Utilizing International Consensus Panel Recommendations and a Clinical Decision Tree to Guide Selection of Negative Pressure Wound Therapy

Acute and chronic wounds create a substantial burden for patients, providers, and health care systems. In the United States in 2014, approximately 8.2 million people (roughly 15% of the Medicare population) suffered from chronic wounds.¹ Treatment of these wounds carried an estimated annual cost of between $28.1 billion and $96.8 billion to the US health care system.¹ In Canada, 50% of nursing visits in the community setting involve wound care delivery, and 35% of persons receiving community care have a chronic wound.^2,3 Because of this, Canadian provinces developed focused initiatives to improve patient outcomes, reduce hospitalizations and readmissions, and cut health care costs related to wounds. It has been estimated that adoption of these best practices could reduce Canadian community wound care costs by up to 50%.⁴

Ensuring that advanced wound therapies are utilized appropriately can improve patient outcomes and decrease health care expenditures. In the time since NPWT became commercially available in the late 20th century, it has been embraced by the medical community as a standard treatment modality for complex wounds. NPWT was initially prescribed by clinicians for the management of large, complex wounds with high levels of exudate.⁵ However, a developing understanding of the multimodal mechanism of action of NPWT has expanded its application to address a range of acute and chronic wound types, regardless of their size or level of exudate.⁶

Two main categories of NPWT exist: tNPWT and sNPWT. The original systems, now categorized as tNPWT, utilize a non-disposable pump that delivers subatmospheric pressure to the wound bed. This is accomplished by the creation of an airtight seal on the periwound area with a clear, adhesive drape. Negative pressure is delivered via tubing from the pump to the wound bed through a wound filler, typically gauze or foam, and a disposable canister collects exudate from the wound. It is understood that a wide range of pressure settings deliver therapeutic outcomes, and tNPWT pumps typically provide a range of therapy modes, therapy set points, and cycle times that allow individualized care of wounds and patients.⁷ sNPWT emerged on the market in the early 2000s and applies subatmospheric pressure to the wound through a smaller and more portable single-use pump. Various sNPWT systems are now commercially available and may function with or without an associated canister and integrated dressing.

In response to the numerous NPWT product options that now exist, the need arose for expert guidance on the appropriate product use to optimize clinical, economic, and logistical outcomes, as well as patient experience. In 2020, an international consensus panel of 8 experts from Canada, Spain, the United Kingdom, and the United States convened virtually with the aim of establishing a consensus on how and when to use NPWT, as well as when to transition between tNPWT and sNPWT devices.⁷ Ten Consensus Statements (Table 1) were agreed upon by the panel in the following categories: therapeutic goals, wound-related factors, patient satisfaction and quality of life, care setting-related factors, economic-related factors, and NPWT system-related factors. 

In addition, the consensus panel created a clinical decision tree to guide the selection of tNPWT and/or sNPWT (Figure 1). Both tNPWT and sNPWT operate with unique characteristics and the consensus panel recommendations, along with the clinical decision tree, guide clinicians to utilize the most appropriate therapy type. 

The Consensus Statements and clinical decision tree for open wounds were used as guidance for clinicians using a single-provider NPWT portfolio and prescribing care to patients. Two non-disposable traditional negative pressure pumps (RENASYS TOUCH tNPWT and RENASYS GO tNPWT, Smith and Nephew) and a small, sNPWT device (PICO sNPWT, Smith and Nephew) that is intended for use on low to moderately exuding open wounds and closed surgical incisions were accessible.⁸ The aim of the current work is to demonstrate the applicability of the consensus panel recommendations and clinical decision tree for sNPWT and tNPWT, thereby showing the resultant impact on routine clinical practice. 

The first and second authors of the current study elected to explore the benefits of applying the consensus panel recommendations and clinical decision tree into their routine wound management practice. Bayshore HealthCare is one of the leading providers of home and community health care in Canada, serving over 350 000 clients. In Western Pennsylvania, AHN provides a range of services through 14 hospitals and more than 200 primary and specialty-care practices.

