Protocol for the Development of the Fourth Edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline Using GRADE Methods.

ABSTRACT: The National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel, and the Pan Pacific Pressure Injury Alliance are commencing a new (fourth) edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline . The fourth edition of the International Pressure Injury (PI) Guideline will be developed using GRADE methods to ensure a rigorous process consistent with evolving international standards. Clinical questions will address prevention and treatment of PIs, identification of individuals at risk of PIs, assessment of skin and tissues, and PI assessment. Implementation considerations supporting application of the guidance in clinical practice will be developed. The guideline development process will be overseen by a guideline governance group and methodologist; the guideline development team will include health professionals, educators, researchers, individuals with or at risk of PIs, and informal carers.This article presents the project structure and processes to be used to undertake a systematic literature search, appraise risk of bias of the evidence, and aggregate research findings. The methods detail how certainty of evidence will be evaluated; presentation of relative benefits, risks, feasibility, acceptability, and resource requirements; and how recommendations will be made and graded. The methods outline transparent processes of development that combine scientific research with best clinical practice. Strong involvement from health professionals, educators, individuals with PIs, and informal carers will enhance the guideline's relevance and facilitate uptake. This update builds on previous editions to ensure consistency and comparability, with methodology changes improving the guideline's quality and clarity.

Development, dissemination and evaluation of a smartphone-based app for pressure ulcer/injury prevention and treatment for use at the bedside.

OBJECTIVE: After launching the 2019 International Pressure Ulcer/Injury Guideline, the National Pressure Injury Advisory Panel (NPIAP), the European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA) collaborated with Sensorydata Corp., US, to develop a guideline app (InterPIP App). The app was designed to: present evidence-based guideline recommendations; incorporate search capacities and functionality to facilitate easy access to clinical guidance; provide accessibility in multiple languages; and to be available worldwide at a reasonable price, including opportunities for free access in low-resource countries. This paper describes the development, dissemination and formative evaluation of a mobile app providing evidence-based recommendations for pressure injury prevention, assessment/classification, and treatment at the point of care. METHOD: An evaluation tool was designed based on a framework developed by Nouri et al. and made available to all app subscribers. RESULTS: The InterPIP App is currently available in 11 languages and had been downloaded 3616 times by February 2022 in 78 countries. A total of 62 individuals responded to the survey of end-users. In this formal evaluation of user experiences, the app was rated positively on criteria of: information/content; usability; design; functionality; ethics; and security/privacy (median=4 on a 1-5 Likert scale). Overall perceived value was ranked lower with a median of three. Users provided suggestions for ongoing app enhancement. CONCLUSION: The InterPIP App offers a unique opportunity to bring evidence-based guidance to the point of care. Formal evaluation of end-user experiences identified opportunities for quality improvement, and informed plans for future development and evaluation.

IWII Wound Infection in Clinical Practice consensus document: 2022 update.

ABSTRACT: Wound infection is a major challenge for clinicians globally, with accurate and timely identification of wound infection being critical to achieving clinical and cost-effective management, and promotion of healing. This paper presents an overview of the development of the International Wound Infection Institute (IWII)'s 2022 Wound Infection in Clinical Practice consensus document. The updated document summarises current evidence and provides multidisciplinary healthcare providers with effective guidance and support on terminology, paradigms related to biofilm, identification of wound infection, wound cleansing, debridement and antimicrobial stewardship. Integral to the update is revision of wound infection management strategies which are incorporated within the IWII's Wound Infection Continuum (IWII-WIC) and management plan. The aim of the 2022 IWII consensus document update was to provide an accessible and useful clinical resource in at least six languages, incorporating the latest evidence and current best practice for wound infection and prevention. Dissemination techniques for the consensus are discussed and highlighted.

Establishing a consensus on wound infection definitions.

OBJECTIVES: The aim of this study was to establish an international, interorganisational consensus on wound infection terminology. METHODS: This project consisted of definition scoping and a Delphi process to produce a consensus glossary for 18 wound infection terms. Recent guidelines/consensus documents were reviewed to identify 2-4 definitions for each term. An online consensus process was undertaken using the RAND Appropriateness Method, a consensus method for panels to reach agreement. International wound organisations nominated experts to participate, from whom 21 participants were selected to represent different organisations, geographic regions and disciplines. In the first consensus round, each term was presented alongside 2-3 definitions and participants nominated their preferred definition, with the majority vote used to select a baseline definition. The consensus process then proceeded, with participants using a 9-point Likert scale to score their level of agreement or disagreement with the definition for each term. Participants also provided a justification outlining the reason behind their rating. At the end of each round, an index was calculated to provide a quantitative evaluation indicating whether agreement or disagreement had been reached. RESULTS: Reasoning statements were summarised and the definitions were adjusted to incorporate concepts identified by participants. The adjusted definition was presented in the next consensus round, together with the reasoning statements. Terms for which a final definition was not achieved in three consensus rounds were finalised with preferential voting using 2-3 definitions that had reached consensus. PROJECT PROGRESS AND SIGNIFICANCE: The project generated a glossary of wound infection terms, endorsed through participation of 15 international organisations, for dissemination of guidelines and clinical decision-making/teaching tools.

A Consensus on Stomal, Parastomal, and Peristomal Complications.

OBJECTIVE: To establish a consensus on terminology used to define stomal, parastomal, and peristomal complications in Australia. METHODS: A list of stomal, parastomal, and peristomal complications was generated through group dialogue, which was informed by clinical and academic knowledge of the researchers. An extensive literature review was undertaken to identify any additional terms and to create a database of definitions/descriptions. A library of images related to the identified conditions was generated. An online Delphi process was conducted among a representative, purposive sample of Australia expert wound, ostomy, and continence nurses and colorectal surgeons. Ten terms were presented to the panel with descriptive photographs of each complication. Up to three Delphi rounds and, if necessary, a priority voting round were conducted. RESULTS: Seven of the 10 terms reached agreement in the first round. One term ( allergic dermatitis ) was refined ( allergic contact dermatitis ) and reached agreement in the second round. Two terms ( mucocutaneous granuloma and mucosal granuloma ) were considered by the panel to be the same condition in different anatomical locations and were combined as one term ( granuloma ). Two terms ( skin stripping and tension blisters ) were combined as one term ( medical adhesive-related skin injury ) and reached agreement in round 2. CONCLUSIONS: A consensus in terminology used to describe stomal or parastomal/peristomal complications will enhance communication among patients and health professionals and advance opportunities for education and benchmarking of stomal, parastomal, and peristomal complications nationally.

Australian guideline on wound healing interventions to enhance healing of foot ulcers: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Diabetes-related foot ulceration (DFU) has a substantial burden on both individuals and healthcare systems both globally and in Australia. There is a pressing need for updated guidelines on wound healing interventions to improve outcomes for people living with DFU. A national expert panel was convened to develop new Australian evidence-based guidelines on wound healing interventions for people with DFU by adapting suitable international guidelines to the Australian context. METHODS: The panel followed National Health and Medical Research Council (NHMRC) procedures to adapt suitable international guidelines by the International Working Group of the Diabetic Foot (IWGDF) to the Australian context. The panel systematically screened, assessed and judged all IWGDF wound healing recommendations using ADAPTE and GRADE frameworks for adapting guidelines to decide which recommendations should be adopted, adapted or excluded in the Australian context. Each recommendation had their wording, quality of evidence, and strength of recommendation re-evaluated, plus rationale, justifications and implementation considerations provided for the Australian context. This guideline underwent public consultation, further revision and approval by ten national peak bodies. RESULTS: Thirteen IWGDF wound healing recommendations were evaluated in this process. After screening, nine recommendations were adopted and four were adapted after full assessment. Two recommendations had their strength of recommendations downgraded, one intervention was not currently approved for use in Australia, one intervention specified the need to obtain informed consent to be acceptable in Australia, and another was reworded to clarify best standard of care. Overall, five wound healing interventions have been recommended as having the evidence-based potential to improve wound healing in specific types of DFU when used in conjunction with other best standards of DFU care, including sucrose-octasulfate impregnated dressing, systemic hyperbaric oxygen therapy, negative pressure wound therapy, placental-derived products, and the autologous combined leucocyte, platelet and fibrin dressing. The six new guidelines and the full protocol can be found at: https://diabetesfeetaustralia.org/new-guidelines/ CONCLUSIONS: The IWGDF guideline for wound healing interventions has been adapted to suit the Australian context, and in particular for geographically remote and Aboriginal and Torres Strait Islander people. This new national wound healing guideline, endorsed by ten national peak bodies, also highlights important considerations for implementation, monitoring, and future research priorities in Australia.

An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline.

BACKGROUND: Consumer engagement is a requirement of high quality clinical guidelines. Developing strategies to engage consumers and incorporate the perspectives of individuals with or at risk of pressure ulcers/injuries and their informal caregivers was one priority in the recent update of the EPUAP/NPIAP/PPPIA's Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. AIMS: The aims were to determine the goals of individuals and caregivers for pressure ulcer/injury care, priorities for pressure ulcer/injury education and biggest problems related to pressure ulcers/injuries. METHODS: An online, anonymous, international 10-item survey, accessible in nine languages was provided to individuals and their caregivers from April to October 2018. Descriptive statistics were used for quantitative data and a thematic analysis approach was used to analyse qualitative data. RESULTS: There were 1233 individuals from 27 countries who completed the survey. Overall, individuals and caregivers had similar goals of care. Reducing the size of pressure ulcer/injury was selected more often as a care goal than complete healing. Individuals, compared to caregivers, considered managing pain more important. Qualitative data analysis identified five themes including knowledge, attitudes, and skills; risk factors for pressure ulcer/injury; accessing pressure ulcer/injury care; quality of life for patients and caregivers; and the pressure ulcer/injury. CONCLUSIONS: The consumer survey provided consumer engagement and perspective that was incorporated into guideline development, including consideration during evaluation of the relevance and acceptability of recommendations, and assignment of recommendation strength ratings.

Wound healing with "spray-on" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial.

There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or standard care interventions for large (>6 cm2 ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm2 . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).

Pressure ulcer/injury classification today: An international perspective.

There has been an ongoing debate in the healthcare community about what pressure ulcers/injuries are, and how to name, define and classify them. The aim of this discussion paper is to provide a brief theoretical background about pressure ulcer/injury classification, to explain the approach the Guideline Governance Group has taken during the 2019 update of the International Guideline for 'Prevention and Treatment of Pressure Ulcers/Injuries' and to share views on how to best implement pressure ulcer/injury classification. First formal pressure ulcer/injury classifications were introduced in the 1950s and today various pressure ulcer/injury classification systems are used worldwide. Dissimilarities between commonly used classification systems may be considered a limitation that impedes clinical and scientific communication. However, the conceptual meaning of pressure ulcer/injury categories described within the various classification systems is comparable and the current evidence does not indicate that one classification is superior to another. Therefore, the Guideline Governance Group created a crosswalk of the major pressure ulcer/injury classifications in common use across different geographic regions. Clinicians are encouraged to use the classification system adopted by their healthcare setting in the most consistent way. The validity of pressure ulcer/injury classification is closely linked to its intended purpose. Studying measurement properties of pressure ulcer/injury classification systems must follow state-of-the-art methods. Structured educational interventions are helpful for improving diagnostic accuracy and reducing misclassification of pressure ulcers/injuries. Implementation of innovative skin and soft tissue assessments and revised pressure ulcer/injury classifications are only worth implementing, when the diagnostic information improves clinical care.

Models for predicting skin tears: A comparison.

A recently published model that predicted the risk of skin tears in older adults was compared with seven additional published models. Four models were excluded because of limitations in research design. Four models were compared for their relative predictive performance and accuracy using sensitivity, specificity, and the area under the curve (AUC), which involved using receiver-operating characteristic analysis. The predictive ability of the skin tear models differed with the AUC ranging between 0.673 and 0.854. Based on the predictive ability, the selection of models could lead to different clinical decisions and health outcomes. The model, which had been adjusted for potential confounders consisted of five variables (male gender, history of skin tears, history of falls, clinical skin manifestations of elastosis, and purpura), was found to be the most parsimonious for predicting skin tears in older adults (AUC 0.854; 81.7% sensitivity; 81.4% specificity). Effective models serve as important clinical tools for identifying older individuals at risk of skin tears and can better direct more timely and targeted prevention strategies that improve health outcomes and reduce health care expenditure.

Spray on skin for diabetic foot ulcers: an open label randomised controlled trial.

BACKGROUND: One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. METHODS: One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed 'spray-on' skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed. DISCUSSION: Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.

