Treatment Trials

5 Clinical Trials for Various Conditions

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COMPLETED
NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Description

The purpose of this study is to measure peak skin interface pressures and the total area of the body exposed to skin interface pressure above 30 mm Hg at different areas of the body in the supine position on two different support surfaces applied to a standard North Atlantic Treaty Organization (NATO) litter (NSN: 6530-01-380-7309) and a Raven 90C Litter (NSN6530-01-432-5114). The support surfaces are the Warrior Evacuation Litter Pad (WELP) and the Dolphin Fluid Immersion Simulation Stretcher System (FIS). These pressure measurements and transcutaneous oxygenation readings will allow us to determine differences between support surfaces.

RECRUITING
A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 5% Total Body Surface Area Burns
Description

This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 5% TBSA. Enrolled subjects must have at least 1% TBSA deep partial-thickness burns. Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times. Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing. Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.

Conditions
COMPLETED
A Randomized Trial Evaluating EARLY Application of a Surfactant Dressing in Thermal Injury (EARLY)
Description

The purpose of this study is to test the following hypotheses: 1. Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden. 2. Early use of WSD on partial-thickness burn wounds will result in faster healing. 3. Use of WSD on partial-thickness burn wounds will result in less painful wound care. 4. Early use of WSD on partial-thickness burn wounds will result in less infection. 5. Early use of WSD on partial-thickness burn wounds will result in lower hospital costs.

WITHDRAWN
Cardiac Output Monitoring in Burn Patients
Description

The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.

Conditions
UNKNOWN
The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury
Description

The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

Conditions