Introduction

Copenhagen, Denmark, was the host city for the 2016 International Negative Pressure Wound Therapy (NPWT) Challenging Wounds Expert Meeting, sponsored by Smith & Nephew. This was an international meeting, welcoming more than 170 delegates and 12 speakers, from Europe, America, the Middle East, Canada, Africa, Asia and Australia.

Challenging wounds are defined as those that are slow to heal or have stopped healing completely. Estimates from the literature suggest that one-third of patients with wounds have had them for over six months.¹ Some of the speakers had clinical experience of managing patients who had suffered with wounds for many years. Chronic wounds cause pain, anxiety and reduced quality of life for patients, as well as considerable treatment costs to the health services. Indeed, the estimated cost of treating wounds in the UK, for example, is between £2.3 and £3.1 billion per year, accounting for around 3% of the entire healthcare budget.² Most wound care is carried out in the community.

NPWT is an innovative wound-management strategy that can increase the efficiency of wound treatment by reducing the number of dressing changes and nurse visits required, as well as reducing time to heal.^3,4 With the latest improvements in technology, NPWT devices have become smaller and more portable, which allows patients to continue with their normal daily activities. This meeting reviewed the current evidence and opportunities of using single-use NPWT in the community to try to help kick-start these long-standing challenging wounds towards healing.

Introduction to single-use negative pressure

NPWT is a proven and effective wound therapy system that heals wounds by applying negative pressure to the affected area.⁴ But how does it work? As Professor Hanne Birke Sørenson explained, NPWT has multiple modes of action. The most obvious role is as a barrier to the surroundings in both directions, protecting the wound from drying outwards to the atmosphere and preventing incoming infection. NPWT stabilises the wound, encourages the formation of granulation tissue and encourages fluid removal, ultimately leading to fewer dressing changes and faster wound healing.⁵

All of these various actions of NPWT together reduce the size of the wound, reduce its complexity and reduce the need for further treatments and hospitalisation.⁵ Crucially, they reduce patient discomfort, increasing the mobility of the patient and improving their quality of life.⁵

Is there a role for single-use NPWT devices in the community?

Another important benefit of improving wound healing is to reduce the cost of treatment. Wound care treatment is very expensive, taking up a high percentage of community nursing time and accounting for approximately 3% of total healthcare expenditure.⁶ In her presentation, Jeanette Milne explained that with earlier discharge of patients from hospital post-surgery, increasing incidence of obesity and longer life expectancy, the community nursing service is faced with increasingly complex wounds to manage and a staff of fewer nurses. Recent developments in NPWT technology have led to the introduction of single-use NPWT devices, which are smaller and more portable. The audience was asked to consider if these single-use NPWT devices could help to ease the cost and time pressures of community nurses and if they should be made widely available.

One of the biggest barriers to the adoption of single-use NPWT devices in the community is funding.⁷ Although they ultimately offer potential cost savings, they may be considered expensive on a simple unit-to-unit comparison with standard wound care dressings. Insufficient training can also be an issue meaning that some community nurses are not comfortable initiating NPWT for their patients. Furthermore, poor communication between the hospital and community can mean that there is little advance notice before discharge of patients already on NPWT.

‘We have a duty to educate rather than just inform’ Jeanette Milne

Jeanette Milne explained that the key to success with NPWT in the community is selection of the right patients, not only in terms of wound type, but also home environment and the patient’s ability to manage the technology. It is also important to define the treatment pathway and goals before starting therapy in order to manage everyone’s expectations. Tools exist to help use NPWT in the community, including defined patient pathways for venous leg ulcer (LU) management.⁸ Smith & Nephew have developed a simple calculator in a format similar to the ankle brachial pressure index charts. It allows nurses to calculate the wound area (Figure 1A) and establish how the size changes with treatment (Figure 1B).

 

What is the impact of single-use NPWT on human factors?

When selecting a treatment, perhaps the most important factor is patient comfort. In her presentation, Dr Ann-Mari Fagerdahl discussed factors of concern for the patient. Even though the canister-based NPWT systems are designed to be mobile, many patients find them heavy and inconvenient. Also, some patients dislike the noise of the machine because it disturbs the sleep of themselves or their partner, while others are worried by the alarms and the urgency to change the dressing if the machine malfunctions for over two hours. For some, the obvious visibility of the medical equipment is the biggest concern, leading to isolation, stigma and discomfort around family and friends. In addition, the machines require maintenance and replacement components.

The availability of smaller and more portable NPWT systems can have a substantial impact on the quality of life of patients. Single-use NPWT systems, such as PICO^◊, are more discrete as they do not have a canister and the pump unit is small enough to fit in a pocket.⁹ A major factor of concern among patients is whether NPWT is painful. Removal of the foam can be painful, but alternatives that have lower adhesion such as gauze are available and dressings made from silicone that would not stick are also under investigation.

Q&A Is there an optimal area beyond the wound that should be targeted with NPWT? All non-healthy tissue around the wound should be considered as being at risk in the opinion of the panel. Has self-management of patients with NPWT been explored? This may be the next step for patients who wish to participate in their care. However, there may be issues with the skill required to create a perfect seal around the dressing and there may be a level of fear among nurses of letting go.

Improving efficiency in wound care

Healthcare provision is complex and dependent on multiple interdependent pathways and processes. There is a lot of scope for improving efficiency by improving how the different parts fit together. The second session in the meeting discussed one approach to improving efficiency, ‘lean thinking’, and how it could be applied to healthcare provision and community healthcare in particular.

Lean thinking in healthcare

All industries are under pressure to become more efficient and healthcare is no different. Professor Daniel Jones is an expert on lean thinking, which he explained is not a recipe for cost cutting, but rather an improvement pathway. He applied to healthcare the same scientific approach he would use to diagnose and solve organisational problems in businesses from other sectors.

Professor Jones presented five interdependent key insights:

1. Shift the focus from provider to patient because it is important to recognise patients are the customers even though they are not paying for services directly. The demand for healthcare is highly predictable and it is the way that it is run that creates the chaos and peaks and troughs.
2. Collaborate along the patient journey to identify the point of critical delay that is preventing the smooth running of the system. For example, the biggest queue is often the one to leave the hospital system.
3. Deepen knowledge of the process to understand the causes of interruptions to the service. Make the work visible, ie defining a plan for the journey of every patient in every ward to achieve ‘right first time’ every time.
4. Improve staff fulfilment by giving staff responsibility for defining their work and improving their system. Encourage them to establish local standards rather than comparing to international best practice.
5. Get leaders actively engaged by showing them the front line. They must manage from the ground up to give clear direction, unblock obstacles and support experiments. This will provide teams with everything they need to succeed every day.

Moving forward, the challenge is to develop new ways of delivering care for the future that combine the capabilities of technology with robust processes. Professor Jones anticipates that healthcare will change to deliver more activities around the patient’s home, such as telemedicine. The biggest obstacle is likely to be the financial accounting system because the bills are paid regardless of whether the system is efficient or not. It will be critical to engage the financial accounting system in understanding the process of cost versus benefit.

‘The quality of the process is as important as the quality of the healthcare’ Professor Daniel Jones

Can we apply lean methodology in primary care?

Within primary care, there are opportunities to improve the flow and efficiency through lean methodology. In many cases, processes can be made more efficient by simplifying complex tasks and taking choice out of the system. Jeanette Milne illustrated this with two examples from her own clinical experience in primary care.

Example 1: Referral process to LU team

• Referring a patient to the community nurse was required to transfer information from the electronic patient record to a hand-completed 11-page referral form
• Led to duplication of work, frustration and conflict
•  Administration time eight hours
• Frequently waiting for over a week for information for referral before review.

Change in practice:

• Process simplified to embed the electronic record within referral
• Form to complete reduced to two pages
• Administration time 10 minutes
• Referral to review reduced to five days.

Impact on the quality of the process:

• Improved three of eight wastes of the Lean Six Sigma (Table 1).

