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Wounds and Injuries clinical trials

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NCT ID: NCT02892435 Recruiting - Wound Healing Clinical Trials

Prevena™ Incision Management System vs Conventional Management for Wound Healing

Start date: November 2014
Phase: Phase 2
Study type: Interventional

Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

NCT ID: NCT02885714 Recruiting - Clinical trials for Acute Rotator Cuff Tear Related to Trauma

ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma

Start date: December 2016
Phase: N/A
Study type: Interventional

Rotator cuff tear is a very common and disabling condition that can be related to acute trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears, although beneficial results have been reported for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair surgery involves a considerable amount of re-ruptures, and it is possible that the repaired tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also found in completely asymptomatic persons and the clinical significance of a rupture may be generally lower than estimated. The above-mentioned factors, as well as recent research and meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff tear than conservative treatment alone. However, these previous research findings cannot be applied directly to traumatic tears, although degeneration can be considered always to contribute to the creation of a rotator cuff tear. During few last decades, despite the lack of evidence on the superiority of one treatment over another, the use of surgery to treat this disorder has been substantially increased. Treatment expectations are found to be important in predicting patient related outcome measures. In addition, surgery itself may produce a profound placebo effect. There are no previous placebo-controlled trials on the topic of interest. In order to find out the true efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly the supraspinatus tendon, the investigators have designed this multi-centre, randomized, placebo-controlled efficacy trial.

NCT ID: NCT02877342 Recruiting - Major Trauma Clinical Trials

Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India

Start date: March 2016
Phase: N/A
Study type: Observational

A prospective observational study using an interrupted time-series design to evaluate the effect of pre-hospital notification on trauma patients arriving at a trauma centre by ambulance, in India

NCT ID: NCT02861547 Recruiting - Clinical trials for Traumatic Brain Injury

Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.

SCORE TC
Start date: May 2015
Phase: N/A
Study type: Observational

Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. We will subsequently test this score in a prospective validation cohort.

NCT ID: NCT02859792 Recruiting - Spinal Cord Injury Clinical Trials

Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition

RILUSCI
Start date: May 27, 2019
Phase: Phase 2
Study type: Interventional

The study will be conducted in two steps: 1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel 2. Estimation of the probability of response associated to the MED. Each step has a main objective: Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.

NCT ID: NCT02855034 Recruiting - Clinical trials for Traumatic Brain Injury

Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

TCOP100
Start date: May 27, 2016
Phase: N/A
Study type: Interventional

Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin). It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B. Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCHL1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

NCT ID: NCT02814383 Recruiting - Brain Injury Clinical Trials

Prediction of Brain Injury in Premature Infants

Start date: August 11, 2016
Phase:
Study type: Observational

Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidence is inversely proportional to gestational age (GA) and birth weight (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic hemodynamics during transition from intra- to extra-uterine life and during the early neonatal period is believed to be at their genesis. While the incidence of ultrasound- diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity and brain volume and eventual neurocognitive impairment. Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has remained relatively stable. Once translated to the bedside, the goal of this research is to develop a monitoring system that will allow researchers to identify infants most at risk for IVH and PVL and in the future, intervention studies will be initiated to use the changes in cerebral perfusion to direct hemodynamic management. The purpose of this study is to first understand the physiology of brain injury and then to eventually impact the outcomes in this high-risk group of infants by assessing the ability of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for this study will help develop algorithms or monitoring plans that will maintain the appropriate brain perfusion pressure and thereby, prevent severe brain injury.

NCT ID: NCT02810145 Recruiting - Brain Injuries Clinical Trials

Cerebral Desaturation in Traumatic Brain Injury

Start date: July 2016
Phase: N/A
Study type: Observational

We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult patients (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at the Health Sciences Center with a severe TBI will have cerebral oximetry monitoring instituted within 12 hours of admission and continuing for 72 hours after placement. Decreases in regional cerebral oxygenation will be correlated with ICU hemodynamic parameters including mean arterial pressure, intracranial pressure, and arterial oxygen and carbon dioxide tension.

NCT ID: NCT02808078 Recruiting - Stroke Clinical Trials

Gait Adaptation for Stroke Patients With Augmented Reality

GASPAR
Start date: June 2016
Phase: N/A
Study type: Interventional

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

NCT ID: NCT02798042 Recruiting - Obesity Clinical Trials

Does the Presence of Preoperative Proteinuria Predict Postoperative Acute Kidney Injury in Obese Patients Undergoing Elective Laparoscopic Surgery?

Start date: June 16, 2016
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care.