View clinical trials related to Pressure Ulcer.
Filter by:Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of hospitalization that have serious consequences on patient morbidity and mortality as well as the cost of care. At the core of the problem for patient-centered targeted prevention of HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary to cause pressure ulcers, and the lack of immediate feedback on whether these interventions do anything to substantially offload at risk areas. Previous studies have been inconsistent in their findings of an association between duration of time and HAPU occurrence. While retrospectively this has been investigated, there is currently no substantial prospective, randomized study. This study seeks to better understand the interface pressures between the patient and his or her support surface and how this relates to the development of pressure ulcers. The effect of patient characteristics and the relationship between total length of time on the operating table and pressure ulcer development will also be assessed. The findings from this study will significantly add to strengthening the body of evidence regarding pressure ulcer development, specifically the relationship between the magnitude of interface pressure between the patient and the support surface for what duration of time leads to the development of a pressure ulcer. The results will provide critical insight into the physiologic targets healthcare providers should use to develop better pressure ulcer prevention programs, which could ultimately lead to a reduction in the incidence of pressure ulcers.
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.
Objective - To demonstrate the efficacy of the pressure redistributing cooling mattress overlay compared to usual care in mitigating the progression of early pressure ulcers in critically ill (ICU) patients via a prospective randomized human clinical trial. Specific Aim - The clinical trial will evaluate the efficacy and safety of the PRO-TECT ™ mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1 and 2) and preventing further progression to more severe pressure ulcers (Stage 3 and 4) as well as potential faster regression (i.e. healing of Stage 1 and 2 pressures).
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain. There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc. The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.
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.
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. PUs and other skin breakdowns are at risk for becoming infected; it is not uncommon for many different types of "bugs" to be found in the wound. It has been assumed that the presence of these organisms did not impede wound healing or skin graft survival. The current proposal will use a new type of procedure that involves the direct injection of an antibiotic (in saline) into the skin beneath the wound; it is then distributed throughout the wound using a second device that uses sound waves. The study will determine if the antibiotic treatment and the standard of care improves the rate wound closure compared to the standard of care alone in persons with SCI and a chronic pelvic-region PU.
Development of pressure ulcer (PU) is complex and multifactorial. The association of a constituted PU and of clinical / biological major elements is demonstrated and justifies. Prevention of PU is an important health priority, one that requires clear identification of risk factors.
This prospective pilot study is to enroll patients with clinically-defined infected wounds. Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients will be recruited for this study in Phase A. Based on the expectation that 89% of these wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the study for Phase B.
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge.
Study purpose: To assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital PU