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Pressure Injury clinical trials

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NCT ID: NCT06435143 Not yet recruiting - Pressure Injury Clinical Trials

Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2

IESPI
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The focus of this study will be early stage pressure ulcers, which can quickly progress to stage 3, 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.

NCT ID: NCT06369688 Not yet recruiting - Pressure Ulcer Clinical Trials

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

IdealSkinCares
Start date: October 1, 2025
Phase: N/A
Study type: Interventional

The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.

NCT ID: NCT05946291 Not yet recruiting - Pressure Injury Clinical Trials

Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

When the literature is examined, it is seen that the pressure injury knowledge and evaluation levels of nursing students are low. Today, innovative approaches have started to be introduced to nursing education in proportion to the development of technology. Simulation applications are also seen as one of these innovative approaches. In our study, it is aimed to examine the effect of pressure injury training to be given using high-reality standardized patient use and a medium-reality simulation model on the knowledge and evaluation level of intern nursing students. Students (n = 250) will be assigned blindly to the experimental and control groups using a simple randomization method, and then pressure injury information and assessment trainings will be given to the experimental group with a medium-reality simulation model on a standardized patient for the control group for 4 weeks. After 2 weeks, the final test will be performed, and the data will be assigned to blind groups. It will be evaluated by the researcher.

NCT ID: NCT05877378 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy of PICO Single-use System in Chronic Ulcers

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.

NCT ID: NCT05564975 Not yet recruiting - Pressure Injury Clinical Trials

Construction and Application of Pressure Injury Risk Prediction Model for Critically Ill Patients

Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

In the previous investigation, investigators found that when the risk factors of stress injury in critical patients changed, clinical nurses lacked the awareness of evaluating the risk of stress injury, and lacked the risk assessment of this link. The stress risk prediction model is based on etiology. By analyzing the risk factors, the machine learning algorithm is used to evaluate the risk of pressure damage, and the prediction model of pressure damage can dynamically and comprehensively evaluate its risk. It is also a risk assessment tool. At present, there is no research on applying the stress injury risk prediction model of critical patients to the intensive care information software in China. In this study, the artificial intelligence algorithm library will be used to construct and apply the stress injury risk prediction model for critical patients.

NCT ID: NCT05549830 Not yet recruiting - Injuries Clinical Trials

Effect of Different Positioning Before, During and After Surgery on Pressure Injury

Start date: October 2022
Phase: N/A
Study type: Interventional

Background: Patients undergoing surgery are at risk of developing pressure injuries since they remain in a fixed position on the operating table under anesthesia for a long time. In the management of surgical patients, the prevention of surgical pressure injuries is the best strategy, requiring effective risk assessment and timely implementation of preventive interventions. Aim: To evaluate the effect of preoperative and postoperative patient repositioning other than intraoperative positions on the development of pressure injuries. H1 Hypothesis: In the preoperative and postoperative periods, there is a significant difference in the development of pressure injuries between patients who have been repositioned using non-surgical positions compared to those that did not undergo this intervention. Methods: This study has been designed as a prospective randomized controlled trial. Patients meeting the inclusion criteria of the trial will be allocated to the intervention and control groups using a random number generator. The participants to be assigned to the intervention group will be placed in different positions other than their surgical positions on the night before surgery and until the first 36 hours after the operation, while the control group will only receive routine care. The groups will be evaluated in terms of pressure injury development for at least 72 hours until the end of the postoperative sixth day or discharge from the hospital.

NCT ID: NCT05363475 Not yet recruiting - Surgical Wound Clinical Trials

Implementation and Evaluation of CBPM Technology

CBPM
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Background & Rationale: Pressure injuries are costly to treat and are prevalent in about 26% of patients across all healthcare settings in Canada. Wounds Canada has developed recommendations for prevention and management to tackle this problem that include pressure injury risk assessment, pressure relief surfaces, nutrition, wound monitoring, and wound care. Continuous bedside pressure mapping (CBPM) technology can assist with effective repositioning of patients to prevent pressure injuries. The ForeSite Intelligent Surface system (ForeSite IS) is a CBPM technology that uses machine learning and artificial intelligent software for more intuitive repositioning of patients. Various studies have shown the technology to be effective in reducing pressure injuries and providing adequate pressure redistribution for patients with a PI flap reconstruction. Furthermore, some studies have indicated the device's cost savings, but there are no known publications on cost-effectiveness. Despite the few studies evaluating CBPM technology, few have implemented it in nursing care. Particularly in Canada, there are no guidelines for incorporating CBPM technology into pressure injury prevention care plans or post-surgical recovery in any healthcare setting. Research Question and Objectives: In this study we will be piloting the ForeSite IS system in long-term care, acute care, plastic surgery and trauma patients to further identify the benefits of utilizing the device and evaluate its implementation. The primary objectives are: 1. To determine if the ForeSite IS system can be incorporated in improving quality of care for at risk patients by providing continuous skin exposure monitoring 2. To determine if the ForeSite IS system can provide evidence of skin breakdown to reduce the incidence and risk of PIs 3. To determine if the ForeSite IS system can assist with offloading of pressure to improve healing of post-surgical patients The secondary objectives are: 1. To determine if the device improves nursing workflow and productivity 2. To determine the cost-effectiveness of using the ForeSite IS system Methods: The ForeSite IS system will be piloted in long-term care and acute care for six months. The researchers will identify patients with nursing staff and get permission to approach them. Once permitted, they will explain the study and obtain written consent from patients who agree to participate. Nursing staff will be responsible for setting up and removing the device from the patient's bed. For the first 48 hours of monitoring with the device, no visual feedback (blinded period) will be provided to the nursing staff to collect interface pressure and patient repositioning data on current care practices. Nursing staff will then have another 48 hours to use the visual feedback from the device and acclimatize to the device (acclimatization period). Afterwards, nursing staff will use the visual feedback for the remainder of the patient's two to three weeks of monitoring (active period), depending on the clinical setting. Nurses will continue with routine skin assessments throughout the entire monitoring with additional skin assessments if prompted by the visual feedback during the active period. Interface pressure and patient repositioning in the first 48-hour blinded period will be compared to the monitoring period after the 48-hour acclimatization period. After implementation of the pilot, clinical outcomes will be compared to clinical outcomes of a six-month period prior to the pilot. Pre-implementation focus groups/interviews will be conducted with nursing staff to help each clinical setting develop a protocol for using the ForeSite IS system and develop strategies for implementation. Post-implementation focus groups/interviews will be conducted one to two months after implementation of the system to understand the system's barriers, facilitators, and sustainability aspects.

NCT ID: NCT04008160 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Intelligent Underwear (IU) in Paraplegics

ProTex
Start date: October 1, 2022
Phase:
Study type: Observational

Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting. The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately. 10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.

NCT ID: NCT03965169 Not yet recruiting - Pressure Injury Clinical Trials

Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Patients undergoing surgery under general anesthesia are susceptible to pressure-induced soft tissue damage because there is no change in posture over an extended period of time. In particular, when the patient is in a prone position, unlike the supine position, the bony protruding portion of the front side must support the weight, which is more vulnerable to pressure injury. Previous studies have shown that the incidence of pressure injury during surgery varied from 5% to 66% and was more likely to occur in patients with long operating times, prone position, obesity, and poor skin condition. These pressure injuries increase postoperative complications, length of stay, and medical costs. Therefore, the investigators analyze the incidence of pressure injury in prone position and re-examine the risk factors of pressure injury.