Informed consent was obtained from the patients, as per local hospital procedures, to capture the case study of their wound treatment, including non-identifiable photographs of their wounds. No identifiable patient information was included in the cases. As standard of care was not changed and the devices being utilized are approved for use in both Canada and the United States, there was not a requirement to seek institutional ethics board approval. The outcomes reported were extracted from the patients’ medical notes by the treating clinicians during routine wound management treatment and until the wound treatment goals were achieved. 

Hurd et al⁷ developed 10 Consensus Statements and a clinical decision tree to inform the optimization of NPWT in acute and chronic wound management. The case studies described within this article demonstrate the clinical applicability of the Consensus Statements, outlined in Table 1.⁷ 

Case 1 addressed Consensus Statements 1-5 (Figure 2). This patient presented to an acute care hospital with a dorsal foot abscess resulting from type 2 diabetes. The patient underwent surgical debridement, resulting in a full-thickness wound with exposed tendon. Following the surgical intervention, Consensus Statement 1 guided the choice to treat the wound with NPWT aligned with the well-established therapeutic treatment goals of NPWT. According to a recent comprehensive review of NPWT, therapeutic goals may be either short-term or long-term.⁹ Short-term goals may focus on achieving wound stabilization through the management of wound exudate, odor, pain, or the prevention of infection.⁷ Long-term goals include considerations such as the reduction in wound size, reduction in the amount of wound exudate, development of healthy granulation tissue, or preparation of the wound bed for closure with a skin graft or flap.⁷ A review of Consensus Statements 2 and 3 and the clinical decision tree indicated that tNPWT was the appropriate therapy choice due to the wound dimensions and anticipated level of exudate. tNPWT with a nonadherent contact layer facilitated granulation over the exposed tendon and reduced the wound volume, at which point the patient returned to the operating room and the wound was covered with a full-thickness skin graft. At the time of grafting, the transition to sNPWT was made in accordance with Consensus Statements 4 and 5. NPWT dressings have been found to be beneficial in facilitating intimate contact between the wound bed and graft by helping to bolster, minimize friction and sheer, and reduce exudate accumulation between the wound bed and graft.⁷ Skin substitutes involve similar principles for application.¹⁰ Due to the characteristics of a wound after graft or skin substitute placement, sNPWT is an appropriate therapy choice. Following the application of a graft or skin substitute, wounds are typically shallow and anticipated to exhibit low to moderate exudate.¹¹ Some sNPWT devices include an integrated dressing with silicone adhesive, which may help reduce tissue trauma during dressing removal.¹² Additionally, the recommendation is that the bolster dressing should remain in place for approximately 7 days, which is well suited for the 7-day wear time of many sNPWT dressings.¹¹ The wound then exhibited a size and level of exudate amenable to sNPWT, and the system was applied to bolster the full-thickness skin graft. sNPWT was utilized for 7 days postoperatively, and it was noted that the patient benefited from the improved mobility enabled by a smaller device. 

Consensus Statements 6 and 7 address the important aspects of patient satisfaction and quality of life. In addition to the clinical examination of the wound, patient factors should also be considered when selecting the NPWT device to be used. Janssen and colleagues evaluated the determinants for adherence to NPWT and found that 38% of patients elected to cease NPWT in advance of the clinician’s wishes.¹³ Of those that ceased therapy, 53% cited the cause to be the limitation the therapy placed on their activities of daily living.¹³ There is evidence that clinical outcomes across tNPWT devices are similar in comparative studies.⁷ For this reason, Consensus Statements 6 and 7 reflect that sNPWT should be considered as first-line therapy when appropriate, as this may minimize the impact on activities of daily living during therapy. 

