Track topics on Twitter Track topics that are important to you
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons.
Chronic ulcers affect millions of people, and are a growing clinical problem seen most frequently in the elderly. Non-healing or slow healing wounds represent a major health burden and drain on resources, contributing to substantial disability, morbidity, and cost. Wound healing involves a well-orchestrated, complex process leading to repair of injured tissues. Basic principles of good wound care involve removal of necrotic tissue by mechanical, surgical or enzymatic debridement, wound bed preparation, and treatment of infection. In general, wounds that are being appropriately managed show measurable progress within 2-4 weeks. However despite delivering good wound care that includes providing the right dressings, nutritional support, topical care, and offering top-of-the-line support surfaces, wounds often become stagnated. Wounds refractory to treatment for 2-4 weeks are dubbed recalcitrant. Such wounds need sometime some stimuli to start the healing cascade. Polyheal-1, is thought do be potentially useful in triggering the healing process and can be particularly beneficial in stimulating the granulation process in chronic wounds of different etiologies e.g. venous, diabetic wounds, decubitus ulcers and post trauma/surgery complicated wounds. For instance exposed bones and tendons that are particularly difficult to be treated, were previously demonstrated to benefit from stimulation of granulation coverage by application of Polyheal 1.
In this protocol we intent to perform comparative study aimed at comparing performance of Polyheal I to Saline in treatment of recalcitrant wounds of different etiology such as venous and various post-operative wounds including cases were the exposed bone needs granulation coverage. Furthermore, patients with post- operative surgical complications such as sternum or partial foot amputation in diabetic patients will also be a subject of present investigation. Polyheal 1 will be compared to saline as this is the most commonly used treatment intended at keeping the wound moist and enabling progress of granulation and epithelization.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Wounds and Injuries
Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
Soroka University Medical Center
Published on BioPortfolio: 2014-08-27T03:35:18-0400
evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia
The study is designed to evaluate the efficacy and safety of intravenous infusion of hypertonic saline in BPH patients, candidates for TURP surgery using the monopolar electric resectoscop...
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also ...
Aim of the study: Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model. Clinical relevance: - Accelerated h...
The aim of this study is to establish a contamination-free milling method using ice beads instead of conventional hard beads such as metal or ceramics. Ice beads, which melt after the milling process ...
The practice of marking gunshot wounds and obtaining X-rays (XRs) has been performed to determine the trajectory of missiles to help identify internal injuries. We hypothesized that surgeons would hav...
Fixed-bed reactor (FBR) is a promising technology for realising robust high-rate nitrification. Only a few studies have investigated the effect of salinity on these systems. In this research work, the...
The objectives of this study were to evaluate the impact of formulation variables on the drying of nanocrystalline suspensions either via bead layering or spray granulation and develop mini-tablets fr...
Pressure injury is one of the most prevalent skin injuries and a great challenge in the hospital environment. The implementation of preventive measures contributes to reducing its occurrence.
Head injuries which feature compromise of the skull and dura mater. These may result from gunshot wounds (WOUNDS, GUNSHOT), stab wounds (WOUNDS, STAB), and other forms of trauma.
WOUNDS and INJURIES and PSYCHOLOGICAL TRAUMA sustained during WAR.
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Penetrating stab wounds caused by needles. They are of special concern to health care workers since such injuries put them at risk for developing infectious disease.
Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...