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Wounds and Injuries clinical trials

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NCT ID: NCT02931474 Withdrawn - Clinical trials for Traumatic Brain Injury

Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

Start date: October 6, 2016
Phase: Phase 2
Study type: Interventional

Background: People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI. Objective: To see if GHRH can improve sleep in people who have had a TBI. Eligibility: Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube) Interview about their mood and alcohol and drug use Questionnaires about their TBI, mood, and sleep Participants will have 2 overnight study visits a couple weeks apart. These will include: Physical exam Urine sample Two intravenous catheters placed. Blood samples will be taken throughout the night. Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other. Spending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp. A questionnaire in the morning about their sleep Participants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.

NCT ID: NCT02911675 Withdrawn - Clinical trials for Traumatic Brain Injury

Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury

Dual ICP
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of elevated ICP is strongly associated with poor long term patient outcome. Currently, there are two invasive techniques that are used at our facility for monitoring ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP continuously. The second method requires placement of an extracranial ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open. While clinical practices vary greatly across institutions, current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement, a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline. Due to the strong association between poor patient outcome and elevated ICP, this finding is alarming. These findings have important implications for procedures to not only treat elevated ICP, but also prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to prospectively investigate the association between EVD clamping and elevated ICP. Specifically, this study has 2 main objectives: 1. Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping. 2. Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.

NCT ID: NCT02883010 Withdrawn - Wounds and Injuries Clinical Trials

Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery

Start date: January 2017
Phase: N/A
Study type: Interventional

Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.

NCT ID: NCT02861612 Withdrawn - Clinical trials for Spinal Cord Injuries

Nerve Transfers to Restore Hand Function in Spinal Cord Injury

Start date: August 2016
Phase:
Study type: Observational

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.

NCT ID: NCT02819817 Withdrawn - Injuries and Wounds Clinical Trials

A Trial of Topical Aloe Vera Gel in Emergency Department Patients Presenting With Simple Traumatic Wounds

ALOE
Start date: April 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.

NCT ID: NCT02776800 Withdrawn - Wounds and Injuries Clinical Trials

Managing Wounds With Allevyn Life in a Home Health Care Environment

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

When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Working with the patient's physician, the home health provider will use the appropriate wound covering ("dressing" or "bandage") to cover the wound. The goal of the home health provider is to ensure that the wound stays clean and progresses toward closure. The home health provider will conduct in-home patient visits at appropriate intervals to assess the status of the wound. Extensive resources are required to see patients in their own homes. If a dressing could effectively manage wounds and allow longer time between in-home visits (without affecting patient safety or progress of the wound toward closure), then resources could be saved. Thus, newer dressings are designed for longer wear times, using advanced foam pads and adhesives that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn Life will decrease the number of in-home visits by home health providers without sacrificing patient safety.

NCT ID: NCT02776488 Withdrawn - Clinical trials for Brain Injuries, Traumatic

Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)

ELI-TBI
Start date: September 2020
Phase: Phase 2
Study type: Interventional

Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof of concept that exogenous fuels alter brain metabolism. We will conduct a multicenter, adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels in patients with severe traumatic brain injury to determine safety and efficacy.

NCT ID: NCT02732548 Withdrawn - Complex Wound Clinical Trials

MIRODERMâ„¢ for Complex Wounds in an Inpatient Setting (MIRODERM CLOSure)

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

This study is being conducted to collect data on the performance of Miromatrix Wound Matrix (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.

NCT ID: NCT02698228 Withdrawn - Fracture Clinical Trials

Regional Anaesthesia for Painful Injuries After Disasters

RAPID
Start date: March 2016
Phase: Phase 4
Study type: Interventional

The goal of the RAPID study is to fundamentally transform the way serious injuries are managed after earthquakes and other disasters by introducing a novel and cost-effective method for pain control. The study will enroll patients in the aftermath of a major earthquake to determine whether regional anesthesia, either with or without ultrasound-guidance, can reduce suffering from lower limb injuries, the most common earthquake-related injury, above and beyond the current standard of care for pain control in these settings.

NCT ID: NCT02599844 Withdrawn - Hypertension Clinical Trials

Impact of Pediatric Acute Renal Injury in Severe Sepsis in Young Adults

IMPRESS-YA
Start date: December 2015
Phase:
Study type: Observational

Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.