Active clinical trials for "Wounds and Injuries"

Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. This is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.

This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact. Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters. Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm. The primary outcome measure and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation. Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure. Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project. Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

The purpose of this study was to evaluate prospectively the impact of two protective mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery. The study selected patients presenting signals of deficient gas exchange (PaO2/FIO2 < 250 at a PEEP [positive end expiratory pressure] of 5 cmH2O) in the immediate post-operative period. An aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing period of four hours of controlled mechanical ventilation, the patients followed the routine weaning protocol and physiotherapy protocol of the institution.

This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.

This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and phenylacetylglutamine (PAGN); its effect on circulating ammonia levels and neurological function in patients with and without impaired renal function after continuous infusion at different infusion rates. Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day follow-up visit post infusion. It is anticipated that this early safety and tolerability study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The hypotheses are: Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune hepatitis, viral hepatitis or indeterminate etiologies. A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations within 6-12h with little additional accumulation in the ALI/ALF setting. Treatment with OCR-002 will reduce ammonia and improve neurological function in patients with acute liver failure/severe acute liver injury.

Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.

This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.

As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.

Background: To study intensive targeted cognitive rehabilitation of attention in the acute (<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work). Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with stroke or traumatic brain injury are randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress is evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints include measurement of cognitive functions, activity and work return. There are 3, 6 and 12-month follow ups focussing on health economics. Discussion: The study will provide information on rehabilitation of attention in the early phases after acquired brain injury (ABI); effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation.