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Pressure Ulcer clinical trials

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NCT ID: NCT06468306 Not yet recruiting - Clinical trials for Inflammatory Response

Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

Start date: August 1, 2024
Phase:
Study type: Observational

This project aims to develop a novel method for identifying early tissue damage related to pressure ulcer (PU) development in vulnerable patients by measuring biomarkers of inflammation on the skin surface. PUs are common and costly injuries that result from prolonged pressure on the skin. Current methods to assess PU risk are unreliable, and the mechanisms of PU development are not well understood. This project contributes to new knowledge of PU etiology as well as the individual variability at a molecular level combined with new knowledge about nursing actions and clinical factors linked to PU progression and outcomes of prevention. The project will use non-invasive techniques and model-based analysis to identify specific biomolecules that reflect individual susceptibility to pressure exposure in different PU risk scenarios.

NCT ID: NCT06465225 Not yet recruiting - Pressure Ulcer Clinical Trials

Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress

PRESERVE
Start date: July 1, 2024
Phase:
Study type: Observational

The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay 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 between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients will be 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 will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

NCT ID: NCT06457555 Not yet recruiting - Pressure Ulcer Clinical Trials

Knowledge Levels and Experiences of Intensive Care Nurses on the Prevention of Pressure Sores: Mixed Method

Start date: July 1, 2024
Phase:
Study type: Observational

This research aims to determine the knowledge levels and practices of intensive care nurses regarding the prevention of pressure sores. The main questions it aims to answer are: 1. What is the level of knowledge of intensive care nurses regarding the prevention of pressure sores? 2. What is the impact of sociodemographic characteristics of intensive care nurses on their knowledge level regarding the prevention of pressure sores? 3. What are the experiences of intensive care nurses regarding their practices for the prevention of pressure sores? In this research, a survey and interview technique will be applied to determine the knowledge levels and experiences of nurses working in adult intensive care units regarding the prevention of pressure sores and their practices.

NCT ID: NCT06442657 Not yet recruiting - Clinical trials for Pressure Ulcers Prevention in Prone Positioning in Intensive Care

Pressure Sore Prevention Strategy for the Prone Position

DERM-H-PROTECT
Start date: June 18, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. The main questions it aims to answer are: - are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? The researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position. Participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.

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: NCT06421454 Not yet recruiting - Pressure Ulcer Clinical Trials

Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

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

Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.

NCT ID: NCT06384183 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Kerecis Real World Registry

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

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: NCT06330506 Not yet recruiting - Pressure Ulcer Clinical Trials

The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.

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.