Treatment Of Pressure Injuries Research Articles

Heterogeneous Outcome Selection and Incomplete Prespecification of Outcomes in Systematic Reviews: A Case Study on Pressure Injury.

To understand how reviewers select and prespecify outcomes for systematic reviews (SRs), the authors report on the outcomes used in SRs of pressure injury (PI) intervention and treatment and evaluate their completeness of prespecification. The authors searched four electronic databases for SRs involving PI prevention and/or treatments. Inclusion criteria were SRs and meta-analyses evaluating interventions for preventing or treating PI. Studies without systematic search or risk-of-bias assessment, conference proceedings, and articles not in Chinese or English were excluded. Two reviewers extracted and categorized the outcomes in domains, assessing outcome prespecification using a five-element framework. Data items included study characteristics, target population, type of interventions, and outcome variables. This review included 95 SRs that reported a total of 432 instances of 24 different outcome domains. An average of four outcome domains were reported per SR. The most frequently reported domains were PI healing, PI occurrence, and PI status. Of the 62 SRs that prespecified primary outcomes, 40 (64.52%) reported more than one primary outcome. Only 24 of the 432 instances (5.56%) were completely specified. Among the 24 outcome domains, 12 (50.00%) were listed as primary outcomes at least once. Primary outcomes were more completely specified than nonprimary outcomes. Systematic reviews of PI prevention and/or treatment report diverse, incompletely prespecified outcomes, highlighting the need for a core outcome set to standardize key clinical outcomes.

Point prevalence and risk factors for pressure ulcers in hospitalized adult patients: a cross-sectional study.

To estimate the point prevalence of and risk factors associated with the development of pressure ulcers at a university hospital in Brazil. This study was conducted on 196 participants using a structured questionnaire, physical examination of the skin, and the Braden scale. The Mann-Whitney U, χ2, or Fisher's exact tests were used to compare the participants and the associations of variables with pressure ulcers. A modified multivariate Poisson regression model was built considering the presence of pressure injuries and the independent variables. The point prevalence of pressure ulcers was 10.71% and was significantly associated with less than 12 years of schooling (p=0.0213), use of antihypertensive drugs during hospital stay (p=0.0259), diagnosis of systemic hypertension (p=0.0035), and diabetes mellitus. Lower scores on the Braden scale (p=0.0001) were positively associated with the presence of pressure ulcers. Furthermore, cardiovascular disease (p=0.0267) and diaper use (p=0.0001) were associated with the presence of pressure ulcers. Moreover, they were also associated with prolonged hospital stay, advanced age, less than 12 years of schooling, use of antihypertensive drugs, hypertension, diabetes, and lower Braden scale scores. Health professionals should be aware of the risk factors associated with pressure ulcers, evaluate patient skin daily, and offer prevention. Our findings support the need to allocate resources for the prevention and treatment of pressure injuries.

The Effect of Aloe Vera and Honey Dressings on Preventing Pressure Injuries in High-Risk Elderly ICU Patients: A Randomized Clinical Trial

Background: Today, due to the challenging treatment of pressure injuries, the preferred approach is prevention and care. One preventive measure is the use of specialized dressings, although very few studies have explored this area. Objectives: This study aimed to investigate the impact of using aloe vera and honey on the prevention of pressure injuries among elderly patients admitted to an intensive care unit in Qazvin, Iran, in 2022. Methods: In this randomized, single-blind clinical trial, 90 elderly patients at moderate to high risk of developing pressure ulcers were divided into three groups. Each group received a different preventive dressing on their sacral area twice a day for one week: The first group received aloe vera gel, the second group received honey, and the third group received plain gauze. Data were collected using a demographic information checklist, the Braden scale for predicting pressure injury risk, and a pressure injury grading tool. The data were analyzed using descriptive and analytical statistical tests and statistical software. Results: The mean Braden scale scores for patients in the aloe vera, honey, and simple dressing groups were 10.83 ± 1.41, 10.40 ± 1.52, and 10.30 ± 1.55, respectively (P = 0.40). Ten patients developed pressure injuries (0 in the aloe vera group, 3 in the honey group, and 7 in the simple dressing group). A statistically significant difference was found in the occurrence of pressure injuries between the aloe vera and honey groups compared to the control group (P = 0.015). Conclusions: The study revealed that aloe vera preventive dressing had a significant and favorable effect on pressure injury prevention. Further studies are recommended to validate these findings.

Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial

BackgroundPressure ulcers account for a substantial fraction of hospital-acquired pathology, with consequent morbidity and economic cost. Treatments are largely focused on preventing further injury, whereas interventions that facilitate healing remain limited. Intermittent electrical stimulation (IES) increases local blood flow and redistributes pressure from muscle-bone interfaces, thus potentially reducing ulcer progression and facilitating healing.MethodsThe Pressure Injury Treatment by Intermittent Electrical Stimulation (PROTECT-2) trial will be a parallel-arm multicenter randomized trial to test the hypothesis that IES combined with routine care reduces sacral and ischial pressure injury over time compared to routine care alone. We plan to enroll 548 patients across various centers. Hospitalized patients with stage 1 or stage 2 sacral or ischial pressure injuries will be randomized to IES and routine care or routine care alone. Wound stage will be followed until death, discharge, or the development of an exclusion criteria for up to 3 months. The primary endpoint will be pressure injury score measured over time.DiscussionSacral and ischial pressure injuries present a burden to hospitalized patients with both clinical and economic consequences. The PROTECT-2 trial will evaluate whether IES is an effective intervention and thus reduces progression of stage 1 and stage 2 sacral and ischial pressure injuries.Trial registrationClinicalTrials.gov NCT05085288 Registered October 20, 2021.

Implementation of an Evidence-Based, Content-Validated, Standardized Support Surface Algorithm Tool in Home Health Care: A Quality Improvement Project.

The purpose of this quality improvement project was to provide a standardized, repeatable, and easy-to-use process for selecting a support surface for prevention or treatment of pressure injuries (PIs). The Wound, Ostomy, and Continence Nurses Society Support Surface Algorithm was chosen to guide clinicians in selection of an appropriate support surface. These clinicians provide services to approximately 465,000 patients across the nation annually. This quality improvement project aimed to establish clinician knowledge and comfort levels when recommending a support surface and providing a standardized way to identify the appropriate support surface once a patient had been identified as at risk. The support surface algorithm was incorporated into our agency's electronic medical record (EMR); we chose this interactive algorithm to facilitate support surface selection among clinicians with no specialized expertise in PI treatment or prevention. Clinicians reported an increase in knowledge and comfort levels in the ability to select an appropriate support surface following implementation of the clinical decision support tool. Benchmarking data illustrated a decrease in the year over year aggregate (September 2018 to September 2021) trending for the Centers for Medicare & Medicaid Services quality outcome measures surrounding potentially avoidable events related to PIs. Implementing the support surface algorithm assisted clinicians with support surface selection, elevated and standardized clinician practice, and reduced potentially avoidable events. As a result of this project, the Wound, Ostomy, and Continence Nurses Society Support Surface Algorithm Tool has been fully integrated into our EMR and is a standardized part of our clinical assessment.

A novel deep-learning based weighted feature fusion architecture for precise classification of pressure injury.

Introduction: Precise classification has an important role in treatment of pressure injury (PI), while current machine-learning or deeplearning based methods of PI classification remain low accuracy. Methods: In this study, we developed a deeplearning based weighted feature fusion architecture for fine-grained classification, which combines a top-down and bottom-up pathway to fuse high-level semantic information and low-level detail representation. We validated it in our established database that consist of 1,519 images from multi-center clinical cohorts. ResNeXt was set as the backbone network. Results: We increased the accuracy of stage 3 PI from 60.3% to 76.2% by adding weighted feature pyramid network (wFPN). The accuracy for stage 1, 2, 4 PI were 0.870, 0.788, and 0.845 respectively. We found the overall accuracy, precision, recall, and F1-score of our network were 0.815, 0.808, 0.816, and 0.811 respectively. The area under the receiver operating characteristic curve was 0.940. Conclusions: Compared with current reported study, our network significantly increased the overall accuracy from 75% to 81.5% and showed great performance in predicting each stage. Upon further validation, our study will pave the path to the clinical application of our network in PI management.

Use of Abzolem ® in Pressure Injuries: Experience of an Exploratory Study

Introduction: Pressure injuries represent a significant and prevalent public health problem in bedridden and institutionalized patients. The correct management of pressure injuries is essential for preventing complications, enhancing patient well-being, and reducing the overall burden on healthcare systems. It underscores the importance of a holistic and patient-centered approach to wound care. Preventive measures and the action of a multidisciplinary team are essential to the correct treatment of pressure injuries. There are multiple active dressings and topical solutions to treat and protect the wounds, among them the hyperoxygenated fatty acids, such as Abzolem®. Objective: Evaluate and verify the effectiveness and safety of the use of Abzolem® in the treatment of patients with pressure injuries grade I and II. Materials and methods: an exploratory study was carried out on 6 patients residing in a long-term establishment in Santiago of Chile with grade I and II pressure injuries in which Abzolem® was used for twice-daily dressings. Results: The use of Abzolem® led to a significant improvement in grade I pressure injuries in 10 ± 3 days and grade II pressure injuries in 15 ± 3 days, without related adverse events and with good tolerance by patients. Conclusion: The use of hyperoxygenated fatty acids, such as Abzolem® corresponds to a safe therapeutic alternative, easy to apply, and effective in the treatment of grade I and II pressure injuries.

Effect evaluation of new dressing URGOTULRANGE in the treatment of pressure injury.

Pressure injury (PI) is a local injury of the skin and/or soft tissue located at the bone caused by medical or other equipment and is common in long-term bedridden patients. To investigate the clinical effect of Urgotul foam dressing in the treatment of stage 3 ∼ 4 PI and deep tissue PI. A total of 38 patients with stage 3 ∼ 4 PI and deep tissue PI admitted to Jinan Central Hospital from January 2016 to December 2018 were selected and randomly divided into a control group (dressing change plus silver ion cream dressing) and an observation group (dressing change plus Urgotul Absorb non-border foam dressing), with 19 cases in each group. After 4weeks of treatment, the pain intensity during dressing change and the treatment efficacy for PI wounds were compared between the two groups. There were no differences in gender (P= 0.740), age (P= 0.130), single wound area (P= 0.673), consultation department (P= 0.972), stage (P= 0.740), presence of undermining (P= 0.721), deep tissue PI (P= 0.721), and systemic antibiotic therapy (P= 1.000) between the two groups, which were comparable. The treatment effect of the observation group was better than that of the control group (P= 0.003), and the pain score of the observation group was lower than that of the control group (P< 0.001). Urgotul Absorb non-border foam dressing has a good effect in the treatment of stage 3 ∼ 4 PI and deep tissue PI and can relieve patients' pain, and is thus worth promoting.

Efficacy of recombinant human epidermal growth factor in pressure injury healing: evidence from Chinese randomized controlled trials.

To evaluate the efficacy of recombinant human epidermal growth factor (rhEGF) in healing pressure injuries (PIs). A meta-analysis was conducted of randomized controlled trials (RCTs) involving rhEGF in the treatment of PIs that were identified in PubMed, Web of Science, the Cochrane Library, and China National Knowledge Infrastructure (CNKI). The population, intervention, comparison, outcomes, study design (PICOS) strategy was applied to determine analysis eligibility. The Cochrane risk of bias tool was used, and statistical analysis, including sensitivity analysis, was performed of 3 outcomes indicators: the primary outcome was total efficacy of rhEGF in treating PIs, and the secondary outcomes were the proportion of complete healing and the time to complete healing. Total efficacy refers to the proportion of cases that have been cured, obviously effective, or effective. Complete healing refers to cases where the wound has healed, scabbed, and the scab has sloughed off. Sixteen RCTs were included, comprising a total of 1,206 patients. Study and control group size varied by outcomes. The total effective healing rate in rhEGF group was 97.18%, which was significantly higher than 83.38% in control group (OR: 5.69, [95% CI: 3.61, 8.97], z=7.49, P < .001). The proportion of complete healing in the rhEGF group was 73.30%, which was higher than 39.52% in control group (OR: 3.88, [95% CI: 3.01, 5.01], z=10.39, P < .001). Furthermore, the healing time using rhEGF was shorter (SMD: -2.14 days, [95% CI: -2.60, -1.67], z=9.07, P < .001). Sensitivity analyses indicated that the results were robust. The meta-analysis indicated that rhEGF was effective in healing PIs with few negative effects. Further research beyond Chinese populations involving larger studies and studies that distinguish between results found in using rhEGF alone or in combination are recommended.

Plasma-Based Scaffold Containing Bone-Marrow Mononuclear Cells Promotes Wound Healing in a Mouse Model of Pressure Injury.

Pressure injuries, or pressure ulcers, are a common problem that may lead to infections and major complications, besides being a social and economic burden due to the costs of treatment and hospitalization. While surgery is sometimes necessary, this also has complications such as recurrence or wound dehiscence. Among the newer methods of pressure injury treatment, advanced therapies are an interesting option. This study examines the healing properties of bone marrow mononuclear cells (BM-MNCs) embedded in a plasma-based scaffold in a mouse model. Pressure ulcers were created on the backs of mice (2 per mouse) using magnets and assigned to a group of ulcers that were left untreated (Control, n = 15), treated with plasma scaffold (Plasma, n = 15), or treated with plasma scaffold containing BM-MNC (Plasma + BM-MNC, n = 15). Each group was examined at three time points (3, 7, and 14 days) after the onset of treatment. At each time point, animals were subjected to biometric assessment, bioluminescence imaging, and tomography. Once treatment had finished, skin biopsies were processed for histological and wound healing reverse transcription polymerase chain reaction (RT-PCR) array studies. While wound closure percentages were higher in the Plasma and Plasma + BM-MNC groups, differences were not significant, and thus descriptive data are provided. In all individuals, the presence of donor cells was revealed by immunohistochemistry on posttreatment onset Days 3, 7, and 14. In the Plasma + BM-MNC group, less inflammation was observed by positron emission tomography-computed tomography (PET/CT) imaging of the mice at 7 days, and a complete morphometabolic response was produced at 14 days, in accordance with histological results. A much more pronounced inflammatory process was observed in controls than in the other two groups, and this persisted until Day 14 after treatment onset. RT-PCR array gene expression patterns were also found to vary significantly, with the greatest difference noted between both treatments at 14 days when 11 genes were differentially expressed.

Risk factors of major complications after flap surgery in the treatment of stage III and IV pressure injury in people with spinal cord injury/disorder: a retrospective cohort study

Study designRetrospective cohort study.ObjectivesTo identify risk factors associated with major complications after flap surgery in people with spinal cord injury or disorder (SCI/D) and stage III and IV pressure injury (PI).SettingSwiss hospital specialized in the treatment of people with SCI/D using the Basel Decubitus Approach.MethodsWe examined 60 risk factors for major postoperative complications in PIs over sacrum/coccyx, ischium or trochanter between 01/2016 and 12/2021. We performed descriptive analysis and computed global p-values using likelihood ratio tests adjusted for clustering of PIs in individuals.ResultsWe included 220 PI treatment procedure from 149 individuals. The study population consisted of 163 (74%) men, 133 (60%) traumatic SCI, 136 (58%) stage IV PI, 198 (90%) individuals with paraplegia, 93 (42%) with osteomyelitis, and 85 (39%) with recurrent PI. Major complications 42 (19%) occurred more often in individuals with stage IV PI (p < 0.01), individuals without osteomyelitis (p < 0.03), and individuals with pathological blood concentrations of cystatin c (p < 0.028), calcium (p < 0.048), and vitamin B12 (p < 0.0049) as well as normal blood concentrations of HbA1c (p < 0.033). Immobilization (p < 0.0089) and hospital stay (p < 0.0001) of individuals with major complications was longer.ConclusionIn the Basel Decubitus Approach, stage IV PI, absence of osteomyelitis, reduced vitamin B12 and calcium, elevated cystatin c, and normal HbA1c should be addressed to reduce major complications.

Introduction of augmented reality to the remote wound care nursing consultation system.

We implemented augmented reality (AR) in remote consultations for enhanced pressure injury (PI) care in homecare nursing and improved the efficiency of on-site technical education for homecare nurses. The study aimed to depict expert techniques using AR technology to improve PI healing time in a male patient. We developed and implemented a new system that combines a transparent hand with an image and gives an output as a video image in the existing remote consultation software. The system was used to support remote care of PIs by nurses. We succeeded in superimposing the expert nurse's nonverbal hand gestures onto the patient's wound in real time. The visiting nurse's understanding of the system had improved and there was an improvement in the patient's PI healing. These results suggest that remote consultation using AR is effective to observe precise wound care demonstrations of the steps of the PI treatment and provide effective treatment.

Necessary Products for the Prevention and Treatment of Pressure Injuries: Lessons Learned That Translate Beyond the COVID-19 Pandemic.

