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Pressure Ulcer clinical trials

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NCT ID: NCT05472974 Completed - Pressure Injury Clinical Trials

Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress

Start date: September 17, 2018
Phase:
Study type: Observational

The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

NCT ID: NCT05461911 Completed - Clinical trials for Pressure Ulcer ( Stage 2-3)

Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy

Start date: June 1, 2021
Phase:
Study type: Observational

A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure ulcers. One of the successful products specially created for the treatment of pressure ulcers and taking into account the results of research is the high-protein, energy-rich, ready-to-use enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral nutritional supplement with an innovative nutrient composition for patients with chronic wounds, including pressure ulcers, or at increased risk of developing them. Taking into account the available data, it seems expedient to continue studying the unique combination of nutrients that make up the study food product Nutrison Advanced Cubison in order to develop the most effective nutritional protocols for patients at risk for the treatment and prevention of pressure ulcers.

NCT ID: NCT05458050 Completed - Pressure Ulcer Clinical Trials

An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers

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

A double blind, non randomized, multicenter investigation

NCT ID: NCT05354687 Completed - Pressure Ulcer Clinical Trials

Comparison of Self Directed Learning and Small Group Teaching Methods on Pressure Injury Assessment

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of pressure injury assessment training given by self-directed learning and small-group teaching methods on the knowledge and skill levels of nursing students: a three-group, pre-test - post-test, randomized controlled, parallel-group experimental study.

NCT ID: NCT05238870 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.

Start date: July 8, 2022
Phase:
Study type: Observational

This is study 1 of 3 - of the overall project: The ProneTection Quality Improvement Project. The three aims of this study, study 1 are: 1. to establish the training needs critical care clinicians have regarding prone positioning, 2. to investigate the conditions for effective implementation as in an intensive care setting, 3. to develop an education and training package (The ProneTection package) for an interdisciplinary team of clinicians on skin damage prevention of patients in the prone position

NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT05142878 Completed - Pressure Ulcer Clinical Trials

What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Pressure ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 20 community patients. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals. A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis. Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions. A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). Static or reactive overlay mattresses are an example of a low-tech constant low pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium. A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population. This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.

NCT ID: NCT05124197 Completed - Pressure Ulcer Clinical Trials

Extended Prone Position Duration COVID-19-related ARDS: a Retrospective Study

Start date: March 1, 2020
Phase:
Study type: Observational

Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

NCT ID: NCT05123417 Completed - Pressure Ulcer Clinical Trials

Knowledge and Practices of Preventing Pressure Ulcers

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

Pressure ulcer is defined by the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) as "localized skin and/or skin, usually arising over bony prominences, caused by pressure alone, or by a combination of shear and pressure. subcutaneous tissue damage. Pressure ulcer is a painful, costly and preventable health problem that is frequently encountered especially in geriatrics group and in patients with limited daily activities or bedridden. It is an undesirable health care problem that is difficult to treat, but it is possible to prevent the development of pressure ulcers with the measures to be taken from the beginning of the disease. In order for nurses to fulfill their role in preventing pressure ulcers, the content of undergraduate education programs needs to be arranged in a way that will provide them with knowledge and skills in the prevention of pressure ulcers, diagnosis of risky patients and maintenance of care. In Northern Cyprus, knowledge and skills related to pressure sores are provided to students in the basic nursing education curriculum. However, the subject of pressure ulcer in the education programs of nursing schools differs in terms of content and duration, and most of the hospitals do not have a standard guide and training program for the prevention of pressure ulcers. In Northern Cyprus, studies on the knowledge and practices of nursing students to prevent pressure ulcers are limited. According to the results of a study conducted in Turkey, it has been reported that a significant portion of nursing students have a positive attitude towards preventing pressure ulcers, but their general knowledge about preventing pressure ulcers is insufficient. In another study, it was reported that 70.7% of nursing students encountered patients with pressure ulcers during hospital practices, but research findings and the knowledge of nursing students to prevent the development of pressure ulcers were insufficient. Similarly, in studies conducted with nursing students using different scales, it has been reported that students' knowledge levels about preventing pressure ulcers are low. This research was planned in accordance with the randomized controlled research method in order to determine the knowledge levels and practices of firts year nursing students to prevent pressure ulcers.

NCT ID: NCT05112679 Completed - Amputation Clinical Trials

Limb Health and Socket Pressure in Response to Powered Ankle Protheses

OPORP
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.