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Burns clinical trials

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NCT ID: NCT00352729 Withdrawn - Burns Clinical Trials

Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

ACell
Start date: November 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds. Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

NCT ID: NCT00351741 Terminated - Burns Clinical Trials

BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-

Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation. Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.

NCT ID: NCT00350077 Withdrawn - Burns Clinical Trials

The Effect of High Dose Vitamin C in Burn Patients

Vitamin C
Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours.

NCT ID: NCT00343824 Completed - Clinical trials for Burn Wounds - Partial Thickness (2nd Degree)

Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

Start date: November 1, 2006
Phase: N/A
Study type: Interventional

This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.

NCT ID: NCT00329654 Completed - Burns Clinical Trials

James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth

Start date: March 2006
Phase: N/A
Study type: Interventional

This will be a prospective, randomized, single blinded, controlled study in a single center setting to assess the effect of either phototherapy with the Embar® light therapy or sham irradiation.

NCT ID: NCT00326859 Terminated - Pain Clinical Trials

Comparison of Monitored Anesthesia Care Using Remifentanil or Fentanyl for Major Dressing Changes in Burns

Start date: August 2005
Phase: Phase 4
Study type: Interventional

During their hospitalization, burn patients frequently require dressing changes that may be painful. Deep analgesia and sedation are used but carry the risk of remnant somnolence and other effects of anesthesia such as dizziness and nausea/vomiting. All these side effects may delay refeeding after the procedure, ambulation and physical therapy. Drugs from the opioid class are used to relieve pain during these procedures. Morphine with its slow onset and remnant sedation is difficult to use in these patients. Pro-emetic properties and histamine liberating effects also make this drug non optimal for iterative procedures. Fentanyl, a synthetic opioid with shorter onset and lower incidence of nausea and vomiting, is the standard drug used in dressing changes in burn patients. It is metabolized by hepatic glucoconjugation. Remifentanil, a well known novel opioid, that has a unique metabolism independent from renal or hepatic functions, is metabolized by a non specific esterase. It has a very short half-life (3.5 minutes) and should therefore be administered as a continuous infusion. The investigators hypothesized that the use of remifentanil for daily burn dressing changes is associated with less pain during procedures and faster recovery. Studied patients will be the ones requiring iterative dressing change procedures under sedation. The primary endpoint will be the maximal pain during the procedure. Secondary endpoints will be: average pain during and after the procedure; subjective sensation of comfort; total amount of opioids received; times to feeding after the procedure and ambulation after the procedure; comfort of the procedure according to the nurses; mobilisation according to the physical therapist; and safety of the analgesia technique. The study will be conducted according to the recommendations of the American Society of Anesthesiologists (ASA) that have been endorsed by the Canadian Anaesthetists' Society (CAS). All patients who consent will fast for at least 6 hours before the procedure. The two following regimens will be compared: a bolus infusion of fentanyl, starting with 1 µg/kg, followed by 0.5 µg/kg as needed every 5 to 10 minutes versus continuous infusion of remifentanil adapted to ensure analgesia. The initial dose of remifentanil will be 0.1 µg/kg/min to be adjusted between 0.05 µg/kg/min and 2 µg/kg/min. To allow blinding during the study, patients will receive a double-blinded protocol with sham (normal saline) in one arm. In other words: for each procedure, the patient will always receive boluses, either of fentanyl or saline, and a perfusion, either of remifentanil or saline. According to power calculations, 30 patients will be necessary to achieve the primary end-points. The investigators plan to enroll 40 patients in the study to allow for some drop outs and to increase their statistical power.

NCT ID: NCT00326729 Recruiting - Burns Clinical Trials

Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation

Start date: May 2006
Phase: Phase 4
Study type: Observational

Fluid resuscitation in burn patients is associated with major macrocirculatory and microcirculatory disturbances that have been poorly described. When done according to expert opinions, it is now rare to encounter the death of a patient due to an inadequate fluid resuscitation. Fluid resuscitation in burn patients is more opinion-based than evidence-based. Although burn admission to an intensive care facility is relatively rare, the burn patient is well suited to answer questions in the fluid resuscitation field because, as opposed to other critically ill patients: 1. investigators do have a time ‘zero’ for burn patients; they know exactly when the insult occurred; 2. apart from fluid resuscitation, the management of burn patients is uniform in the investigators' unit and is done according to various protocols; 3. the burn population is more uniform than the septic population making confounders and background noises less likely; and 4. as basic as it might sound, studying fluid resuscitation implies accomplishing a significant one; burn patients are the category of critically ill patients receiving the most important fluid resuscitation. Studies that have addressed the question of fluid resuscitation in burn patients are quite numerous. However, they are either under-powered, dealing with various interventions or outcomes and sometimes of poor methodological quality. Moving the investigators' focus from macrohemodynamic to microhemodynamic monitoring is now essential and due to recent technological advances, severe impairments in microcirculatory perfusion are now being recognized in various pathological states. What is now clear from various studies is the fact that even with restoring ‘normal’ macrocirculatory parameters, severe microcirculatory alterations can be seen. This study is an integral part of a program aimed to explore different questions regarding fluid resuscitation in burn patients. The aim is to characterize changes in fluid shift, fluid accumulation, and vascular volumes after burn injury and also to study the effects of an artificial colloid on different macrocirculatory and microcirculatory parameters. The primary end points are: 1. fluid accumulation during the initial phase; and 2. short term effects of colloids on macrocirculatory and microcirculatory parameters. This study will collect data on macro- and microcirculation derived from current monitoring systems. Data (see below) will be collected at defined time points and before and after the first two fluid challenges. If the fluid challenge occurs in a one hour time frame of a defined time point, only one assessment will be done. 1. At defined time points: a set of data (see below) will be collected by the research team at baseline, 6, 12, 18, 24, 36, 48 and 72 hours after burn injury. Baseline values will be the ones obtained immediately after consent. 2. Fluid challenges: Burn patients often require additional fluid bolus to maintain hemodynamic stability because of the following reasons: hypotension; decreased urine output (less than 0.5 ml/kg/hour); uncorrected metabolic acidosis; rhabdomyolysis; increasing hematocrit; or any other clinical reason according to the attending physician. In this study, the two first fluid challenges will be allocated according to a random list. One bolus will be Pentaspan (500 ml) and the other will be a crystalloid solution (Ringer's lactate 1000 ml). These two alternatives represent a true equipoise as they are equally acceptable because choosing one of them depends on the preference of the attending physician. Fluid challenges will be allocated using a randomised short block cross-over sequence. The following parameters will be measured at a fixed time and before and after the fluid challenges using different techniques. Parameters: Intrathoracic blood volume, extravascular lung water, total blood volume; extracellular edema; intraventricular preload, ventricular volumes, diastolic function; cardiac output; mixed venous saturation; oncotic pressure; microcirculatory assessment: number and diameter of capillaries, proportion of perfusion, and flow velocities. This is an observational, one-group study aimed at describing macrocirculation and microcirculation parameters in a burn patient population. The investigators arbitrarily plan to enroll 40 patients.

NCT ID: NCT00324311 Completed - Burn Clinical Trials

Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care

Start date: December 2005
Phase: Phase 3
Study type: Interventional

Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of local and/or systemic infection or sepsis. The local inflammation and infection destroy healthy surrounding tissues and extends the original damage. In order to prevent these complications, and in order to minimize the risk of infection, it is imperative to evaluate the burn and remove all of the offending eschar at the earliest possible opportunity. This removal of dead tissue is termed "debridement". The most direct debridement method for eschar removal is surgery. Traditional, conservative non-surgical debridement is a lengthy process which often involves many complications. The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full thickness thermal burns and to compare DGD to standard of care (SOC).

NCT ID: NCT00297752 Completed - Burns Clinical Trials

Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing

Start date: March 2006
Phase: Phase 4
Study type: Interventional

The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing. In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome. Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support. By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.

NCT ID: NCT00294983 Withdrawn - Burns Clinical Trials

OCD Among Patients With Burns

Start date: n/a
Phase: N/A
Study type: Observational

Estimating the prevalence of OCD symptoms among patients with burns