To identify the challenges encountered in obtaining the required support surfaces and products to meet pressure injury (PrI) prevention and treatment needs during COVID-19. The authors used SurveyMonkey to gather data on healthcare perceptions and the challenges experienced regarding specific product categories deemed necessary for PrI prevention and treatment in US acute care settings during the pandemic. They created three anonymous surveys for the target populations of supply chain personnel and healthcare workers. The surveys addressed healthcare workers' perceptions, product requests, and the ability to fulfill product requests and meet facility protocols without substitution in the categories of support surfaces and skin and wound care supplies. Respondents answered one of the three surveys for a total sample of 174 respondents. Despite specific instructions, nurses responded to the surveys designed for supply chain personnel. Their responses and comments were interesting and capture their perspectives and insights. Three themes emerged from the responses and general comments: (1) expectations differed between supply chain staff and nurses for what was required for PrI prevention and treatment; (2) inappropriate substitution with or without proper staff education occurred; and (3) preparedness. It is important to identify experiences and challenges in the acquisition and availability of appropriate equipment and products for PrI prevention and treatment. To foster ideal PrI prevention and treatment outcomes, a proactive approach is required to face daily issues or the next crisis.

Under Pressure: Shedding Light on the Issue of Pediatric Pressure Injury Treatment.

Under Pressure: Shedding Light on the Issue of Pediatric Pressure Injury Treatment.

A Prospective, Randomized, Non-inferiority Trial to Compare the Efficacy of 3% Povidone-Iodine Foam Dressing and Silver Foam Dressing in the Treatment of Pressure Injuries

Background: As chronic wounds such as pressure injuries (PIs) are frequently colonized and can easily deteriorate into infection, it is important to reduce their bacterial load, for which antimicrobial dressings can be needed. This study aims to evaluate the efficacy of a 3% povidone-iodine (PVP-I) foam dressing compared to that of a silver foam dressing.Methods: This prospective non-inferiority study was conducted between 2016 and 2019 at three sites in South Korea. A total of 80 PI subjects were randomized to be dressed with either PVP-I foam (experimental group) or silver foam (control group) for up to 8 weeks.Results: Based on the Pressure Ulcer Scale for Healing (PUSH) tool, 25.0% of the experimental groups and 17.5% of the control groups (χ&lt;sup&gt;2&lt;/sup&gt;=0.743, P=0.389) healed by more than 70%. The degree of reduction in wound size was analyzed using Image J, and the experimental and control groups decreased by 41.6%±35.3% and 49.7%±38.2% (t=–0.986, P=0.327), respectively. A Kaplan-Meier survival analysis to confirm the time to heal showed that if more than 30% of the PUSH score was healed, the time to heal was 27.0±9.3 days and 18.0±2.8 days in the two groups (χ&lt;sup&gt;2&lt;/sup&gt;=3.225, P=0.073), respectively. The healing rates at 50 days were 85.8%±8.9% and 93.9%±5.7% in the two groups (P=0.073), respectively. There were no statistically significant differences between the groups in all results.Conclusion: This study demonstrated the non-inferiority of the 3% PVP-I foam dressing compared to the silver foam dressing for PI treatment.

Driving Outcomes and Improving Documentation with Long-Wave Infrared Thermography in a Long-term Acute Care Hospital.

Hospital-acquired pressure injuries (HAPIs) have been increasing nationally, and unfortunately, long-term acute care hospitals (LTACHs) continue to report the highest prevalence and incidence. 1,2 To help reduce HAPI rates and to increase healing rates of all pressure injuries (PIs), including those that are present on admission, a 23-bed LTACH implemented a HAPI prevention and treatment protocol using new technology as a tool for patient skin assessments. A 75-day evaluation using long-wave infrared thermography (LWIT) was conducted for all patients admitted to the facility in conjunction with new PI treatment and prevention bundles that were created by the skin care team. Every PI was imaged using LWIT, which provided a photographic image of the PI, as well as a thermal image of the subcutaneous tissue underneath. This enabled staff to implement treatment and prevention measures as soon as possible. After the 75-day evaluation, the LTACH decided to make LWIT a permanent tool in their HAPI treatment and prevention program. For 10 months, the LTACH sustained a zero HAPI rate using the new treatment and prevention program including LWIT. The LTACH demonstrated that LWIT technology was an invaluable tool in the prevention and treatment of PIs. The use of LWIT has become common practice in this facility. The LTACH facility maintained a zero HAPI rate for 10 months after implementation of LWIT.

Closure of pressure injury and mortality in internal medicine wards.

The prevalence of pressure injury (PI) in hospitalized patients ranges from 5 to 15%, and is significantly greater in critical care and palliative care units. Prevalence of PI is considered an indicator of health care quality and is associated with increased morbidity and mortality. The study aims to determine the features of PI and its association with mortality among hospitalized patients in the inpatient service of a university hospital. The present study comprised 89 patients hospitalized on the internal medicine inpatient service who had PI at the time of hospitalization and or who developed PI during hospitalization. Patients were categorized based on the state of PI closure (complete/incomplete). Mortality rates for 1month, 3months, 6months, and 1year were computed. The median age was 74. (IQR: 62-82). Forty-eight patients were female, and 15.7% of hospitalized patients had PI. A third of patients died during their index hospitalization. Patients with completely closed PI had decreased one-month, three-month, six-month, and one-year mortality rates. Complete closure of PI influenced all four mortality rates independently of other parameters, as determined by Cox regression analysis of the factors impacting mortality. As life expectancy rises, the frequency of PI increases, resulting in a rise in health care expenses. To reduce these expenses, prevention, early identification, and treatment of PI are essential. The primary finding of the study is that complete closure of PI in hospitalized patients reduces the risk of death.

Predictors of one year pressure injury outcomes in hospitalized spinal cord injured veterans with one stage 3 or 4 pressure injury

Objective The purpose of this study is to investigate predictors of pressure injury (PrI) outcomes at one year after discharge for Veterans with spinal cord injury (SCI) hospitalized with a Stage 3 or 4 PrI. Design/Setting/Participants This is a retrospective medical record review from one VA Health Care System SCI unit. Participants were Veterans with traumatic or non-traumatic SCI admitted with one Stage 3 or 4 pelvic PrI treated medically (e.g. without flap surgery). Logistic models were used to select the significant predictors of PrI healing outcomes. Outcome Measure One year after discharge wound outcomes (healed vs non-healed) for Veterans with SCI hospitalized with a Stage 3 or 4 PrI. Results A total of 62 hospitalizations were included for analyses resulting in 33 healed and 29 non-healed PrIs. Three significant predictors of non-healed PrI outcomes included use of pressure mapping during hospitalization, greater PrI depth, and usage of alginate dressings. Two significant predictors of healed PrI outcomes included the use of animal-based tissue and hydrocolloid dressings. Area under curve of this logistic regression model was 79.98%. Conclusion The clinical decision of having a patient pressure mapped predicts that the PrI may not heal at one year of discharge. Pressure mapping protocol correlated with another variable that could not serve as a predictor by itself, including using powered pressure relief techniques. The three PrI treatment predictors may represent characteristics of the PrI itself, rather than the efficacy of the product. Further investigation on these clinical decision-making factors is warranted to ensure efficient and cost-effective treatment strategies for individuals with SCI hospitalized with PrIs.

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

BackgroundProphylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients.MethodsThis is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses.DiscussionThis trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19.Trial registrationANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019

Nurse-led coaching of shared decision-making for wound treatment of pressure injury: A pilot study of a randomized trial.

International guidelines for managing pressure injury (PI) and ulcers recommend that family members and caregivers should be involved in making decisions for appropriate wound care. However, the effect of shared decision-making (SDM) in the context of PI remains unknown. This study investigated the efficacy of nurse-led medical SDM for PI treatment. We constructed a patient decision aid (PDA) for PI treatment on the basis of nursing evidence. Subsequently, we conducted a pilot randomized controlled trial to evaluate the efficacy of SDM compared with that of usual care (control group, [CG]) for PI treatment. Participants with stage 3, stage 4, or unstageable PI were included and randomized into two groups. In the SDM group (SDMG), 10 participants received the SDM intervention for PI before treatment. All participants were followed up for 4 weeks. Primary outcomes were measured using the nine-item SDM Questionnaire (SDM-Q-9) and Decisional Conflict Scale (DCS). Secondary outcomes included wound size and cost of wound management. The expert validity (medical professors and general population) of the PDA designed for PI was measured, and the content validity index was 0.96-0.97. A total of 20 participants were enrolled (10 received SDM and 10 received usual care). The mean age of the participants was 55.7 ± 8.8 years. No significant difference in baseline characteristics (sex, age, staging, or wound area) was observed between the two groups. The SDMG had higher SDM-Q-9 (P < 0.001) and DCS (P < 0.01) scores than did the CG. For the secondary outcomes, the SDMG had a decreased change of wound size and lower wound management costs than did the CG; nevertheless, the differences were not statistically significant. We constructed a PDA for PI treatment, which can be applied in clinical care. The pilot test results revealed that the participants had a lower cost related wound treatment and decreasing wound size in SDMG than CG after the intervention of SDM-PI for 4 weeks. In the future, clinical studies should conduct large-scale randomized trials based on the results of this pilot study.