View clinical trials related to Burns.
Filter by:This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
In patients with moderate to severe thermal injuries (> 20% TBSA) adequate fluid resuscitation is the main priority to achieve successful outcomes. Soon after burn injury substantial amounts of fluid accumulate rapidly in the wound while more is lost in the third space. Without intervention this process leads to hypotension and shock. The Parkland formula was devised to calculate how much intravenous (IV) fluid, i.e. crystalloids, is needed for adequate resuscitation during the first 24 hours post-burn. However, IV resuscitation can lead to overexpansion of (third space) volume, leading to severe complications such as compartment syndrome or pulmonary edema. In major population centers, catastrophic events causing mass casualties will disrupt many hospital and emergency services, potentially delaying acute IV fluid resuscitation. Burn patient case reports have shown that oral rehydration therapy (ORT) used to supplement or in place of IV therapy is efficacious. ORT could be easily applied in mass burn casualties. ORT is generally known in the third world for treating life-threatening dehydration due to diarrhea. The glucose-sodium co transport mechanism enables the affected human intestine to absorb a sufficient amount of water and electrolytes to replace large fluid losses due to severe diarrhea, even under adverse field conditions. No electrolyte disturbances have been recorded in such cases. Studies on enteral resuscitation in animal burn models showed high rates of small intestinal absorption which should be adequate for resuscitation following major burn injury. The optimal composition of oral rehydration solution for resuscitation in burn wounds has not been determined. In cholera patients, Ceralyte® has proven superior to the World Health Organization Oral Rehydration Solution, increasing fluid absorption of the intestine. The Ceralyte® 90 solution, with 90mEq/L sodium and a low osmolarity of <275mOsm, may also contribute to optimal intestinal fluid uptake without causing electrolyte disturbances in thermal injury. ORT use might reduce the occurrence of compartment syndrome and pulmonary edema since fluid is regulated by the intestine according to physiologic requirements. The investigators propose to conduct a prospective study using Ceralyte® 90 to show that oral resuscitation therapy (ORT) in burns can reduce the total amount of IV fluid needed for adequate resuscitation and to test the efficacy and safety of ORT in the resuscitation of burn patients.
The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.
The evidence is insufficient to determine whether the types of dressings containing silver differ in time / proportion for complete wound healing and pain. We will analyze the cost-effectiveness of these dressings in outpatients, considering the service provided by the Brazilian National Public Health System.
This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels. Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs. Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.
Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery. The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.
Background: Previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children. Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries. Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention consists of two face-to-face sessions (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.
The purpose of this study is to determine the effect of β-glucans on wound healing.
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks