Published online: 25 August 2026

Future Research and Clinical Questions

Suggested citation

National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Future Research and Clinical Questions. In: Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline: Fourth Edition. Emily Haesler (Ed.). 2026. [cited: download date]. Available from: https://internationalguideline.com.

Introduction

The guideline development, recommendations and good practice statements are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. This is considered the current state-of-the-art method to develop trustworthy clinical practice guidelines (1, 2). GRADE focuses on clinical evidence and its relationship to clinical outcomes.

Core outcome sets

In this edition of the guideline, the primary outcome used to evaluate interventions designed to prevent pressure injuries (PIs) is PI occurrence. This outcome has been identified as critically important in a previously published core outcome set for PI prevention that was based on comprehensive reviews, service user input, a Delphi survey of various key stakeholders, and a consensus meeting (3). A core set of outcomes has not been developed for pressure injury treatment. The outcomes used to evaluate PI treatments in this guideline were those identified as critically important based on a review of the literature (4, 5, 6, 7, 8, 9, 10, 11). The outcomes were time to PI healing, complete healing, percent change in wound size, PI-related pain and, if wound infection was diagnosed at baseline, changes in signs and symptoms of infection. Additionally, the final selection of outcomes was influenced by a consumer survey of over 800 individuals in 46 countries including individuals with or at risk of pressure injuries, their carers, clinical experts, researchers, educators and industry stakeholders. These individuals rated the importance of various prevention and treatment outcomes and prioritized the importance of interventions used to achieve those outcomes.

The Guideline Governance Group acknowledges that the PI research reports many outcomes beyond those considered critically important in the GRADE approach taken for this guideline. For example, over 35 outcomes were identified for voting  in the Delphi study conducted to develop the core outcome set for PI prevention trials (3).  In our own scoping on outcomes for PI treatment, a wide variety of wound healing outcomes were identified (e.g., changes in tissue type, changes of score on specific wound assessment tools, etc). Additionally, a large body of research reports intermediary outcomes (e.g., device-skin interface pressure, physiological changes such as inflammatory markers, etc.).

The Guideline Governance Group encourage researchers conducting clinical trials related to preventing pressure injuries to include outcomes from the core outcome set(3) in their methods and reporting because this approach increases the consistency in how research is conducted thereby enhancing the ability to evaluate the body of research (12).

Types of evidence

There is an urgent need for well-designed clinical trials to generate high quality evidence on PI prevention and treatment (13). When current state-of-the-art guideline development methods are applied to selection, appraisal and analysis of the body of evidence on PI prevention and treatment, the paucity of well-designed clinical research is a significant factor in the lack of strong recommendations and the low certainty of evidence supporting conditional recommendations included in this edition of the guideline (14). However, the Guideline Governance Group acknowledges the challenges around designing and conducting clinical research in this field.

The Guideline Governance Group acknowledges that in addition to clinical research, there are other important approaches for knowledge generation, including laboratory research, animal research and finite element, computer or logic modelling (15, 16). Every approach has its own strengths and limitations and there is currently no established method to appraise and integrate all these different types of research into clinical guideline development.(16) In addition, models based on finite assumptions cannot replace clinical research, which takes the full complexity of human biology and behaviour into account (15). These other forms of research are extremely important to inform theory, product development and ultimately clinical interventions, although, in general, the type of data does not lend itself  to evaluation using the current GRADE methods. The Guideline Governance Group agrees that there is an immediate demand to develop well thought out and transparent ways to integrate a far wider range of evidence in future clinical practice guideline development (17, 18).

In this section of the guideline, the Guideline Governance Group have identified areas of priority for future research. This includes gaps in the research (or core outcome reporting) addressing some of the clinical questions that were planned for this guideline, areas in which there is a paucity of well-designed studies, areas where basic science can inform and stimulate the development of new clinical interventions for clinical testing of their effects on patient outcomes, and areas where there is an urgent need to address the needs of specific populations (e.g., pediatrics, individuals with spinal cord injury, etc.)

Nutrition

The evidence available to address all the clinical questions on nutrition was generally of low or very low certainty. The Guideline Governance Group noted the following gaps in the evidence addressing the topics in this section that require future research:

  • There is an overall paucity of research on resource requirements, cost-effectiveness and feasibility of the interventions focused on nutrition strategies.

  • There is an overall paucity of research focussed on nutrition strategies and regimens that include patient reported outcome measures (PROMs, e.g., satisfaction with diet etc.) or that are co-designed with consumers.

  • There is a paucity of evidence on effectiveness of many interventions for neonates and children. This is considered a significant gap in the research (19 ,20).

The Guideline Governance Group noted that nutrition is a complex topic that requires consideration of the individual’s complex clinical needs beyond pressure injury prevention. Nutritional interventions are complicated by the generally multi-component interventions that reduced confidence that any single specific nutrition supplement is associated with reducing PI occurrence.  Implementation research could explore:

  • What strategies are effective in promoting engagement of the individual and their informal carer in nutrition interventions?

  • Should individualized nutrition interventions be included in a PI prevention bundle?

Repositioning and Mobilization

The evidence available to address all the clinical questions on repositioning was generally of low or very low certainty. There is an ongoing need for more research on repositioning frequency and strategies for repositioning to increase the confidence in making recommendations on the topics included above. The Guideline Governance Group noted the following gaps in the evidence that require future research:

  • The body of evidence includes minimal reporting of undesirable effects associated repositioning strategies and regimens.

  • There is an overall paucity of research on resource requirements, cost-effectiveness and feasibility of the interventions focussed on repositioning strategies and regimens.

  • There is an overall paucity of research focussed on repositioning strategies and regimens that include patient reported outcome measures (PROMs, e.g., sleep quality, comfort, etc.) or that are co-designed with consumers.

  • Research is needed to evaluate repositioning frequencies in combination with different pressure reducing support surfaces (e.g., active versus reactive support surfaces with repositioning).

  • There is a paucity of evidence on effectiveness of many interventions for, and the experiences of, individuals in home settings, neonates and children, and individuals with spinal cord injury or disability that reduces mobility.

The Guideline Governance Group noted the following future clinical questions for potential/future address:

  • Should an automated repositioning device (e.g., lateral tilt device) versus manual repositioning be used to prevent PI occurrence in individuals at risk?

  • Should a repositioning turn system versus not using a turn system be used to prevent PI occurrence in individuals at risk?

  • Are some consumer education programs more effective than others in improving consumer engagement in PI prevention, including repositioning?

  • Do longer intervals between repositioning at night improve quality of sleep without increasing incidence of pressure injury?

  • Should an interface mapping system versus no interface mapping system be used to inform repositioning frequency or evaluate effectiveness of repositioning? This research should include the  mechanisms of actions of sensor systems and a sufficient description of the prevention protocol that was implemented to action the sensor system information output.

The Guideline Governance Group noted the following areas for future research:

  • Effectiveness and implementation of sensor systems used in home care environments as prompts for repositioning for individuals and/or their informal caregivers (21). Preliminary work has explored the feasibility of using non-contact sensors, but did not evaluate effectiveness in promoting implementation of repositioning regimens or prevention of PIs.

  • Movement sensors have been used to evaluate the frequency with which individuals independently move in transient ways (i.e. smaller and less obvious movement while maintaining the same overall positioning)(4). Further research on the impact of transient movement in reducing PI occurrence and consideration in PI prevention programs is required.

Full Body Support Surfaces

The evidence available to address all the clinical questions on support surfaces was generally of low or very low certainty. This was primarily because the studies were at high risk of bias due to challenges designing blinded studies without confounding factors and with sufficiently large populations. It has been clearly established that a support surface with pressure redistribution properties is a minimal standard in preventing pressure injuries, and in most clinical settings the default support surface is a pressure redistribution foam (reactive) full body support surface. However, in community settings and some geographic areas access to a pressure redistribution foam (reactive) full body support surface remains a challenge. The Guideline Governance Group noted the following gaps in the evidence that require future research:

  • For many of the clinical questions there were no recent comparative trials. This means that the support surfaces considered in the analyses were for products that may not still be in clinical use and/or that have been superseded by newer models and designs.

  • The body of evidence includes minimal reporting of undesirable effects associated with any specific type of full body support surfaces.