A novel topical therapy for resistant and early peristomal pyoderma gangrenosum.

Peristomal pyoderma gangrenosum (PPG) is an under-recognised and difficult condition to treat. We describe a case series using a novel topical combination therapy that promotes wound healing and allows for adhesion of the stoma appliance. A crushed oral prednisolone tablet mixed with Stomahesive Protective Powder (ConvaTec) was applied topically to seven patients with PPG and resulted in pain relief and wound healing in six of seven patients. Only one patient experienced recurrence. The novel topical therapy we describe is cost-effective, readily available, and easily applied in any inpatient or outpatient setting.

The Perth Surgical Wound Dehiscence Risk Assessment Tool (PSWDRAT): development and prospective validation in the clinical setting.

OBJECTIVE: The worldwide volume of surgery today is considerable and postoperative wound healing plays a significant part in facilitating a patient's recovery and rehabilitation. While contemporary surgical procedures are relatively safe, complications such as surgical wound dehiscence (SWD) or breakdown of the incision site may occur despite advances in surgical techniques, infection control practices and wound care. SWD impacts on patient mortality and morbidity and significantly contributes to prolonged hospital stay. Preoperative identification of patients at risk of SWD may be valuable in reducing the risk of postoperative wound complications. METHOD: A three-phase study was undertaken to determine risk factors associated with SWD, develop a preoperative patient risk assessment tool and to prospectively validate the tool in a clinical setting. Phases 1 and 2 were retrospective case control studies. Phase 1 determined variables associated with SWD and these informed the development of a risk assessment tool. Univariate analysis and multiple logistic regression were applied to identify predictors of surgical risk. Phase 2 used the receiver operator curve statistic to determine the predictive power of the tool. Phase 3 involved a prospective consecutive case series validation to test the inter-rater reliability and predictive power of the tool. RESULTS: In addition to those already identified in the literature, one independent risk predictor for SWD was identified: previous surgery in the same anatomical location (p<0.001, odds ratio [OR] 4). Multiple combined factors were integrated into the tool and included: age (p<0.019, OR 3), diabetes (p<0.624, OR 2), obesity (p<0.94, OR 1.4), smoking (p<0.387, OR 2), cardiovascular disease (p<0.381 OR 3) and peripheral arterial disease (p<0.501, OR 3). The predictive power of the tool yielded 71% in a combined data sample. CONCLUSION: Patients with previous surgery in the same anatomical location were four times more likely to incur a dehiscence. Identification of at-risk patients for complications postoperatively is integral to reducing SWD occurrence and improving health-related outcomes following surgery.

Clinical indicators of wound infection and biofilm: reaching international consensus.

OBJECTIVE: To achieve international consensus relating to clinical indicators for a chronic wound, wound infection and biofilm presence to inform the development of international clinical guidance for assessing and managing wound infection. METHOD: An online Delphi consensus process of international key opinion leaders in infection was undertaken. A literature search underpinned the development of issue statements related to terminology, emerging topics and debate in the field of wound infection. Experts participated in three rounds of consensus voting, sharing their opinions and indicating their level of agreement with the issue statements. Votes were calculated using web-based software that implements a nominal group voting methodology previously published by Research and Development/University of California at Los Angeles. RESULTS: A total of 14 experts took part in the development process. Consensus was reached on clinical indicators of wound chronicity, wound infection and biofilm presence. Agreement was also reached that the term 'critical colonisation' should no longer be used to refer to a stage in the wound infection continuum. CONCLUSION: Outcomes from the consensus process were used to inform the development of international, evidence-informed guidance on the assessment and treatment of wound infection to promote improved outcomes for people with wounds.

Prevention and treatment of pressure ulcers/injuries: The protocol for the second update of the international Clinical Practice Guideline 2019.

