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29 active trials for Pressure Ulcer

PLASOMA Ultimate Safety & Efficacy Study

The purpose of the PULSE study is to perform post market clinical follow up (PMCF) on safety and efficacy: Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: FU1: 2 weeks after end treatment period FU2: 12 weeks after end treatment period FU3: 12 months after start treatment.

Start: May 2021

Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery

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

Start: March 2019

CMAP Refinement for Pressure Injury Prevention

For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being. Pressure injuries are costly to treat, negatively impact quality of life and community participation, and can be life threatening. Moving or shifting at regular intervals in the wheelchair redistributes harmful pressure and reduce risk for skin breakdown, yet these movements are a challenge to perform consistently. The challenge exists due to lack of sensation to let the individual know they need to shift their weight. Pressure mapping provides a detailed visual representation of pressure distribution and can compensate for impaired sensation. Pressure mapping feedback delivered on-demand on mobile platforms can potentially increase effectiveness in carrying out behaviors to reduce risk for pressure injury when used during clinician-delivered education to set goals and monitor progress and when used at home as a self-management strategy.

Start: June 2020

An RCT on Support Surfaces for Pressure Ulcer Prevention

Pressure injuries are a serious health care problem and affect millions of people. Most pressure injuries are avoidable with the application of best practices and with the use of appropriate technology. Support surfaces are a crucial component of any comprehensive prevention strategy. Decades of research have produced moderate and low levels of evidence upon which to base clinical decisions concerning how and when to apply support surfaces for prevention. This knowledge has been periodically assessed and assembled into clinical practice guidelines. There is good evidence that the combined group of active and reactive support surfaces is effective in preventing pressure injuries and that high-specification reactive foam surfaces are effective in preventing pressure injuries. But there is insufficient evidence that low air loss surfaces are more or less effective than other types of surfaces. Yet, low air loss surfaces are used for more than 17% of patients in acute care at high risk of developing pressure injuries. The study is designed to determine if and when low air loss is effective in preventing pressure injuries, and what level of heat and moisture control performance is necessary for prevention effectiveness. The primary aim of the project is to compare the effectiveness of reactive support surfaces with low air loss to reactive support surfaces without low air loss in preventing pressure injuries for people with moisture risk factors in acute care. Support surfaces are currently marketed and identified by practitioners based on device features (e.g., low air loss, air fluidization, alternating pressure), categories (powered, non-powered, reactive, and active) and components (e.g., foam, gel, fluid). The critical performance characteristics of low air loss systems are moisture, humidity and temperature management. Preliminary work has revealed that these characteristics vary widely among different low air loss products. A secondary aim of the proposed study is to explore associations between support surface performance characteristics and pressure injury outcomes to identify which low air loss performance characteristics and what level of those performance characteristics are necessary for the technology to be effective. Successful completion of this project will fill a critical gap in evidence regarding the effectiveness of support surfaces with low air loss, and could influence a shift in the way support surfaces are characterized away from the current feature-based paradigm toward a more clinically relevant and generalizable performance-based paradigm.

Start: September 2018

Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt

the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt

Start: May 2021

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers

To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).

Start: January 2021

Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species. This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

Start: September 2021

Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care

Peripheral venous catheterisation is a multi-daily practice in a paediatric ward. In our pediatrics department, nurses have observed for several years now the appearance of pressure sore-like skin lesions at the junction of the peripheral venous catheter with the extension tube. A ward habit has spontaneously developed of applying a compress under this junction. The objective is to minimize physical or emotional aggression as well as pain. Pain that is denied or not identified and not relieved is memorized by the child, which can have consequences on the perception of pain and the subsequent acceptance of care. To date, through their reading and research, investigators have been able to find articles mentioning the risks of pressure ulcers in children related to medical devices. However, few elements are developed concerning catheter-related pressure ulcers, especially on this specific technique for preventing injuries at the catheter-extension tube junction. Investigators have not found any recommendations on this subject. Thus, the aim of this study is to compare two peripheral venous catheter fixation devices, with compress and without compress, and to analyse the frequency of pressure ulcer occurrence and the intensity of this lesion.

Start: September 2020

Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy

A Multi-center, Prospective Clinical Trial Evaluating the Combination of BlastX and Negative Pressure Wound Therapy (VAC).To evaluate the 4-week healing trajectory/wound area reduction with BlastX/VAC as compared with historical pre-study 4-week healing trajectory data and data from the US Wound Registry.

Start: October 2019

Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers

This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer or diabetic foot ulcers. Patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.

Start: July 2015

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

Start: April 2021

Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota

Participants will be randomly assigned to the experimental group where they will be given enteral nutrition formula rich in zinc and arginine plus a symbiotic (Probinul- Ca.Di.GROUP S.r.l.) once a day for 90 days or the control group where they will receive only the enteral nutrition formula rich in zinc and arginine.

Start: June 2017

Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries. Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension. The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.

Start: August 2020

A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System

The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

Start: December 2020

Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Patient positioning is an essential part of a preventive strategy for neurocritical care patients. The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.

Start: January 2020

Efficacy of Wound Dressings With Copper Oxide

Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.

Start: November 2020

DETEC® Esterase for Screening Wound Infection at Point of Care

This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by measuring wound exudates-soaked wound dressings using the DETEC® Esterase device during routine wound care. The output of the device is correlated with the clinical determination of infection to assess the device efficacy in identifying presumptive infections.

Start: November 2020

DETEC® pH Point of Care Wound Diagnostic Test

The purpose of this study is to determine the relationship between wound alkalinity and non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care

Start: November 2020

Novel Support Surface to Alleviate Pressure Ulcer

A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.

Start: September 2020

Evaluation of Wheelchair In-Seat Activity Tracker

Individuals who use wheelchairs are at an increased risk of developing pressure injuries on the parts of the body that are in constant contact with the wheelchair. The development of pressure injuries can cause reduced mobility, reduced activity and participation, greater unemployment, increased risk for future pressure injury development, and premature death. There are numerous risk factors associated with developing pressure injuries. Individuals can reduce the risk of pressure injury formation by changing positions, weight-shifting, and using special cushions, but many people still struggle with pressure injuries. This study is designed to assess the clinical effectiveness of WiSAT (Wheelchair in-Seat Activity Tracker). WiSAT is a tool designed to help prevent the development of pressure ulcers by changing behaviors that can lead to pressure ulcers. WiSAT monitors and provides real-time feedback on weight shifts and pressure relief behaviors while sitting in a wheelchair.

Start: January 2020