A Clinical Study of the Efficacy and Safety of MEBO® Wound Ointment in Subjects With Partial Thickness Burns
Summary
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with partial thickness burns.
Description
MEBO-BPII-001 is a single-center, randomized, standard care-controlled pilot study of topically applied MEBO in subjects with partial thickness burns expected to heal in 14 days. Twice daily application of MEBO versus standard of care will be evaluated in a parallel design. Fourteen subjects will be randomized (7 subjects per treatment arm) to one of two treatment groups. One study center located in the United States will participate in this trial.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Burns (Partial Thickness)
Intervention
MEBO Wound Ointment (MEBO), Standard practice for partial thickness burns
Status
Not yet recruiting
Source
Skingenix, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01297400
- Information obtained from ClinicalTrials.gov on April 04, 2013
Medical and Biotech [MESH] Definitions
Surgical Wound Dehiscence
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Negative-pressure Wound Therapy
The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.
Epilepsy, Partial, Sensory
A disorder characterized by recurrent focal onset seizures which have sensory (i.e., olfactory, visual, tactile, gustatory, or auditory) manifestations. Partial seizures that feature alterations of consciousness are referred to as complex partial seizures (EPILEPSY, COMPLEX PARTIAL).
Nuchal Translucency Measurement
A prenatal ultrasonic measurement of the thickness or translucent area below the SKIN in the back of the fetal NECK, or nape of the neck, during the first 11-14 weeks of gestation (PREGNANCY TRIMESTER, FIRST). Abnormal thickness or nuchal translucent measurements resulting from fluid collection, is associated with increased risks of CHROMOSOME ABNORMALITIES. (Nicolaides et al., 1992)
Epilepsies, Partial
Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317)
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