To demonstrate this, Case 2 involved an open wound present in total for more than 6 years (Figure 3). At initial presentation a small wound was noted on the right anterior lower leg. One year later, the wound wrapped circumferentially around the right lower leg and exhibited large amounts of necrotic tissue and exudate. The patient’s pain was not managed, to the extent that it had been necessary for the patient to resign from their job. A complex diagnosis was made of anti-neutrophil cytoplasmic autoantibody vasculitis with pyoderma gangrenosum. The clinician applied the principles of Consensus Statements 2, 3, 5, 6, and 7. Once the patient’s pain was managed and the wound characteristics deemed appropriate for initiation of NPWT, tNPWT was applied in conjunction with a multilayer compression bandage system. The wound progressed over the first 3 weeks of treatment, and at reassessment the clinician again followed the Consensus Statements and clinical decision tree. The wound was deemed clinically appropriate for transition to sNPWT, aiming to both improve patient comfort and increase their ability to independently perform activities of daily living. Once the wound had met the treatment goals of NPWT, the clinician discontinued NPWT and transitioned to conventional dressings.

Consensus Statements 8 and 9 address the role of NPWT in the transition of the patient between varying levels and sites of care. Based on the characteristics of the wound, many wounds may be eligible for sNPWT as the initial treatment option. If not, wounds should be re-evaluated for transition from tNPWT to sNPWT when appropriate to improve discharge logistics, speed, patient throughput, and increase inpatient bed availability. 

Case 3 demonstrated the application of Consensus Statements 8 and 9 (Figure 4). For patients undergoing grafting, a common practice is the application of tNPWT and immobilization for up to 5 days in the inpatient setting. AHN observed an improvement in economic and logistical efficiencies by altering this practice to include sNPWT over the skin graft or flap. 

This change in practice allowed AHN to reduce hospital length of stay by transforming usual 5-day hospitalizations into 23-hour observation visits after surgery. sNPWT provides off-the-shelf availability of NPWT without insurance preapproval or coordination of tNPWT pump delivery in advance of the surgery. Improved efficiencies resulted from reduced tNPWT pump logistics and provided a savings of 4 bed days for this surgical procedure. 

Consensus Statement 10 provides guidance for the system-related factors that should drive institutional decision-making for NPWT manufacturer selection. The COVID-19 pandemic has placed an increased focus on health care spending and logistics.¹⁴ Hospitals worldwide have experienced profound net income losses and an increase in staffing needs.¹⁴ Many individuals are responsible for supporting the delivery of NPWT across various sites of care. This may include hospital supply and logistical staff, wound and non-wound specialists, case managers, durable medical equipment providers, outpatient services, and more. Efficient utilization of an NPWT portfolio presents an opportunity for health care systems to improve logistical and economic efficiencies. 

A multidisciplinary team at AHN applied the principles of Consensus Statement 10 to the evaluation of NPWT suppliers. AHN’s goal was to select and utilize an NPWT supplier in a way that would support their established clinical outcomes (ie, reduction in wound dimensions, time to wound closure, and time to discharge) while offering the opportunity to enhance their economic and logistical efficiencies. A review of the best available evidence for devices and the contribution margin, as well as an evaluation of coding and the contractual costs, was performed. The conversion to a single-provider NPWT portfolio provided AHN a greater than $1 million USD annual cost savings, while continuing to deliver equivalent clinical outcomes. 

Cost consideration may also be evaluated depending upon the therapy type selected, either sNPWT or tNPWT. One retrospective cost-minimization analysis of Medicare-paid claims for several wound types identified significant economic benefit when using sNPWT rather than tNPWT.¹⁵

Financial pressures are causing health care entities to think critically about their costs and evaluate all potential value propositions, whether they involve reducing or switching vendors. Through the processes of a value analysis committee, prudent choices can be made to encourage thoughtful expenditure. 