AIM: The European Pressure Ulcer Advisory Panel, the Pan Pacific Pressure Injury Alliance, and the National Pressure Ulcer Advisory Panel are updating the 'Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline' (CPG) in 2019. The aim of this contribution is to summarize and to discuss the guideline development protocol for the 2019 update. METHODS: A guideline governance group determines and monitors all steps of the CPG development. An international survey of consumers will be undertaken to establish consumer needs and interests. Systematic evidence searches in relevant electronic databases cover the period from July 2013 through August 2018. Risk of bias of included studies will be assessed by two reviewers using established checklists and an overall strength of evidence assigned to the cumulative body of evidence. Small working groups review the evidence available for each topic, review and/or draft the guideline chapters and recommendations and/or good practice statements. Finally, strength of recommendation grades are assigned. The recommendations are rated based on their importance and their potential to improve individual patient outcomes using an international formal consensus process. DISCUSSION: Major methodological advantages of the current revision are a clear distinction between evidence-based recommendations and good practice statements and strong consumer involvement. CONCLUSION: The 2019 guideline update builds on the previous 2014 version to ensure consistency and comparability. Methodology changes will improve the guideline quality to increase clarity and to enhance implementation and compliance. The full guideline development protocol can be accessed from the guideline website (http://www.internationalguideline.com/).

Prevention and Management of Incontinence-Associated Dermatitis in the Pediatric Population: An Integrative Review.

An integrative review was conducted to synthesize evidence on prevention and management of incontinence-associated dermatitis (IAD) in the pediatric population. A 5-step integrative process was used to guide the review. Articles published from January 2000 to April 6, 2017, were identified and retrieved from CINAHL, PubMed, ProQuest (MEDLINE), and Scopus; key terms were associated with IAD, pediatric, prevention, and management. Supplemental and manual searches were carried out to identify other relevant studies. The studies' findings were extracted and summarized in a table of evidence, with their quality evaluated using the Joanna Briggs Institute's Critical Appraisal Checklist. Sixteen articles were included in the review. Articles explored prevention and management strategies including skin cleansing technique, diaper selection, and the application of topical skin care products. Inconsistent and limited evidence was found regarding the benefits of using disposable wipes in preference to water-moistened washcloths in the cleansing process and on the use of superabsorbent polymer diapers with breathable outer lining in IAD prevention. Findings were inconclusive with regard to the best topical skin care product for IAD care. However, the application of skin protectants was encouraged by the authors, as well as promoted in various clinical guidelines. The development of a structured skin care regimen supplemented by a comprehensive patient education program was advised to enhance the prevention and management of IAD.

A risk model for the prediction of skin tears in aged care residents: A prospective cohort study.

The objective of this study was to construct a predictive model to identify aged care residents at risk of future skin tears. Extensive data about individual characteristics, skin characteristics, and skin properties were gathered from 173 participants at baseline and at 6 months. A predictive model, developed using multivariable logistic regression, identified five variables that significantly predicted the risk of skin tear at 6 months. These included: a history of skin tears in the previous 12 months (OR 3.82 [1.64-8.90], P = 0.002), purpura ≤20 mm in size (OR 3.64 [1.42-9.35], P = 0.007), a history of falls in the previous 3 months (OR 3.37 [1.54-7.41], P = 0.002), clinical manifestations of elastosis (OR 3.19 [1.38-7.38], P = 0.007), and male gender (OR 3.08 [1.22-7.77], P = 0.017). The predictive model yielded an area under the receiver operating characteristic curve of 0.854 with an 81.7% sensitivity and an 81.4% specificity. This predictive model could inform a simple but promising bedside tool for identifying older individuals at risk of skin tears.

Priority issues for pressure injury research: An Australian consensus study.

Pressure injuries are a significant health concern in all clinical settings. The current body of research on pressure injuries reported in the literature presents primarily low level evidence. The purpose of the current study was to identify and prioritize pressure injury research issues. The approach entailed evidence scoping and implementing a formal consensus process using a modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. Sixteen Australian pressure injury experts participated in five consensus voting rounds in May to June 2015. From 60 initial research issues, the experts reached agreement that 26 issues are a priority for future pressure injury research. The highest priorities were strategies to assess skin and tissues, appropriate outcome measures for indicators of pressure injury healing and recurrence, heel pressure off-loading and shear reduction strategies, economic cost of pressure injuries and their management and effectiveness of skin moisturizers and barrier products. Developing a prioritized research agenda, informed by clinical and academic pressure injury experts, can assist in reducing the burden of pressure injuries by identifying topics of the highest need for further research. A web-based nominal group voting process was successful in engaging expert decision-making and has wide-reaching international appeal in facilitating cost-effective consensus methodologies. The priority list generated from this research is currently used in Australia to inform government investment in pressure injury research.