Active clinical trials for "Pressure Ulcer"

The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied. Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300 Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds. Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds. Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors.

Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

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.

A double blind, non randomized, multicenter investigation

This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive measures which consist in the use of three different medical devices.

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.

The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP) overlay could be beneficial to preventing skin damage during daily activities, such as lying in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used to increase skin tolerance when lying in bed for an extended period of time (40 minutes), including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen and nutrients to skin) as compared to regular operation room (OR) overlay. A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo study procedures including: AP and Control protocols. Skin blood flow and interface pressure will be collected non-invasively (from outside the body) during both protocols. During AP protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol, subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side (10 min). Subject will then proceed to vascular control measures, including: non-invasive skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation. Findings from this study will help us understand the effectiveness of the AP overlay on skin blood flow response during prolonged lying in bed.

This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes

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.