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Pressure Ulcer clinical trials

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NCT ID: NCT03010293 Completed - Clinical trials for Bone Diseases, Infectious

Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy

Start date: June 2016
Phase: N/A
Study type: Observational

Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.

NCT ID: NCT02996331 Completed - Pressure Ulcer Clinical Trials

Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors

Start date: May 16, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether repositioning frequency can be extended for nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU) development. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

NCT ID: NCT02969343 Completed - Clinical trials for Venous Thromboembolism

Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered

PSLL
Start date: April 2015
Phase: N/A
Study type: Interventional

The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.

NCT ID: NCT02952664 Completed - Pressure Ulcer Clinical Trials

Pressure Ulcer Monitoring Platform (PUMP)

PUMP
Start date: January 2017
Phase: N/A
Study type: Interventional

This study will employ two monitoring device prototypes. The devices are sensors containing accelerometers and gyroscope. The raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. The data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. One sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.

NCT ID: NCT02930590 Completed - Pressure Ulcers Clinical Trials

Effects of Different Support Surfaces on the Properties Skin After Loading

Start date: September 2016
Phase: N/A
Study type: Interventional

Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).

NCT ID: NCT02925741 Completed - Pressure Ulcer Clinical Trials

Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers

Start date: March 2014
Phase: N/A
Study type: Interventional

This study will use a traditional parallel randomization design with patients in five medical intensive care units at the Cleveland Clinic to evaluate the efficacy of silk-like bed sheets and underpads for prevention of Unit-Acquired Pressure Ulcers (UAPU). Adult hospitalized patients in beds with standard bed linens versus those with silk-like linens will be compared for 1) rate of development of UAPU, 2) time to develop the first UAPU, and the maximum severity of any UAPU that develop. Bed linens will be changed per unit protocol. Patient characteristics will be summarized using frequencies and percentages for categorical factors and means, standard deviations, percentiles and median and range for continuous measures. For the primary outcome of unit-acquired pressure ulcer rate, generalized linear mixed models, assuming a Poisson distribution for the outcome, and unit length of stay as an offset will be used. For the time to event analysis, frailty models will be used to assess whether time to first pressure ulcer differs between treatment types. Generalized linear mixed models will be used for other secondary endpoints, including maximum severity of observed pressure ulcers

NCT ID: NCT02901470 Completed - Pressure Ulcer Clinical Trials

Observational Study of the Incidence of Pressure Ulcers on the Help Support of Prevention of Bedsores POLYAIR®

Start date: February 11, 2015
Phase:
Study type: Observational

The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors

NCT ID: NCT02894437 Completed - Clinical trials for Spinal Cord Injuries

Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord

QUALIPREPS
Start date: November 2015
Phase:
Study type: Observational

The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.

NCT ID: NCT02863263 Terminated - Pressure Ulcer Clinical Trials

Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer

Start date: July 29, 2016
Phase: N/A
Study type: Interventional

This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.

NCT ID: NCT02861560 Completed - Pressure Ulcer Clinical Trials

Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

Start date: May 2016
Phase: N/A
Study type: Interventional

A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers