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Pressure Ulcer clinical trials

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NCT ID: NCT06294327 Recruiting - Pressure Ulcer Clinical Trials

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

Start date: January 22, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06283979 Not yet recruiting - Osteomyelitis Clinical Trials

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

BLADE OPU2
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

NCT ID: NCT06270264 Completed - Pressure Ulcer Clinical Trials

Nociception Monitoring in Intensive Care

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care.

NCT ID: NCT06243328 Not yet recruiting - Pressure Sores Clinical Trials

Effect of Negative Wound Pressure on P.S

Start date: February 2024
Phase: N/A
Study type: Interventional

This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue

NCT ID: NCT06219954 Recruiting - Pressure Ulcer Clinical Trials

Prevention of Pressure Wound Development With Infrared Thermal Camera

Start date: January 3, 2024
Phase:
Study type: Observational

Pressure wound (PW) is generally defined as localized damage to the skin and subcutaneous soft tissue on a bone protrusion or caused by medical devices. Although it is a preventable complication and one of the quality indicators for healthcare institutions, the prevalence of PW is high.Up to 95% of pressure wounds are preventable, but pressure wounds are only detected when sores become visible. Infrared thermography is used in the physiological and anatomical assessment of skin and subcutaneous tissue abnormalities and in detecting pressure injuries by measuring temperature changes caused by circulatory problems.The aim of the researchers is to compare the development of PW in patients admitted to intensive care by imaging the skin temperature in pressure areas using the traditional method and an infrared camera.

NCT ID: NCT06183086 Recruiting - Pressure Ulcer Clinical Trials

PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries

TRELINOIL
Start date: November 14, 2023
Phase:
Study type: Observational

To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.

NCT ID: NCT06166641 Recruiting - Pressure Ulcer Clinical Trials

Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients

Start date: August 1, 2023
Phase:
Study type: Observational

The study aims to effectively identify the risk of intraoperative acquired pressure injuries (IAPI) in surgical patients through a prospective multicenter approach. It combines indicators from commonly used assessment tools and practical experience judgments to construct a comprehensive assessment framework. By incorporating various indicators, the study aims to improve the accuracy and reliability of identifying patients at risk of IAPI during surgery. This will help clinicians in making informed decisions and implementing preventive measures to minimize the occurrence of pressure injuries. The multicenter approach ensures a diverse and representative sample of patients from different surgical settings. This increases the generalizability of the study findings and enhances the applicability of the assessment framework across various clinical settings. The project's methodology involves collecting data on patient demographics, medical history, surgical procedure details, and assessment tool scores. These data points will be analyzed to identify significant risk factors for IAPI and develop a risk prediction model. The study also takes into consideration practical experience judgments, which acknowledge the importance of clinical expertise in assessing patients' risk of IAPI. This ensures that the assessment framework is not solely reliant on assessment tools but also incorporates the insights of experienced clinicians. Overall, this prospective multicenter study aims to contribute to the field by providing a comprehensive and practical approach to identify the risk of IAPI in surgical patients. The findings from this study can be utilized in clinical practice to improve patient outcomes and reduce the incidence of pressure injuries during surgery.

NCT ID: NCT06163352 Completed - Pressure Ulcer Clinical Trials

The Effect of Vasopressor on Pressure Injury Development

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Background: Vasopressors are life-saving agents that increase mean arterial pressure. The pharmacodynamic features of these agents and previous studies suggest that vasopressors may be an essential risk factor in developing pressure injuries. Objective: This study aimed to examine the effect of vasopressors in medical-surgical intensive care patients on pressure injury development. Design and Settings: This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 148 surgical and medical patients treated with vasopressor agents in the intensive care unit. Data on patients' demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). A logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.

NCT ID: NCT06151769 Not yet recruiting - Pressure Ulcer Clinical Trials

The Effect Pomegranate Seed Oil Prevention and Progression Pressure Ulcers in Intensive Care Patients

Start date: February 18, 2024
Phase: N/A
Study type: Interventional

Pressure sores are an important health problem that can be seen at any age and in any environment where care is provided, especially in intensive care units. It is a problem that can frequently develop, especially in people who are bedridden for long periods of time and who have acute or chronic diseases. While the incidence of pressure ulcers in hospitals is 10-23%, this rate has been reported to be 8.1%-41% in intensive care units. In Turkey, the incidence of pressure ulcers in patients receiving mechanical ventilation treatment for at least 24 hours was found to be 17% and 15.5% in intensive care units. It is an important problem that requires long-term care and treatment after the development of a pressure sore, prolongs the duration of hospitalization, has high treatment and care costs, and increases morbidity. In a systematic review, it was stated that pressure ulcer treatment, in addition to normal treatment, increased the per capita cost of care between € 2.65 and € 87.57 per day.The care provided due to developing pressure sores increases the burden on healthcare professionals and makes it difficult to achieve the desired quality of care.It also brings an extra financial burden to care institutions.Studies have found that pressure ulcer development increases the cost of nursing care. Pressure sores also cause pain, infection, etc. in patients. It leads to the development of serious problems, deterioration in comfort and a significant decrease in the quality of life. The use of complementary medicines, including medicinal plants, has long been recommended in this regard. The latest approaches in medicine recommend its use in the prevention and treatment of diseases due to its fewer side effects, and it is welcomed by patients. Assessment and care of the skin is important in preventing pressure sores. Pomegranate seed oil is very rich in conjugated fatty acids (linoleic and linolenic fatty acids). Although the effectiveness of pomegranate seed oil has been investigated in many subjects, there is no study examining its effectiveness in preventing and healing wound development. The aim of this study is to determine the application of topical pomegranate seed oil. To examine its effect on pressure sore development and progression. To determine the effect of topical pomegranate seed application on the prevention and progression of pressure sores. It will be conducted as a randomized controlled experimental study.

NCT ID: NCT06128005 Recruiting - Pressure Ulcer Clinical Trials

Pressure Injury、Caregiver、Knowledge Translation

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Background and importance: In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Nowadays, it still constantly happens at hospitals, home, and nursing homes: Pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. In current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. Therefore, the caregivers are more passive, and feel nervous and confused. In literature, there are guidelines for pressure injury prevention and management. However, they are primarily designed for heath professionals. As a result, to achieve evidence-based practice and knowledge translation, I hope to make individual management plans for each patient, provide caring support, and follow up with patients. And caregivers can benefit from knowledge, attitude, practice, and caring effect.