Case 4 demonstrated the comprehensive use of Consensus Statements 1-10 and the clinical decision tree as a patient moves through various sites of care (Figure 5). The patient had undergone an abdominal perineal resection due to a history of ulcerative colitis. In this surgery, the perineal portion of this procedure involves the removal of the distal colon, rectum, and the anal sphincter and is known to have a high complication rate of delayed wound healing (86%), dehiscence (22%), and infection (27%).¹⁶ One year later, following a lengthy hospital stay and prolonged care within the community, a 10-cm tunnel remained that required daily wound care. The patient returned for an elective surgery to reopen the incision, perform wound wash out, and reattempt primary wound closure. It was understood that the risk of dehiscence was high due to the wound location and previous chronicity. As such, sNPWT was applied in the operating room prophylactically, to reduce the risk of surgical site complications, and the patient was discharged.

At the 2-week reassessment, the incision was found to be partially dehisced. Assessing for size and level of exudate, the clinical decision tree was applied and tNPWT selected for use with a saline-moistened antimicrobial gauze to fill tunnels followed by application of a foam filler. Figure 5 illustrates that the conformable and flexible tubing (RENASYS Soft Port, Smith and Nephew) is constructed in such a way that it can reduce the need for bridging, which helped to reduce dressing application time and improve the patient’s comfort.¹⁷ The wound was reevaluated at regular intervals, and when wound depth and exudate were deemed appropriate, the therapy was transitioned again to sNPWT. This transition to sNPWT allowed for increased mobility and ease of dressing changes. Once the wound further reduced in size, NPWT was discontinued and final closure was achieved through an antimicrobial barrier dressing (ACTICOAT Flex 3, Smith and Nephew), with which the patient was able to perform independent dressing changes. Case 4 demonstrated the value of applying the Consensus Statements and clinical decision tree at each wound evaluation.

The cases presented demonstrate the use of the Consensus Statements and clinical decision tree as a part of routine clinical practice. This selection of cases presents examples of both tNPWT and sNPWT being utilized in the treatment of acute and chronic wounds and incisions in the acute and post-acute settings. The cases demonstrate a range of wound types as well as wound and patient factors that may complicate the treatment of wounds. These include but are not limited to risk for complications, discharge logistics, patient quality of life, pain management, activity and mobility, and social factors. The cases demonstrate that the use of clinically endorsed guidance may help with consistency of treatment decisions by considering clinical, economic, and logistical outcomes. Simultaneously, understanding the treatment options available and the features and benefits of their uses allows clinicians to customize the care plan to further support the patient’s experience throughout therapy.

The case reports presented herein are of real-world wound management utilizing NPWT within an acute and community setting. Treatment was not controlled or defined per a study protocol and was carried out in accordance with local standard of care procedures within each treatment facility. Each treating clinician followed their standard protocol for NPWT use and applied published clinician-endorsed guidance as to when a patient would benefit from sNPWT or tNPWT based upon individual patients’ wound characteristics. The cases reported are subject to bias due to the small numbers presented, the interpretation of the clinical decision tree by 2 clinicians, and lack of heterogeneity within the population. However, the objective of this work was to demonstrate the usability of the NPWT Consensus Statements in real-world practice, with demonstration of clinical and economic outcomes. The real-world evidence reported here demonstrates positive proof of concept for both the Consensus Statements and clinical decision tree being actively used within routine wound management.  

A clinician’s primary goal is to provide optimal clinical outcomes to patients. To do so successfully, clinicians must also consider and support the patient’s quality of life and enable efficiencies within their health care system. Hurd et al⁷ convened to review the evidence and develop best practice recommendations to address these topics as relates to NPWT. Additionally, many technical advancements have been made for wound management with NPWT, resulting in a range of therapy delivery options. The consensus panel developed the clinical decision tree to help clinicians apply the most appropriate NPWT device type to patients at the best time and encourage regular wound evaluation for device transition.

The case presentations (summarized in Table 2) serve to illustrate the application of this expert guidance through the use of a single-provider NPWT portfolio. tNPWT and sNPWT were utilized according to the clinical decision tree across various levels of care and care settings, and case reports were developed to document the process. Application of the consensus panel recommendations and clinical decision tree may support clinicians in optimizing the delivery of NPWT.