  • There were no comparative studies to include for clinical questions comparing:

    • air fluidized support surfaces to any other support surface for preventing PIs;  

    • air-filled surfaces (reactive) to pressure-redistribution foam surfaces for treating PIs; or

    • air fluidized support surface to alternating pressure support surface for treating PIs.

  • There is an overall paucity of research on resource requirements, cost-effectiveness and feasibility of different full body support surfaces; however, it is acknowledged that these factors are likely to vary widely across different clinical and geographic settings.

  • ‍There is an overall paucity of research that is co-designed with consumers or that focusses on patient reported outcome measures (PROMs, e.g., sleep quality, comfort, etc.) associated with different full body support surfaces.

  • ‍There is a paucity of evidence on effectiveness of different full body support surfaces, and the experiences of, individuals in home settings and neonates and children.

‍ ‍The Guideline Governance Group noted the following future clinical questions for potential/future address in the guideline:

  • What are the most effective full body support surfaces for reducing PI occurrence in neonates/children at risk?

  • How effective is implementation of an algorithm for selecting a full body support surface for reducing PI occurrence in individual at risk?

Seating Surfaces

The evidence available to address the clinical question on whether a pressure redistribution seated support surface is clinically effective versus no pressure redistribution seated support surface was of moderate quality, representing an area in pressure injury prevention that has some of the most robust research. This evidence clarifies the undisputed role that seated support surfaces with pressure distribution and shear reduction characteristics play in preventing PIs. More research comparing use of a specialized seating support surface to no specialized seating support surface is not required.

The Guideline Governance Group noted the following gaps in the evidence addressing the topics in this section that require future research:

  • The body of evidence includes minimal reporting of undesirable effects associated with any specific seating support surfaces.

  • There is an overall paucity of research on resource requirements, cost-effectiveness and feasibility of different seating support surfaces and chairs/wheelchairs; however, it is acknowledged that these factors are likely to vary widely across different clinical and geographic settings.

  • There is very limited research on effective seating regimens, especially related to time-limited sitting out of bed. More research on the relative benefits and risks of limiting the time an individual spends seated in a chair/wheelchair is required.

  • There is an overall paucity of research that is co-designed with consumers or that focusses on patient reported outcome measures (PROMs, e.g., comfort, ability to continue to perform activities of daily living etc.) associated with different seating support surfaces or chairs/wheelchairs.

  • There is an overall paucity of evidence comparing different types of specialized seating support surfaces (23).

The Guideline Governance Group noted there was no comparative evidence on following clinical questions:

  • Should tilt-in-space (dynamic) seating versus non-dynamic seating be used to prevent pressure injury occurrence in individuals at risk who are seated? 

  • Should more frequent repositioning versus less frequent repositioning be used to prevent PI occurrence in individuals at risk who are seated?

  • Should large body movements versus small body movements (micromovements) be used to prevent pressure injury occurrence in individuals at risk who are seated?

Preventive Skin Care

.The evidence available to address all the clinical questions on preventive skin care was generally of low or very low certainty. This was primarily because the studies were at high risk of bias due to challenges designing blinded studies without confounding factors and with sufficiently large populations. The Guideline Governance Group noted the following gaps in the evidence that require future research:

  • There is only limited evidence (24, 25) on the effectiveness of preventive dressings used at anatomical locations other than the heel or the sacrum. Further research on use of preventive dressings to protect pressure points in prone position and other bony prominences (e.g., elbows) is warranted.

  • There is limited evidence on the effectiveness of preventive dressings in some specific population groups (including but not limited to individuals at the end of life, individuals with spinal cord injury and individuals with dark skin tones). Exploration of the role preventive dressings can play in the care trajectory of these individuals would be beneficial.

  • There is limited evidence on the effectiveness and cost-effectiveness of preventive dressings used longer durations, including clinical studies that extend on the current bench science (26, 27, 28) by exploring the duration of time/clinical conditions requiring replacement of a preventive dressing or the incorporation of preventive dressings into PI prevention plans over longer durations (e.g., more than six to eight weeks).

  • There is limited recent evidence on the effectiveness of low friction fabrics, including their use in conjunction with topical skin products (e.g., moisturizers) and preventive dressings. More exploration of the potential benefits and risks and the incorporation of low friction fabrics into care pathways is required.

  • There is an overall paucity of research that is co-designed with consumers or that focusses on patient reported outcome measures (PROMs, e.g., comfort, etc.) associated with different preventive skin care interventions.

  • There is a paucity of evidence on effectiveness of different preventive skin care interventions for neonates and children.

  • There is limited evidence on the effectiveness of leave-on topical products based on empirically and/or theoretically well justified mechanisms of action regarding prevention of PIs. Explanative proof-of-concept studies are warranted.

The Guideline Governance Group noted there was no comparative evidence to address the following clinical questions:

  • The effectiveness of a hydrocolloid dressing used for preventing PIs (not device-related) versus no preventive dressing.

  • The effectiveness of a multilayered soft silicone foam dressing versus any other preventive dressing for anatomical locations other than the heel and sacrum.

The Guideline Governance Group noted difficulties in evaluating the evidence related to leave-on topical skin products. There are wide discrepancies in the ways products are described and classified, and there is no strong evidence on the mechanism by which a leave-on topical skin product prevents PIs. Future research is required to attain clarity regarding the mechanisms by which oil-based products prevent PI. A transparent product classification system is also needed, as well as well-conducted clinical studies using clinically relevant head-to-head comparisons of major and widespread topical products.

Heel Pressure Injuries

The evidence available to address the clinical questions on preventing heel PIs was generally of low or very low certainty. This was primarily because the studies were at high risk of bias due to challenges designing blinded studies without confounding factors and with sufficiently large populations. The Guideline Governance Group did not identify comparative studies that provided evidence on the following clinical questions for preventing heel PIs

  • Convoluted foam cushion versus any other heel offloading cushion/device,

  • Medical grade sheepskin versus any other heel offloading cushion/device,

  • Polyfiber cushion versus any other heel offloading cushion/device, or

  • Any preventive dressing compared to a heel offloading device.

The Guideline Governance Group noted gaps in the evidence addressing the topics in this section that require future research:

  • There was limited information about potential undesirable effects associated with techniques to reduce the risk of a heel PI.

  • Establishing mechanisms by which leave-on topical products could influence PI development on the heels (29).

  • There is limited evidence on the effectiveness of preventive dressings in some specific population groups, including but not limited to individuals at the end of life, individuals with spinal cord injury, and individuals with dark skin tones. Exploration of the role preventive dressings can play in the care trajectory of these individuals would be beneficial.

  • There is limited evidence on the effectiveness of heel offloading strategies in individuals for whom heel offloading is often challenging, including those with agitation or cognitive impairment.

  • There is an overall paucity of research that is co-designed with consumers or that focuses on patient reported outcome measures (PROMs, e.g., comfort) associated with different preventive skin care interventions.

Device Related Pressure Injuries

The evidence available to address most clinical questions on preventing DRPIs was of very low certainty. This was primarily because the studies were at high risk of bias due to challenges designing blinded studies without confounding factors and with sufficiently large populations. The Guideline Governance Group noted the following gaps in the evidence addressing the topics in this section that require future research:

  • There is an overall paucity of research that is co-designed with consumers or that focuses on patient reported outcome measures (PROMs, e.g., comfort, etc.) associated with medical device use. Given that many individuals use medical devices over the long term, research that includes this perspective would be of particular value. 

  • There is a paucity of evidence on effectiveness of different strategies to prevent DRPIs in neonates and children. Given that the pediatric population experiences the highest incidence of DRPIs, exploration of strategies in this group is of particular importance.

  • There is limited evidence on the effectiveness of leave-on topical products (e.g. moisturizers) based on prespecified mechanisms of action regarding prevention of DRPIs. Given that leave-on topical products are commonly used under and around medical devices, explanative proof-of-concept studies and effectiveness studies are warranted.

The Guideline Governance Group noted there was no comparative evidence to address the following clinical questions:

  • The effectiveness of a naso-tracheal tube fixation device versus no naso-tracheal tube fixation device.

  • The effectiveness of a repositioning medical device versus no device repositioning.

  • The effectiveness of alternating the type of oxygen delivery device versus not altering the type of oxygen delivery device.

  • The effectiveness of a pressure redistributing respiratory device versus a standard respiratory device.

