the efficiency of wound management.

This literature review will discuss the clinical outcome of diabetic foot ulcers treated with vacuum assisted closure therapy, its implication in the transition from acute care to home care, factors that might influence clinical outcome in home care, and the quality of life aspects in these patients. Patient care for diabetic foot ulceration is complex and necessitates multidisciplinary collaboration to provide comprehensive wound care. It is critical for limb-preservation in this most high-risk population to have available a versatile, efficacious wound healing modality that can easily transition from acute care to home care. Finally, combining vacuum assisted closure therapy with other wound healing resources in a collaborative and synergistic fashion allows patients to continue with daily living activities, while receiving all the potential benefits of an advanced wound healing modality.

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. 

The following presentation will use the model of hard-to-heal DFUs, in which the most significant factors related to high cost have been identified as number of surgical procedures, in-patient hospital stay and time to healing as well as the consequences of amputation. The estimated cost of treating a DFU in the USA is up to US $20,000 and a major limb amputation costs about US $70,000. Recent estimates reveal that DFUs and
amputations alone cost the USA healthcare system about US $30 billion yearly. Lower extremity complications account for approximately 15–40% of the total cost of diabetes in most countries.
Resource utilization and economic cost in DFU were analyzed based on people with diabetes with post amputation ulcers (up to the Tran metatarsal level) enrolled into a sixteen-week, randomized clinical trial. Patients randomized to vacuum assisted closure therapy received therapy with dressing changes every 48 h. Control patients received standard MWT according to consensus guidelines. Resource utilization and procedures were analyzed using a standardized protocol.
Treatment of diabetic wounds using vacuum assisted closure therapy compared to MWT was associated with substantially lower resource utilization with regard to out-patient visits, dressing changes, surgical procedures and antibiotics. Overall direct treatment costs were also substantially different between the two groups, where
treatment with vacuum assisted closure therapy  was on average $8,800 less than with MWT.
In summary, this study revealed that treatment with vacuum assisted closure therapy  resulted in healing at a lower overall cost of care and further illustrates the challenges in doing health economic studies in wound care.