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Wounds and Injuries clinical trials

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NCT ID: NCT01848821 Completed - Wound Healing Clinical Trials

The Effect of OASIS Ultra on Critical Sized Wound Healing

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovascularization present compared with control wounds. The investigators hypothesize that OASIS® Ultra will provide a faster healing time as well as the re-establishment of a dermis for further skin graft application. The investigators anticipate that our study will define parameters for the application of OASIS® Ultra as well as potentially demonstrating the advantages in healing time, healed wound quality and hospital stay.

NCT ID: NCT01847755 Completed - Clinical trials for Traumatic Brain Injury

Hyperbaric Treatment of Traumatic Brain Injury (TBI)

TBI
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to test the hypothesis that patients with Traumatic Brain Injury (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement is evidenced by increase in number of pixels on SPECT Scan and increased brain metabolism. Improvement may also be identified via cognitive assessments administered by Jupiter Medical Center Research Department.

NCT ID: NCT01847040 Completed - Clinical trials for Mild Traumatic Brain Injury

Deployment Related Mild Traumatic Brain Injury (mTBI)

Start date: September 2009
Phase:
Study type: Observational

The study will provide evidence on the long term outcomes of mTBI in service members returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be combined with data on health care utilization and military job performance. The work, symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI, combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at one year. The assessments over time will permit descriptions of symptom changes for these populations. It is likely the study will find similar findings to those of previous civilian studies - that concussive symptoms often resolve within months of injury. However, some soldier subsets may have chronic problems. Determining the incidence and outcomes of individuals with mTBI will assist medical providers in determining the types of follow-ups needed by returning service members and suggest the development of additional treatment interventions. These results may also inform treatment of civilian populations with mTBI. The three primary hypotheses are: 1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and symptoms persisting 3 months, 6 months, and 12 months after return will be associated with extent of exposure to combat, injury mechanism, associated injuries (co-occuring injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related mTBIs. 2. Returning troops reporting concussive symptoms at the time of return from deployment will have more work related problems at each follow-up (including lower rates of return to duty, return to work, and poor quality of work). 3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the criterion measure, which is a structured interview conducted by clinicians blinded to the screening results.

NCT ID: NCT01846546 Completed - Clinical trials for Traumatic Brain Injury

Cerebrospinal Fluid Endostatin/Collagen XVIII Concentrations in Patients With Severe Traumatic Brain Injury

Start date: October 2006
Phase:
Study type: Observational [Patient Registry]

Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. The aim of this study was to investigate early changes in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen XVIII concentrations were measured serially for 1 week after hospitalization by using the enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to determine if its serial changes correlate with the GCS score and prognosis. Receiver operating characteristic curve was used to appraise the value of CSF endostatin/collagen XVIII levels in predicting the prognosis of patients with severe head injury.

NCT ID: NCT01845415 Completed - Wounds and Injuries Clinical Trials

Intervention to Prevent Fall Injuries to Young Children in the Home

Start date: October 2013
Phase: N/A
Study type: Interventional

Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the developed and implementation of a social marketing intervention campaign aimed at lowering the incidence of falls to children in the home; City of Hamilton - Public Health Services (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health, Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign is based on community-based intervention research and 'best practices' for improving parent attitudes and behaviours toward child safety. The campaign will focus on increasing parents' awareness and knowledge of fall injuries, positively impact parental attitudes to motivate them to want to implement strategies to reduce fall risks, and increase parental safety practices that would counteract the most common mechanisms that contribute to home falls for children at these young ages. The campaign will run from September 2013 through August 2014. The PHUs' social marketing campaign will strategically disseminate different materials to their respective communities: printed materials (posters, pamphlets), video modules about parenting safety, safety information through an e-Health website, and direction communication with parents through Family Health Team practitioners. The proposed research project will request archival data from Canadian Institute of Health Information (CIHI), specifically from their National Ambulatory Care Reporting System (NACRS), on frequency of falls in the home to determine the extent to which the social marketing campaign is effective. Comparing pre-, during and post-intervention levels in the PHU communities will determine if and which social marketing strategies were effective. Additionally, random digit dialing will be used to assess pre vs post parental fall related attitudes, behaviors and intervention exposure. This evaluation will provide the first ever test of a community level intervention to reduce childhood falls in the home in Canada and will provide valuable information about what constitutes 'best practices' for preventing falls in the home among children 1 through 4 years of age.

NCT ID: NCT01840241 Completed - Acute Kidney Injury Clinical Trials

Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)

Start date: April 1, 2013
Phase: N/A
Study type: Interventional

In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.

NCT ID: NCT01836237 Completed - Clinical trials for Pancreatic Neoplasms

The Use of Wound Protector in Whipple's Procedure With Intrabiliary Stent

Start date: February 2013
Phase: N/A
Study type: Interventional

Background: There are no published studies regarding the use of wound protectors in the context of surgical site infection (SSI) rates among patients receiving a pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative biliary stent placement for bile duct decompression represents the norm given typical surgical wait times. In addition to having higher associated lengths of hospital stay, ICU admissions, hospital re-admissions, and overall mortality, patients with SSI are also delayed, and often omitted, in their progression to critical oncologic adjuvant chemotherapy. As a result, SSI remain crucial and devastating complications for pancreas surgeons and their patients alike. Methods: The investigators will complete a randomized controlled trial evaluating the rate of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement when wound protectors are employed versus no wound protector use. This trial will employ block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB) surgeons will participate with a planned inclusion of all patients scheduled to undergo a pancreatoduodenectomy. Analysis: The investigators will use an intention to treat approach to the analysis. Categorical baseline data will be analyzed using the Fisher exact probability test. Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be determined using the Fisher exact probability test. Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a pancreatoduodenectomy with preoperatively placed intrabiliary stents. Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI following pancreatoduodenectomy, the epidemic incidence of this complication must be reduced. The additional crippling effect of refusing (Medicare) payment for any patient who receives a SSI in the United States has launched all techniques and analyses that can potentially reduce this complication into the National health care agenda. In Canada, health care utilization and economics are always a relevant and ever expanding area of importance. It is crucial that the investigators reduce complications such as SSI, regardless of individual payer sources.

NCT ID: NCT01835990 Completed - Trauma Clinical Trials

Feasibility Study of Geko vs. IPCs in Trauma

GIFT Pilot
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Trauma patients are at a high risk of developing blood clots in the legs (deep vein thrombosis - DVT), which can travel to the lungs and cause serious health consequences. Often, these patients cannot receive blood-thinning medication to prevent these blood clots because of the risk of bleeding; in this case, they are usually given intermittent pneumatic compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus reduce the risk of blood clot formation. Several studies suggest that IPCs are working properly on the patient only 60-70% of the time. Some patients also find them uncomfortable. A new device (geko) that works by stimulating the leg muscles and increasing blood flow in the legs has recently been developed. To compare the geko with IPCs, this study will randomly assign trauma patients who cannot receive blood thinners for blood clot prevention to either IPCs or geko. The main goal is to determine the feasibility of doing a larger study which would compare the efficacy of these devices in preventing blood clots. The amount of time the devices are properly used on the patients, comfort and tolerability, development of blood clots, and blood flow in the leg veins and arteries will also be measured and compared between the devices.

NCT ID: NCT01828749 Completed - Clinical trials for Blunt Abdominal Trauma

Pelvic CT Imaging in Blunt Abdominal Trauma

Start date: February 2013
Phase:
Study type: Observational

Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.

NCT ID: NCT01825044 Completed - Clinical trials for Traumatic Brain Injury

Copenhagen Head Injury Ciclosporin (CHIC) Study

CHIC
Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is an open label study on the pharmacokinetics and safety of ciclosporin in patients with severe traumatic brain injury, who require intensive care unit admission and monitoring of intracranial pressure via a ventricular catheter. 20 patients will be screened, and subsequently enrolled after clinical stabilisation. Thereafter, patients will receive 2.5 mg/kg bolus dose infusion of ciclosporin, followed by either 5 mg/kg/day or 10 mg/kg/day of ciclosporin as continuous infusion for 5 days+3 days monitoring at the intensive care unit. After an additional 30 days, a follow-up phone call will be made to the patient, or the patient's nursing staff, checking patient status and serious adverse events. The two dose levels will be investigated in 10 patients each, starting with the lower dose level for the first 10 patients. Patients will have samples of blood and cerebrospinal fluid drawn at pre-defined time points during the study for pharmacokinetic assessment and evaluation of biomarkers. Bedside monitoring with microdialysis and brain tissue oxygenation will be performed. The safety monitoring includes nephrotoxicity, hepatotoxicity, monitoring of intracranial pressure (ICP), infections monitoring and adverse events collection and reporting.