Skin and Tissue Assessment

The Guideline Governance Group noted that non-invasive methods to assess perfusion (and oxygenation), particularly photoplethysmogram (PPG), laser Doppler flowmetry (LDF) (30, 31) Near-Infrared Spectroscopy (NIRS) and transcutaneous oxygen measurements are becoming increasingly popular as devices become more accessible in clinical practice. However, there is limited evidence available on their use in skin and tissue assessment for early signs of damage associated with pressure (31).  Laser Doppler flowmetry, and photoplethysmography both provide non-invasive methods to assess vascular circulation at different tissue depths (32). Transcutaneous oxygen monitoring provides an indication of the oxygen perfused to tissues (33) and NIRS provides a measure of tissue oxygen saturation (StO2) (34, 35, 36).  Although measurement of the flow of blood and distribution of oxygen can provide an indication of tissue health, the current body of evidence does not fully demonstrate that these assessment techniques have utility as bedside techniques to enhance the early identification of damage in individuals at risk of PIs (31).  Future research on these assessment techniques should focus on establishing the sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operator curve (AUROC) of these clinical tests in identifying changes associated with early tissue damage.  Additionally, clinical studies should be conducted that demonstrate that these techniques both enhance clinical reasoning and interventions which can lead to a reduction in PI occurrence.

The Guideline Governance Group noted the small body of evidence evaluating the role of biophysical strategies to measure skin hydration (i.e. the level of moisture content in the epidermis rather than sub-epidermal measurements) as an indicator of early tissue damage (37, 38). The body of evidence suggests there may be a relationship between both lower and higher epidermal skin hydration and PI development (37) and that the measurement of epidermal skin hydration may be reliable across different anatomical locations (38). Future research should focus on the role of skin hydration in PI development, the diagnostic accuracy of methods to measure epidermal skin hydration and the feasibility and utility of its measurement in clinical practice, as distinct from the measurement of sub-epidermal hydration.

The Guideline Governance Group noted the small body of evidence exploring ultrasound for diagnostic purposes. Ultrasound is an acoustic pulsed wave in which mechanical vibration is transmitted in a wave formation at frequencies beyond the upper limit of human hearing to detect objects and measure distances. Several studies have suggested that ultrasound techniques may be useful to detect abnormal tissues, including identification of edematous tissue under intact skin (31, 39, 40, 41, 42). However, there is limited evidence and the current studies have not validated ultrasound technique against magnetic resonance imaging (MRI), the gold standard method of tissue deformation measurement. Further work is required to determine how ultrasound findings correlate with various stages of pressure injuries (40). Future research should also focus on determining the reliability and validity (43), as well as the feasibility and utility of ultrasound for bedside assessment of PIs.

from local from systemic inflammation is warranted, including its reliability and validity and practical implementation in clinical settings (45).

The Guideline Governance Group noted gaps in evidence in certain specific populations. More research is required on assessable changes in skin and tissue associated with pressure damage in individuals with medium and dark skin tones, neonate and child populations and use of different assessment techniques in operating room/procedural settings.

Future research

Overall, technological advancements are urgently needed to improve skin and tissue assessment and pressure injury prevention in the future.  There is an urgent need to further explore the test properties of technologies that enhance skin and tissue assessment. This research should apply established testing standards when relevant. Studies are required that explore the testing properties and diagnostic accuracy of both devices to measure focal edema and thermography devices, and identification of sub-populations for whom testing achieves the greatest benefits is an imperative given the resources requirements.

Studies that provide evidence on the use of advanced technology to increase/enhance PI preventive care, and establish the link to a reduction in PI occurrence are an imperative. There is also a need for research exploring protocols for integration of assessment findings using advanced technology into clinical pathways across different clinical settings, including the impact on staff work flow, resource allocation and other implementation barriers that are emerging in the evidence (46, 47). Realistic cost-benefit analyses and implementation studies exploring feasibility of device adoption in a variety of settings is urgently required.

Additionally, in pediatric populations only one small study explored measurement of focal edema, and no studies explored the role of infrared thermography. Reliability, validity, feasibility and acceptability of advanced technology for skin and tissue assessment should be explored in pediatric settings.

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