Active clinical trials for "Crush Injuries"

The goal of this [type of study: randomized controlled clinical trial] is to [Determining the effect of prolotherapy use on the wound care process]. The main question it aims to answer is: • [The use of proliferative substances in the care of 1st, 2nd and 3rd stage pressure injuries has a positive effect on the wound healing period]. Participants will [in patients with pressure injuries, wound irrigation with saline and wound irrigation with gelofusin were applied]. Researchers will compare [depth, length and width of the wound].

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: 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 To determine if the ForeSite IS system can provide evidence of skin breakdown to reduce the incidence and risk of PIs To determine if the ForeSite IS system can assist with offloading of pressure to improve healing of post-surgical patients The secondary objectives are: To determine if the device improves nursing workflow and productivity 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.

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.

The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching. The hypothesis are: H1: The knowledge of the students who received the model-based structured pressure injury risk management teaching with the CDSS integrated method is different from the control group who received the standard training. H1a: The attitudes of the students who received the model-based structured pressure injury risk management instruction with the CDSS integrated method to prevent injuries are different from the control group who received the standard training. H1b: The nursing interventions planned by the students who received the model-based structured pressure injury risk management education with the CDSS integrated method are different from the control group who received the standard education.

This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.

The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.

The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds.

The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of BMS-986205 twice during the course of the study.

Study context: Some HIV-positive patients have difficulties with oral administration of antiretroviral drugs, such as children and adults suffering from ENT cancer. It is therefore necessary to offer these patients an alternative: administering the triple therapy in a liquid or well crushed form would be alternatives to a solid tablet, conditional on demonstrating their bioequivalence and that they are well tolerated (taste in particular). Objectives: The investigator's primary intention is to demonstrate the bioequivalence of each of the three active ingredients in Biktarvy® (single daily tablet made up of a set combination of tenofovir alafenamide/emtricitabine/bictegravir: TAF/FTC/BIC) by administering the drug in the forms of a complete and solid tablet (phase S), a tablet dissolved in water (phase D) or a tablet crushed and suspended in apple compote (phase C). The secondary objectives are to compare the safety, tolerance (taste in particular) and preference of healthy volunteers after administration of Biktarvy®, depending on the three methods of oral administration. Equipment and methods: This is a phase I, monocentric, open, three-period, randomised, cross-over trial that will be conducted with 18 healthy volunteers (9 men, 9 women) above the age of 18 in a French university hospital (Caen University Hospital - CHU de Caen). The healthy volunteers will be randomised to receive three different forms (solid, dissolved or crushed) in a varying order, according to the randomisation, at an interval of 14 to 28 days. After each of the three doses, the volunteers will be hospitalised for 24 hours and will then return three times to carry out the pharmacokinetic study with samples taken at the following times: 0 h (right before taking Biktarvy®); 0.5 h; 1 h; 1.5 h; 2 h; 2.5 h; 3 h; 4 h; 8 h; 12 h; 24 h; 36 h; 48 h and 72 h (after Biktarvy®). The plasma concentration in antiretroviral drugs will be analysed by liquid chromatography-mass spectrometry (QTRAP 5500, Sciex, Les Ulis, France) at Orléans Regional Hospital (CHR d'Orléans). The bioequivalence between administration methods D or C will be demonstrated if the confidence interval at 90% (CI 90%) of the ratio parameters Cmax, AUC0-72h and AUC0-∞ is included in the 80%-125% range of those obtained for administration method S and for the three active ingredients. Hypothesis tested: Oral administration of Biktarvy® tablets dissolved in water (as a liquid solution) or crushed and administered in an apple compote is bioequivalent to the solid form (entire tablet swallowed with water) with regard to the three active ingredients that make up Biktarvy®. This means that these methods could be offered to patients who have difficulties with swallowing tablets. Preliminary data must be obtained using healthy volunteers.

The first aim of the study is to prove that after starting the therapy with crushed tablets, the platelet inhibition will be as expected after starting therapy with intact tablets. Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from baseline platelet aggregation of >10% 4 hours after last maintenance dose. So the investigators expect that after 3 days of treatment, all of our patients will have a closing time of more than 106seconds. The investigators will observe two different clinical conditions of Acute Coronary Syndrome. First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients after cardiac arrest. Both are clinical situations in which crushed tablets are needed to give. The second objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg start-dose. Determination of plasma concentrations is done after protein precipitation, by using liquid chromatography with mass spectrometry detection. Measurements will be determined before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h this will be a crushed tablet and 4 hours after the first intake at day 4 of therapy, this will be a non crushed tablet.