To look for potential areas of improvement, it can be helpful to invite a peer from another region to review the system. The future use of barcodes on patient wristbands will also allow better visibility of their pathways through the system.

Wound management for the 21st century: combining effectiveness and efficiency¹¹

Christina Lindholm explained that wound management is expensive. The cost of treating pressure ulcers alone in the USA is estimated to be $11 billion per year and up to €6 billion per year in Europe for diabetic foot ulcers (DFUs). With demographic changes, increased prevalence of long-term conditions and higher patient expectations, this demand will continue to grow. In the UK, the cost of wound management services is expected to rise by over £200 million annually from 2014 to 2019.¹¹

‘Dressing costs are low compared with nursing time’ Professor Christina Lindholm

Most wound patients (70–80%)¹¹ are treated in the community as a product of policies of earlier discharge from hospital. Patients require an average of three dressing changes per week, which takes up 60% of community nursing time. It is a common misconception that wound dressings are the major cost driver in wound management. In fact, nursing time and hospital costs together account for up to 85% of the total cost of wound care.

The three main drivers of the cost of wound care are shown in Figure 2.

1. Time it takes to heal a wound. Some patients suffer with wounds for many years – 72 years was the longest in Professor Lindholm’s clinical experience. Reducing this healing time by kick-starting the healing process among static, non-healing wounds will reduce cost, and most importantly, patient suffering.
2. Frequency of dressing changes. Advanced wound healing systems cost more per unit but can require fewer changes. Professor Lindholm showed a calculated example of how reducing the dressing change to once a week in 30% of patients would be expected to save 22 300 nursing hours a year in a community of a million people.
3. Incidence of complications. Complications such as infection post-surgery lead to extensive use of resources and antibiotics. Infection following breast cancer surgery can delay chemotherapy or radiotherapy. NPWT can help to manage complications or avoid them altogether. In a meta-analysis, the risk of surgical-site infections (SSIs) in high-risk patients fell by 46% with the use of NPWT over standard care.¹²

The challenge is how to reconcile increasing patient demands with scarce community nurse resources. This evidence suggests that we must set goals of optimal healing, fewer dressing changes and fewer complications. To be successful, these strategies need to be supported at both a political and a local level.

Q&A What is the best way to convince management of the benefit of PICO◊ if they look only at the cost per unit? The panel suggested showing them photos of the most shocking cases. Taking patients to meet with the leaders can also be appropriate in certain cases.

Complicated post-surgical wounds: impact and treatment in the community

Single-use NPWT on closed incisions: giving high-risk patients the best chance

A significant proportion of SSIs appear after discharge from hospital and are managed by community nurses.¹³ NPWT can be used to treat these complications and reduce time to healing. ¹² NPWT is more commonly used to treat open wounds, but Dr Nana Hyldig discussed evidence for the prophylactic use of NPWT for closed incisions to prevent the development of complications, such as infection, wound dehiscence and seroma. If complications related to closed surgical incisions could be prevented, this would reduce some of the burden on community healthcare.

In a systematic review and meta-analysis, which included seven published and three unpublished studies, patients had undergone different surgeries and were treated with various NPWT devices for between two and seven days.¹² The analysis showed that compared with standard postoperative dressings, NPWT significantly reduced the rate of wound infection and seroma when applied to closed surgical wounds. The risk of wound infection was reduced by 46% and risk of seroma by 52% albeit in a heterogeneous population.

Experts believe that patients who are at high risk of complications might stand to gain the most benefit from prophylactic NPWT use. The recently published consensus on the management of closed surgical incisions by the World Union of Wound Healing Societies recommends the use of NPWT in patients who are at high risk for SSIs or who have high consequences of an SSI.¹⁴ Risk factors include a high body mass index, diabetes and long duration of surgery.

To investigate the principle of managing patient by risk, Dr Hyldig and her team are carrying out the Happy Belly study, which is a large randomised trial on the use of prophylactic NPWT in obese women after caesarian section. Preliminary results suggest a 62% reduction in SSI with NPWT compared with standard dressings.¹⁵

A retrospective comparison of the performance of two NPWT systems

Do NPWT systems differ with respect to how well they promote healing? Dr Jenny Smith co-authored a case series study of over 1000 patients to compare the vacuum-assisted closure (VAC^TM) therapy system with the RENASYS^◊ NPWT system.¹⁶ They found no difference between the two NPWT systems in terms of the percentage of patients reaching their predetermined treatment goal, overall reduction in wound area and weekly percentage reduction in wound area.

This study adds to the body of evidence that suggests there are no major differences in clinical efficacy between NPWT devices. Other studies have compared different NPWT devices and foam versus gauze
fillers.^17–19 A randomised study is ongoing to compare single-use versus traditional NPWT investigating percentage change in target ulcer area over 12 weeks in patients with venous LUs or DFUs.²⁰ Results are expected in 2017.

Choice of device can therefore be made on factors other than efficacy. These can include:

• Usability
• Price
• Availability
• Wear time
• Patient and clinician preference
• Capabilities of different devices.

The art of healing stalled wounds with PICO^◊ single-use NPWT system

PICO^◊ is the first single-use, canister-free NPWT system and offers an alternative to the traditional NPWT system. Its size and portability offer benefits in terms of usability and patient preference. Dr Sunitha Nair has used the PICO^◊ system extensively in her wound clinic for many aetiologies, commonly including ulcers (DFU, pressure and venous) and surgical dehiscence. She described several categories of patients eligible for NPWT who she believes would benefit from the choice of PICO^◊ over a traditional system:

• Unable or unwilling to use a conventional machine for social/personal reasons 
• Wound is small/partial thickness 
• Able to transition from traditional NPWT to a single-use device 
• Wound management is palliative so fewer dressing changes are preferred.

From her extensive use of PICO^◊ in the clinic, Dr Nair concluded that it is her belief that the system is unique in that it delivers benefit outside the wound bed. Patients prefer it to the canister-based systems because it is discrete – the pump is small enough to conceal in a pocket.

‘PICO^◊ is the only one that’s helping the neighbourhood’ Dr Sunitha Nair

 

What is the optimal duration of treatment?

Over the last six years Dr Marino Ciliberti’s team has treated more than 1150 patients with NPWT. Visually they saw the greatest impact of NPWT on the wound bed during the first two or three weeks of treatment. Beyond that time there was no difference in the speed of healing if the wounds were treated with NPWT or other types of dressing. To investigate further, they performed wound-edge biopsies to study histological progression. Most patients were treated for three weeks, with biopsies taken each week. Results showed high levels of cellular proliferation over the first two weeks (Figure 3B/3C) followed by increased collagen type 1 production as a precursor to scar tissue by week three (Figure 3D). Therefore, NPWT has its greatest impact during the first three weeks.²¹

What are the economic implications of NPWT?

Dr Ciliberti estimated costs for NPWT as €2025 for four weeks of treatment given in the home.²¹ Even though the dressing costs are higher with NPWT (€1120 versus €96), the overall cost is €596 less than eight weeks of traditional dressings because far less nursing time is required (12 hours versus 48 hours). NPWT would cost €70 more than six weeks of treatment with modern dressings. Importantly, patients treated with NPWT would be healed two weeks earlier than with modern dressings, and four weeks earlier than with traditional dressings.

Q&A Does PICO◊ promote healing in split skin grafts? Yes, it can be very effective in these patients because it boosts microcirculation. When should wound fillers be used in combination with PICO◊? A filler is required if PICO◊ will not have good contact with the base of the wound. Avoid using any filler that will turn into a gel. How far should you border the wound with a PICO◊ dressing? Based on personal experience, the panel recommended using a dressing one size larger than the wound, but this needs to be investigated in a study. Has PICO◊ been used in patients with peripheral arterial disease (ie ABPI <0.5)? These patients would be excluded from any randomised trials so there is no trial evidence. The panel agreed that NPWT would not be appropriate in patients with critical limb ischaemia. What is the optimal duration of PICO◊? The panel all commented that patients are reluctant to stop using the system until the wound has fully healed. This poses a dilemma if PICO◊ was intended only to kick-start a stalled wound.

Developing clinically and financially effective pathways

Role of risk factors in predicting outcomes

Response to NPWT varies between wounds and patients. Dr Caroline Dowsett emphasised how important it is to establish treatment goals and set realistic expectations for the patient. From published literature and clinical experience, can we predict which patients will respond well to NPWT? A recent retrospective analysis of patients treated with NPWT revealed a pattern of poor response in pressure ulcers, staphylococci infection and peripheral artery disease.²² Therefore, we should assess peripheral arterial circulation and treat signs of infection prior to initiating NPWT. Be aware that outcome can also be impaired by patient factors, such as daily bathing, or poor technique, such as failure to prepare the wound bed.

Treatment pathways can be useful when deciding when to use NPWT. Progress during the pathway should be monitored regularly against agreed criteria. It is important to measure outcome and cost benefits to support the business case for its use.

Kick-starting stalled wounds with single-use NPWT

Jane Hampton presented data from a pilot study of nine patients with hard-to-heal LUs or pressure ulcers who were treated with PICO^◊ for two weeks.²³ PICO^◊ effectively kick-started these stalled wounds leading to an average weekly reduction in wound size of 21% (range 7–31%). The wounds healed faster, and reached wound sizes an average of 10 weeks earlier than predicted. Frequency of dressing changes fell from four times weekly at baseline to two times a week with NPWT and 1.8 times a week after NPWT stopped. Weekly cost of treatment with NPWT was 1.6 times higher than at baseline, but fell to three times less when NPWT stopped owing to the reduction in dressing changes. Therefore, additional NPWT costs can be rapidly offset by faster healing and a shortened time period. The results of this study raise some interesting questions.

Important unanswered questions 

• Can these results be repeated?
• Do some wounds respond better to NPWT than others?
• When, during a treatment episode, should NPWT be considered?
• Is it effective to use NPWT more than once during a treatment episode?
• Which decision-making considerations are important?
• Are there clinical/financial advantages if NPWT is used for more than two weeks?

A follow-up study is ongoing that has enrolled 32 patients to date. Patients are treated according to the Kick-Start Pathway in which the decision to continue PICO^◊ is based on response by wound area reduction at weeks 2, 3 and 4: stopped in good responders (>40% wound area reduction) or non-responders (<10%); based on clinical and economic judgement in moderate responders (10–40% change). Final results have not yet been published. However, preliminary data support the previously demonstrated positive benefits of PICO^◊ with a good outcome in a number of previously stalled wounds.²⁴

Cost efficiency of PICO^◊ used for stalled wound

An economic analysis was also performed on this preliminary dataset to investigate the cost of PICO^◊ and the results were presented by Dave Myers. Costs of dressings and nursing time were analysed for the wounds following the PICO^◊ pathway, and this was compared to projected costs if the wounds had remained on standard care. Dressing costs were calculated based on the UK drug tariff with an estimated time of 31 minutes per dressing change, equivalent to £34.62 of nursing time. Costs were calculated for each week that the wound was considered unhealed and projected to week 26. Data suggest that PICO^◊ may offer substantial savings over standard care due to a reduction in nursing time associated with improved projected healing outcomes.²⁵

Q&A What is the financial impact of using NPWT earlier in the treatment pathway? Cost savings could be even higher if we were able to recognise non-healing wounds earlier.

 

Summary

• Challenging wounds cause a considerable burden to patients and a large economic cost to society
• Most of the cost of care lies with community nurses in the time that it takes for regular redressing of wounds 
• Advanced wound care systems, such as NPWT, can improve patient outcomes
• NPWT has its greatest impact during the first three weeks and can be used to kick-start stalled wounds
• Additional unit costs of NPWT over standard dressings can be rapidly offset by faster healing and a shortened time period
• Patients often prefer single-use NPWT systems to traditional NPWT because they are more portable and discrete

References

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