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NCT ID: NCT02394873 Completed - Burn Clinical Trials

A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.

NCT ID: NCT01983280 Completed - Burn Clinical Trials

The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients

Sleep5
Start date: October 2009
Phase: N/A
Study type: Interventional

Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

NCT ID: NCT01965340 Completed - Burn Clinical Trials

Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission

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

Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs several weeks, or even months after injury as a consequence of sepsis usually caused by multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR bacteria. Correct prescription of anti-infective agents could be one way to curb the steadily increasing development of multidrug resistance. Administration of antibiotic to burn patient is complex: they frequently suffer from kidney dysfunction, they usually experience tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular compartments, they often are hypo-albumin and protein-emic, and finally they present with a profoundly modified metabolism. All those aspects make this particular population of patients at high risk of both under or over prescription. Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic Drug Monitoring, has been introduced to clinical practice for several decades primarily to avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the increasing availability of detection techniques, the number of drugs that can be measured in the plasma of patients has grown tremendously over the last decade. As a consequence, it is currently possible to monitor drug concentrations not only to prevent toxicity, but also to improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic prescription in different populations of hospitalized patients, including critically ill patients, with a direct impact on outcome. Such studies amongst burn patients are however lacking, although this particular population is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM could improve antibiotic prescription in this peculiar population. To this end, we propose to implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze the impact of systematic TDM on anti-infective agent prescription amongst burned patients.

NCT ID: NCT01939613 Completed - Burn Clinical Trials

Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

Start date: July 2010
Phase: N/A
Study type: Observational [Patient Registry]

The present study was to evaluate the effectiveness of colloid compared with crystalloids for fluid resuscitation in critical burn patients with total burn surface area ≥50%.

NCT ID: NCT01926392 Completed - Burn Clinical Trials

Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns

Start date: April 2011
Phase: Phase 4
Study type: Interventional

Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.

NCT ID: NCT01889537 Completed - Burn Clinical Trials

Low Dose Ketamine VR Analgesia During Burn Care Procedure

VRK
Start date: July 2012
Phase: Phase 2
Study type: Interventional

The purpose of the research is to see whether a low dose of ketamine, a medication used to reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a form of distraction from pain during a painful burn care procedure.

NCT ID: NCT01749371 Completed - Burn Clinical Trials

Vitamin E Supplementation in Burned Patients

Start date: February 2013
Phase: Phase 2/Phase 3
Study type: Interventional

A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.

NCT ID: NCT00993889 Completed - Burn Clinical Trials

Virtual Reality Analgesia During Pediatric Physical Therapy

VRD/Peds
Start date: May 2009
Phase: N/A
Study type: Interventional

We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

NCT ID: NCT00898521 Completed - Burn Clinical Trials

Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns

Start date: December 20, 2009
Phase: Phase 2
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 objectives of this study are as follows: 1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been taken in previous studies involving deeper wounds to control safety parameters (such as pain, fever and infection). Nevertheless, as part of the effort to expand the burn population in the future phase 3 study to the more superficial wound group, it is important to first explore these parameters in a small group involving this burn population. 2. To explore DGD absorption as measured by Pharmacokinetic testing.

NCT ID: NCT00879723 Completed - Burn Clinical Trials

Burn Micronutrient Repletion Pilot Study

Start date: August 2010
Phase: Phase 1
Study type: Interventional

Burn injury patients undergo a series of metabolic changes that, if untreated, could lead to reduced health outcomes. Nutrition is thought to play a vital role in post-burn recovery. The research team developed a novel vitamin and mineral supplementation protocol based on current scientific literature. The study will test the hypothesis that the novel vitamin and mineral supplement regimen will improve adult patient recovery from burn injury.