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Pressure Ulcers clinical trials

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NCT ID: NCT06374563 Completed - Pressure Ulcers Clinical Trials

Tackling Pressure Ulcer Via Bee Venom Phonophoresis

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

This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer

NCT ID: NCT03823963 Recruiting - Prevention Clinical Trials

Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

MEPICARD
Start date: December 10, 2018
Phase: Phase 4
Study type: Interventional

The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital. Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

NCT ID: NCT03454230 Completed - Pressure Injury Clinical Trials

Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care.

PROMESReaPilot
Start date: March 5, 2018
Phase: N/A
Study type: Interventional

Pressure ulcers (PU) represent a major health issue because of their high incidence and of their important consequences. There is an important risk of pressure ulcer acquisition for ICU patient with acute organ failure. Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors. A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown. Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).

NCT ID: NCT03070925 Completed - Pressure Ulcers Clinical Trials

Prospective PuraPly™ AM Case Series Study

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

The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

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: 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: NCT02701101 Completed - Pressure Ulcers Clinical Trials

Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study

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

This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before clinical judgment using signs of pressure ulcers from skin assessments. longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before skin assessments.

NCT ID: NCT02690753 Completed - Pressure Ulcers Clinical Trials

Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

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

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources. The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed. The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.

NCT ID: NCT02689310 Withdrawn - Pressure Ulcers Clinical Trials

Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care. Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. Moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment. Therefore, the investigators specific study objectives are as follows: 1. Primary Objectives: Determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. Specifically, the investigators will monitor patient PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the Wong Baker Face or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.). 2. Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.

NCT ID: NCT02585765 Withdrawn - Spinal Cord Injury Clinical Trials

Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI

Start date: February 1, 2017
Phase: Phase 2
Study type: Interventional

Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant negative effect on skin blood flow. In addition, improper management of blood sugar is a major risk factor for PU development and it impedes healing. It would appear that hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that target the blood vessels may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the lower extremity were shown to be much lower than healthy individuals. The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic region PU has 2 phases: (1) a 4-week "observation" phase [if the PU does not heal appropriately (determined by digital photos and software computation), and the subject is found to be insulin resistant then they will progress to the next phase of the study] and (2) an 8-week "treatment" phase. All participants will continue to receive the standard wound care throughout the observation and treatment phases. If the surface area of the PU does not decrease by more than 30% during the 4-week observation phase, the participant will be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to receive active drug (e.g., pioglitazone) or placebo. The participants will have four study visits in which the following will be acquired: digital image of the wound to monitor wound surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional status (albumin and pre-albumin), a complete blood count with differential, and makers of inflammation. Weekly monitoring of symptoms and participant experiences will be closely monitored.