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41 clinical studies listed.

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Pressure Injury

Tundra lists 41 Pressure Injury clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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RECRUITING

NCT06529094

Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.

Gender: All

Ages: 18 Years - Any

Updated: 2026-10-19

7 states

Spinal Cord Injury
Pressure Injury
ENROLLING BY INVITATION

NCT07851519

Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.

This pilot study aims to evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries (PIs) in the perineal-sacral area among incontinent inpatients. Incontinence leads to prolonged exposure of skin to moisture and irritants, resulting in Incontinence-Associated Dermatitis (IAD) and increased vulnerability to PIs. Currently, barrier products are applied reactively after skin redness appears. The proposed intervention introduces a proactive approach-daily application of barrier spray during routine morning care before visible damage occurs. Forty inpatients aged65 or above will be recruited from an acute medical ward over 12weeks. Participants admitted in weeks1-6 will receive usual care (control), and those in weeks7-12 will receive the proactive protocol (intervention). Each will be observed for up to14days or until discharge or skin breakdown. The primary outcome is the incidence of new Stage1-2PIs in the perineal-sacral area; secondary outcomes include IAD incidence, nursing compliance, workload, and cost comparisons. This minimal-risk study uses only approved hospital products, follows standard hygiene and safety procedures, and emphasizes proactive prevention to enhance patient outcomes, nursing efficiency, and resource sustainability. Results will guide future large-scale implementation of standardized moisture-care practices.

Gender: All

Ages: 65 Days - Any

Updated: 2026-10-07

Pressure Injury
Pressure Injury Prevention
COMPLETED

NCT06127524

Skin Change Actions by Nursing

Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff. In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes. The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.

Gender: All

Ages: 18 Years - Any

Updated: 2026-10-06

1 state

Pressure Injury
ACTIVE NOT RECRUITING

NCT07853534

Machine Learning-Based Pressure Injury Staging and Nursing Care in Intensive Care

This study aims to develop a mobile nursing care system that uses machine learning to support pressure injury staging and to evaluate its effect on pressure injury healing in an intensive care unit. The system will provide stage-based care guidance and support wound monitoring. The clinical evaluation will use a quasi-experimental, pretest-posttest design with a control group. A total of 70 patients with pressure injuries are planned to be included: 35 in the intervention group and 35 in the control group. Data will be collected using a patient information and monitoring form, the Braden Scale, and the Bates-Jensen Wound Assessment Tool. Changes in wound condition and healing will be compared between the groups.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-10-01

1 state

Pressure Injury
COMPLETED

NCT07848685

Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home

Pressure ulcers remain a significant healthcare burden in community and home care settings, particularly among immobile patients. Effective prevention strategies require caregiver education and implementation of evidence-based care bundles. The SSKIN care bundle (Surface, Skin inspection, Keep moving, Incontinence management, Nutrition) is an internationally recognized approach, but its effectiveness when implemented by informal home caregivers using culturally adapted materials remains unclear. This study aimed to compare the knowledge and competency of informal caregivers who received structured training on the SSKIN care bundle versus those receiving traditional verbal instructions, and to evaluate the impact of this training on the incidence of pressure ulcer development in community-dwelling patients at risk for pressure ulcers. Eligible patients were ≥18 years old, at risk for pressure ulcers due to limited mobility (bed-bound or requiring mechanical assistance for repositioning), able to provide informed consent, and receiving home health care services. Eligible caregivers were informal or hired caregivers responsible for daily patient care. Primary outcomes included the caregivers' knowledge of pressure ulcer prevention, assessed via pre-test and post-test questionnaires and the incidence of new pressure ulcers developed during the 6-month follow-up period. Secondary outcome was the mortality rate during the study period.

