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Wounds and Injuries clinical trials

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NCT ID: NCT02467998 Recruiting - Burns Clinical Trials

Negative Pressure Wound Therapy Registry

NPWTR
Start date: January 2005
Phase:
Study type: Observational [Patient Registry]

The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the effectiveness and safety of various NPWT devices and methods among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.

NCT ID: NCT02465242 Recruiting - Clinical trials for Traumatic Brain Injury

Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury

Start date: September 2014
Phase: N/A
Study type: Observational

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC states that 1.7 million people sustain a traumatic brain injury each year, with death occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly require hospitalization. The costs of TBI can be devastating to our society, with the 2010 economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have high rates of institutionalization, readmission, and disability. The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis evaluation in the acute phase of care varies widely among physicians caring for these patients[3]. With prognosis often in doubt, physicians have difficulty leading families and patients toward the most appropriate treatment which often leads to expensive testing and patient management. The Brain Trauma Foundation has recommended several early indicators of prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have been extensively studied, however accurate measurements of these prognostic factors have not been performed due to a lack of standardized measuring procedure. A new device has been validated to measure both pupil size and reactivity using infrared pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi) as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial pressure readings, however there are no studies correlating the pupillometer findings with outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable predictor of 30-day outcomes in patients with severe TBI.

NCT ID: NCT02451683 Recruiting - Spinal Cord Injury Clinical Trials

Corticospinal Function After Spinal Cord Injury

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.

NCT ID: NCT02446210 Recruiting - Spinal Cord Injury Clinical Trials

Neuroplasticity After Spinal Cord Injury

Start date: January 28, 2021
Phase: N/A
Study type: Interventional

The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.

NCT ID: NCT02426255 Recruiting - Clinical trials for Severe Trauma (With or Without Traumatic Brain Injury)

Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)

Start date: March 29, 2013
Phase:
Study type: Observational

The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

NCT ID: NCT02421081 Recruiting - Clinical trials for Injury; Ulnar Artery, Hand and Wrist

Effect of Cell Surface Markers and Lymphoid Cell Distribution on the Arterial Tissue Repair (ECLAR)

ECLAR
Start date: August 2014
Phase: N/A
Study type: Interventional

The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Recently has begun to focus on neointimal thickening and endothelialization of the role in vascular healing and maturation made on histopathological study. In this study, the radial and ulnar artery laceration repair healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the effect of the distribution of lymphoid cells has been investigated. The investigators think that; thus by demonstrating the positive impact that may arise; autologous endothelial progenitor cells which are obtained in patients; continuation of anastomotic patency undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The investigators believe could be used for the reimplanted tissue in the limb breakage ensuring that survive.

NCT ID: NCT02407028 Recruiting - Clinical trials for Traumatic Brain Injury

Hyperbaric Oxygen Brain Injury Treatment Trial

HOBIT
Start date: June 25, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

NCT ID: NCT02395497 Recruiting - Amputation Clinical Trials

Human Penile Allotransplantation

Start date: June 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.

NCT ID: NCT02375854 Recruiting - Clinical trials for Chronic Kidney Disease

Outcomes of Neonatal Acute Kidney Injury In Premature Infants

Start date: November 2014
Phase:
Study type: Observational [Patient Registry]

The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.

NCT ID: NCT02367768 Recruiting - Wounds and Injuries Clinical Trials

Long-term Outcome Related Prognostic Factor and Biomarkers of Major Trauma Database Analysis

Start date: February 2015
Phase: N/A
Study type: Observational

The investigators were looking for resuscitation management, trauma mechanism, risk factors, and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma patients besides injury severity score (ISS) guiding the traumatologist. The medicare resource could be utilized efficiently along with increasing in the survival and quality of lifer (QoL) in major trauma.