Active clinical trials for "Wounds and Injuries"

Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days after SCI as a clinical option. Unfortunately, the medical evidence to support this recommendation exists only at the clinical case series level (Class III data). Furthermore, maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated with risks to the patient via adverse medical events. Given this equivocal evidence, the investigators group has questioned the merit of sustained induced hypertension following acute SCI and has previously conducted a randomized, prospective controlled feasibility study to further examine this issue. This prior pilot study randomized patients with acute SCI to a spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure was defined as the change in American Spinal Injury Association (ASIA) motor score from baseline. No difference in the primary outcome was noted at one-year post-SCI in this study. In light of this pilot data, the investigators hypothesize that maintenance of normotension (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥ 65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority. Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one grade improvement in ASIA impairment scale, quality of life assessment (as measured by Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline, 72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded. The information gleaned from this trial will provide valuable information for the acute treatment of traumatic SCI and will serve the objective of optimizing current clinical practice and thus maximizing medical and neurological outcome for individuals following acute traumatic SCI.

To investigate whether Betadine can reduce infection rates and recurrence rates following varicose veins surgery in a randomized double blind placebo controlled study.

This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.

The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI). Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.

The principle objective of this research is to more precisely determine the degree of benefit that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury. The study has eight* components. Seven involve the evaluation of established radionecrosis at varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The eighth will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax against late radiation tissue injury. *(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment. This decision was based on an interim statistical analysis which generated sufficient evidence to support closing down this arm of HORTIS.)

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.

The investigators propose to compare plasma protein profiles for SCI patients with/without chronic neuropathic pain in order identify biomarker(s) that are associated with this medical condition. Secondly, the investigators propose to identify a temporal relationship to initial SCI at which these biomarkers manifest. Our working hypothesis is that sustained alterations in specific inflammatory molecules are associated with chronic neuropathic pain following SCI, and that their plasma levels can serve as biomarkers to identify patients at risk for the development of neuropathic pain. Additionally the investigators are collecting skin tissue biopsy samples from patients following acute and chronic spinal cord injury to create vector-free human iPS cells from fibroblasts by direct delivery of reprogramming proteins.

Cervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Non-penetrating injuries are the most frequent and can be classified according to the mechanism involved. Whiplash is the most common type of trauma in emergency medicine. The injuries associated with this type of trauma predominate in the mobile spinal segment and are most often benign: only 2 to 3% of conscious patients consulting the emergency room actually present with cervical injuries such as fractures, dislocations or unstable sprains. In emergency medicine, the paradigm is therefore to identify patients at risk of complications, minimizing the need for unnecessary and radiating imaging. Although cervical spine trauma is a frequent reason for emergency room visits, the incidence of anatomical lesions is generally low and the X-rays prescribed most often do not show any abnormality. For cervical lesion screening to be safe and effective, the screening rules must have a high sensitivity, a low negative likelihood ratio, and a low false positive rate. Two clinical prediction rules have been extensively evaluated in the literature to guide imaging for nonpenetrating cervical injuries: the National Emergency X-Radiography Utilization Study (NEXUS) rule and the Canadian C-Spine 5 rule. The NEXUS rule4 applies to any clinically stable patient (Glasgow Coma Scale 15, systolic blood pressure ≥ 90 mmHg, and respiratory rate between 10 and 24/min) presenting to the emergency department with a nonpenetrating trauma. The criteria constituting the NEXUS clinical rule are: Absence of tenderness on palpation of the posterior cervical midline ; Normal state of alertness (Glasgow Coma Scale 15); Absence of focal neurological deficit; Absence of signs of intoxication; Absence of distracting pain (other pain that may mask neck pain, e.g., long bone fracture). If these 5 criteria are present, the risk of cervical spine injury is low and no imaging is recommended. The Canadian C-Spine 5 rule applies to patients who are 16 years of age or older; conscious with a Glasgow Coma Scale of 15; stable (systolic blood pressure ≥ 90 mmHg and respiratory rate between 10 and 24/min); and have had head or neck trauma in the past 48 hours. As soon as the rules of clinical prediction do not make it possible to rule out the hypothesis of a spinal injury, the exploration of cervical trauma traditionally involves the performance of radiographic images. They must include the following incidences: face, profile and open mouth centered on the cervico-occipital hinge ("open mouth odontoid"). Nevertheless, the sensitivity of these conventional radiographs for the detection of cervical spine lesions is poor, about 50%. Thus, the use of standard radiographs is usually limited to conscious, ambulatory patients at low risk of spinal injury. Conversely, the cervical CT is the reference examination for the detection of spinal bone lesions with a sensitivity close to 100%. Its sensitivity is superior to that of radiographic images in both high-risk and low-risk patients with spinal injuries. Difficulty of access and exposure to ionizing radiation, which is lower with standard radiography, generally influence the choice of imaging in the emergency room. In December 2020, the French High Authority for Health published a sheet on the relevance of cervical imaging in the context of non-penetrating cervical trauma. This sheet proposes a practical table according to the precise clinical context of the patient as well as the best first-line imaging. These good practice recommendations were part of an approach to improve the relevance of care. Cervical spine imaging for patients admitted to the emergency department for non-penetrating cervical spine trauma was recommended in one of the following situations patient 65 years of age or older ; patient unstable or with consciousness disorders or neurological signs; imaging recommended by one of the following two rules: NEXUS or Canadian C-Spine; a history of ankylosing spine (ankylosing spondylitis, hyperostosis, etc.), even in case of "minor" trauma; if a cervical artery dissection is suspected. Investigator's hypothesis is that the HAS recommendations of good cervical imaging practices for non-penetrating cervical trauma are difficult to apply routinely in emergency departments for several reasons: the frequency of consultations for cervical trauma, the limited availability of emergency CT scans, and the fear of radiation and unnecessary additional costs in emergency situations. Investigators wish to determine the actual rate of application of the clinical rules recommended by the HAS in the GHPSJ emergency department and the factors predicting their non-application by the GHPSJ team of emergency physicians.

Following brain injury, complex interactions between the nervous system and other organs are frequently encountered. Systemic effects may be induced by dysregulation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. This observational study will investigate the link between clinical, physiological and biochemical expressions of dysautonomic reactions and physiological stress, and their relations to sympathetic activation in traumatic brain injury patients treated in the neurointensive care unit.