Gender: All

Ages: 18 Years - Any

Updated: 2026-09-30

1 state

Pressure Ulcer (PU)
Pressure Injury
Wounds and Injuries
RECRUITING

NCT06999590

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

Gender: All

Ages: 18 Years - Any

Updated: 2026-09-23

1 state

Pressure Ulcer
Ulcer
Ulcer, Pressure
+1
NOT YET RECRUITING

NCT07789613

Clinical and Cost-Effectiveness of an Artificial Intelligence -Synthesized Nursing Care Bundle for Preventing Medical Device-Related Pressure Injuries

Medical device-related pressure injuries (MDRPIs) are an important and largely preventable patient safety problem, particularly in intensive care units where the use of medical devices is frequent and prolonged. A recent meta-analysis reported an MDRPI incidence of approximately 19% among adults in critical care settings. Although evidence-based recommendations for MDRPI prevention are available, their consistent and sustainable integration into routine nursing care remains challenging. Care bundles may facilitate the translation of evidence into routine clinical practice; however, existing MDRPI prevention bundles vary considerably in their components and implementation strategies, and evidence regarding their clinical and economic effectiveness remains limited. This study aims to develop an artificial intelligence (AI)-synthesized nursing care bundle for the prevention of MDRPIs and to evaluate its clinical effectiveness and cost-effectiveness compared with routine care. The care bundle will consist of 3-5 evidence-based components identified through a systematic review of the literature and AI-assisted evidence synthesis. The draft bundle will subsequently be evaluated and finalized through a two-round Delphi process involving experts with experience in MDRPI prevention. Before clinical implementation, participating nurses will receive standardized training, and their adherence to the care bundle will be assessed by the research team, with an adherence level of ≥95% required before implementation. The clinical effectiveness of the finalized care bundle will be evaluated in a randomized controlled trial conducted in an adult intensive care unit. A total of 220 patients will be allocated in a 1:1 ratio, using blocked stratified randomization based on MDRPI risk level, to either the intervention group receiving the AI-synthesized nursing care bundle or the control group receiving routine care. All medical devices in place at enrollment will be recorded, and participants will be followed for up to 14 days; the primary outcome will be the occurrence of an MDRPI related to these devices during the follow-up period. An economic evaluation will be conducted from the hospital perspective based on product utilization, nursing labor time, and hospitalization-related resource use, and the cost-effectiveness of the intervention will be assessed using the incremental cost-effectiveness ratio.

Gender: All

Ages: 18 Years - Any

Updated: 2026-09-17

1 state

Medical Device Related Pressure Ulcer (MDRPU)
Pressure Injury
COMPLETED

NCT06848049

Mobile Application-Assisted Pressure Injury Management

Pressure injuries develop due to decreased movement, especially in bedridden individuals receiving home care. In Turkey, the management of pressure injuries is carried out by nurses in acute and long-term care settings, and mostly by caregivers for individuals receiving home care. Studies have shown that individuals providing home care have a significant need for training. Today, digital health technologies are used to facilitate access to healthcare professionals and provide workload and cost efficiency. Telehealth services in these technologies can be provided via telephone or mobile applications. In this context, the aim of the study is to examine the effect of nursing services provided via mobile applications on the management of pressure injuries in individuals receiving home care. The study was designed as a randomized controlled experimental type. In the power analysis conducted to calculate the sample size, the sample size was determined as 56, and considering that there may be data losses, 60 people will be included in the study. The "Structured Information Form, Pressure Injury Information Form for Caregivers, Pressure Injury Skill Checklist for Caregivers, and Pressure Injury Follow-up Form" will be used as data collection tools in the study. In this study, it is thought that the nurse's remote monitoring of individuals receiving home care with a mobile application in the management of pressure injuries will contribute to patient safety and care costs.

Gender: All

Ages: 18 Years - Any

Updated: 2026-09-04

Pressure Injury
Nursing Caries
Application Site Wound
RECRUITING

NCT07779395

Artificial Intelligence-Supported Pressure Injury Prevention and Care in Intensive Care Patients

This study evaluates the effect of an artificial intelligence-supported mobile application, PRESS AI, on pressure injury prevention and nursing care in adult intensive care patients. The application supports nurses in pressure injury risk assessment, wound assessment and staging, and selection of appropriate prevention and care interventions. The study compares the incidence of hospital-acquired pressure injuries before and after the implementation of PRESS AI. During the pre-intervention period, patients receive routine pressure injury prevention and nursing care. During the intervention period, nurses use PRESS AI together with an integrated pressure injury prevention and care algorithm to support clinical assessment and care planning.

Gender: All

Ages: 18 Years - Any

Updated: 2026-08-21

1 state

Pressure Injury
COMPLETED

NCT06294327

RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress

Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%). The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings. This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-27

1 state

Pressure Injury
Pressure Ulcer
Decubitus Ulcer
RECRUITING

NCT05243966

Myriad™ Augmented Soft Tissue Reconstruction Registry

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-15

12 states

Abdominal Wound Dehiscence
Necrotizing Soft Tissue Infection
Lower Extremity Wound
+4
ENROLLING BY INVITATION

NCT07691710

Arterial Blood Gas Levels, Oxygen Saturation, and Pressure Injury Risk in ICU Patients

The purpose of this study is to examine the relationship between arterial blood gas (ABG) parameters and oxygen saturation (SpO₂) levels and the risk of pressure injury development in patients hospitalized in intensive care units, and to provide a scientific contribution to the processes for assessing pressure injury risk based on the findings obtained.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-09

1 state

Pressure Injury
Intensive Care Unit (ICU)
COMPLETED

NCT06977152

Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head

This study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients. H1: There is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients. H2: The fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow. H3: There is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow. H4: The anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used. H5: Compared to the memory foam pillow, the fluidized positioner is associated with a more homogeneous pressure distribution across the occipital, parietal, and temporal regions.

Gender: All

Ages: 28 Days - 5 Years

Updated: 2026-06-18

1 state

Pressure Injury
ENROLLING BY INVITATION

NCT04726306

Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System

This validation study investigates the diagnostic precision and accuracy when grading otic barotrauma using two alternative gradings systems including the TEED and the OGS grading systems. Background There are two grading systems used to grade otic barotrauma. They include the Teed Score (TEED) and the O'Neill Grading System (OGS). Teed has been utilized more extensively but among physicians has been found to have limitations. The OGS is an alternative grading system with less classification categories than what the Teed classification system utilizes. The OGS system is tied directly to treatment decision making, specific to the respective grading level. Methods This study will utilize a sample of clinical examiners who will independently grade 120 digital color photos of actual patient tympanic membranes with and without evidence of eustachian tube dysfunction and middle ear barotrauma including variable stages or grades of otic barotrauma. They will use the TEED chart as a reference in selecting the appropriate TEED score for each of the photos. Simultaneously they will also utilize the OGS chart as a reference in selecting the appropriate OGS grade for each of the photos. The grading will be conducted by physicians, nurses, and technicians. This will allow for comparisons at varying provider levels. The comparisons will be made using the kappa statistics across the disciplines. This will allow comparison between observed agreement, and expected agreement due to chance for all reviewers. Research Hypothesis Ho: There is no difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems. Ha: There is a difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems.

Gender: All

Updated: 2026-06-10

1 state

Otic Barotrauma
Pressure Injury
Ear Injury
+2
COMPLETED

NCT04804098

Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.

Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.

Gender: All

Updated: 2026-06-09

1 state

Ear Barotrauma
Middle Ear Disease
Ear Diseases
+4
RECRUITING

NCT07523958

Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery

This randomized controlled trial aims to evaluate the effectiveness of topical paraffin oil application in preventing tourniquet-related skin lesions in patients undergoing upper extremity surgery. Pneumatic tourniquets are commonly used to provide a bloodless surgical field; however, they may cause skin complications such as erythema, edema, abrasions, blisters, and burns. In this study, adult patients undergoing elective upper extremity surgery will be randomly assigned to either an intervention group receiving topical paraffin oil application in addition to routine protective dressing or a control group receiving routine care only. Skin integrity will be assessed immediately after tourniquet removal and at 30 and 60 minutes postoperatively using standardized skin assessment criteria. The findings of this study are expected to contribute to the development of effective, simple, and cost-efficient strategies to prevent tourniquet-related skin complications and improve patient safety and postoperative comfort.

Gender: All

Ages: 18 Years - Any

Updated: 2026-06-04

Pressure Injury
Skin Lesions
Skin Injury
NOT YET RECRUITING

NCT07590765

NURSING COMPETENCY SCALE IN PRESSURE INJURY PREVENTION: A SCALE DEVELOPMENT STUDY

Pressure injuries remain an important patient safety problem and are associated with prolonged hospitalization, increased healthcare costs, pain, and reduced quality of care. Nurses play a key role in the prevention of pressure injuries through risk assessment, skin care, positioning, nutritional management, and evidence-based preventive interventions. The purpose of this study is to develop and evaluate the psychometric properties of the Nursing Competency Scale in Pressure Injury Prevention. The scale is intended to assess nurses' competencies regarding pressure injury prevention in line with updated international guidelines. The study will be conducted with nurses working in a training and research hospital in Türkiye. The scale development process will include item generation, expert evaluation for content validity, pilot testing, exploratory factor analysis, confirmatory factor analysis, criterion validity, internal consistency analysis, and test-retest reliability assessment.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-15

Pressure Injury
Nursing Competency
RECRUITING

NCT07158658

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-06

1 state

Pressure Injury
COMPLETED

NCT07565233

Mobile Education for Pressure Injury Prevention and Caregiver Support

This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse-led, mobile health (mHealth) education program for informal caregivers of bedridden patients receiving home healthcare services. The intervention, named the "Mobile Life Without Pressure Injury" application, is theoretically grounded in the Health Belief Model (HBM). The primary objective is to assess the impact of this mobile-based education on three key outcomes: (1) the prevention and risk reduction of pressure injuries in bedridden patients, (2) the level of caregiver burden experienced by primary caregivers, and (3) the coping styles used by caregivers to manage stress. Background: Bedridden patients are at high risk for developing pressure injuries, a largely preventable complication that causes significant pain, morbidity, and healthcare costs. The responsibility for daily care often falls on informal family caregivers. These caregivers frequently lack formal training in pressure injury prevention, which can lead to increased psychological stress, feelings of helplessness, and a heavy caregiver burden. While mobile health applications offer a promising channel for accessible education, there is a need for theoretically-driven interventions that target not just knowledge, but also behavioral change and caregiver well-being over the long term. Study Design and Methods: This six-month, parallel-group, randomized controlled trial enrolled 60 patient-caregiver pairs (dyads) from the Home Health Services unit of Balıkesir Atatürk City Hospital in Turkey. Patients were bedridden, free of existing pressure injuries, and assessed as being at low or medium risk according to the Braden Scale. Caregivers were primary informal caregivers who owned a smartphone and had not previously received structured pressure injury prevention education. Participants were randomly assigned using a stratified block randomization method (based on patient risk level and caregiver age) to either the intervention group (n=30) or the control group (n=30). Intervention Group: Caregivers received access to the "Mobile Life Without Pressure Injury" application for six months. The app includes educational modules, daily care tracking, reminder notifications (cues to action), and an "Ask the Expert" feature for direct communication with the research nurse. The educational content was specifically designed to address the components of the Health Belief Model (perceived susceptibility, severity, benefits, barriers, and self-efficacy). Control Group: Caregivers and patients continued to receive standard, routine home healthcare services as defined by national regulations, without any additional structured education or mobile application support. Data were collected through face-to-face home visits at four time points: baseline (pretest), 1st month, 3rd month, and 6th month (posttest). Data collection instruments included a Patient and Caregiver Identification Form, the Braden Scale for Predicting Pressure Sore Risk, the Pressure Injury Assessment Form, the Zarit Caregiver Burden Interview (ZCBI), and the Ways of Coping Inventory (WCI). Outcome Measures: Primary Outcomes: Change in Zarit Caregiver Burden Interview (ZCBI) scores over six months; change in coping styles (Ways of Coping Inventory subscales) over six months. Secondary Outcomes: Incidence of new pressure injuries in patients; change in Braden Scale risk scores over six months; caregiver satisfaction and perceived utility of the mobile application. Statistical Analysis: The primary analysis will evaluate the group x time interaction using repeated measures analysis of variance (ANOVA) or Generalized Estimating Equations (GEE), depending on the distribution of the data. The analyses will follow the intention-to-treat principle. A post-hoc power analysis will be conducted to confirm the achieved statistical power based on the final sample size. Hypothesis: The investigators hypothesize that, compared to caregivers in the control group, caregivers in the intervention group will demonstrate significantly reduced caregiver burden, increased use of active coping strategies, and decreased use of passive coping strategies over the six-month study period. Furthermore, it is hypothesized that patients in the intervention group will exhibit a lower incidence of pressure injuries and improved (higher) Braden Scale scores compared to the control group. Implications: This study aims to provide robust evidence on the efficacy of a theory-based mobile health intervention for supporting informal caregivers. If proven effective, the "Mobile Life Without Pressure Injury" application could serve as a scalable, cost-effective, and accessible model for integrating digital health tools into home healthcare nursing practice to improve both patient safety and caregiver well-being.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-04

1 state

Pressure Injury
COMPLETED

NCT07306143

Prediction of Pressure Injury Risk in ICU Using Data Mining

This study is a retrospective record review conducted among adult patients hospitalized in the intensive care unit of a tertiary hospital between October 10, 2020, and October 10, 2025. The aim of the study is to predict the risk of pressure injury development using demographic, clinical, laboratory, and nursing care-related variables by applying multiple data mining algorithms. No intervention, treatment, or patient contact will occur. All data will be extracted from existing electronic and paper-based medical records and will be fully anonymized prior to analysis. The study poses no risk to participants and will be conducted with approval from the institutional review board or ethics committee.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-01

1 state

Pressure Injury
NOT YET RECRUITING

NCT07537101

Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients

The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients. Does applying this natural gel reduce the incidence of pressure injuries compared to standard care? participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-30

1 state

Pressure Injury
COMPLETED

NCT07553026

ADDIE-Based Training Program for Nurses on Medical Device-Related Pressure Injuries

Medical device-related pressure injuries (MDRPIs) are a significant and increasing problem in clinical settings, particularly in intensive care units, adversely affecting patient outcomes and increasing healthcare costs. Nurses play a critical role in the prevention and management of MDRPIs; however, previous studies have shown that their knowledge and practices in this area are often insufficient. This study aims to develop an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program for nurses and to evaluate its effect on their knowledge and care practices related to MDRPIs. The study is designed as a single-group pretest-posttest pre-experimental study and will be conducted with nurses working in intensive care units. Data will be collected at three time points: before the training (pretest), immediately after the training (posttest), and one month after the training (follow-up). The training program will be delivered face-to-face using structured educational materials. Outcomes will include changes in nurses' knowledge levels and their evaluations of the training program. The findings are expected to contribute to improving nursing care practices and enhancing patient safety by supporting effective prevention and management of MDRPIs.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-27

1 state

Medical Device-Related Pressure Injury
Pressure Injury
Nursing Education
NOT YET RECRUITING

NCT06918548

Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries

This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-07

Pressure Injury
NOT YET RECRUITING

NCT07496411

Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients

Pressure injuries are a common and serious complication for critically ill patients in the intensive care unit (ICU). Early and accurate identification of high-risk patients is crucial for effective prevention. This two-phase sequential study aims to evaluate a new, objective assessment tool: an ultrasound-based quantitative risk score. Phase 1 is an observational study designed to test the predictive validity of this ultrasound score. Researchers will use bedside ultrasound to examine tissue integrity and determine how accurately the score can predict the development of pressure injuries. Phase 2 is a pilot randomized controlled trial. In this phase, patients will be randomly assigned to receive either standard preventive care or a targeted nursing intervention guided by the ultrasound score. The primary goal is to assess the clinical effectiveness of this score-guided intervention in reducing the occurrence of pressure injuries and improving nursing care for critically ill patients.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-06

Pressure Injury