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Burns clinical trials

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NCT ID: NCT01443689 Recruiting - Burns Clinical Trials

Allogenic Stem Cell Therapy in Patients With Acute Burn

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years,stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.

NCT ID: NCT01439074 Completed - Burn Injuries Clinical Trials

Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.

NCT ID: NCT01437852 Completed - Burns Clinical Trials

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

Start date: September 2011
Phase: Phase 1
Study type: Interventional

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.

NCT ID: NCT01436292 Withdrawn - Clinical trials for Second or Third Degree Burns

Hypoalbuminemia in Burn Patients

Halburns
Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether 5% human albumin solution, given to correct hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).

NCT ID: NCT01433198 Withdrawn - Burns Clinical Trials

Aquatic Training in Patients With Severe Scarring

Start date: May 2018
Phase: N/A
Study type: Interventional

Aim: - to investigate the effects of an aquatic exercise program in patients with severe scars Patient population: - 10 patients of at least 18 years old - patients with scars after burns or other severe skin injuries - stratification into two groups: an intervention group and a control group Method: - 8 patients will participate in the aquatic exercise group and 2 patients in the control group - assessment of physical fitness parameters, scar tissue and psychosocial impact Hypothesis: - patients of the aquatic exercise group will recover sooner and better (physically and psychologically) than patients of the control group

NCT ID: NCT01421537 Completed - Skin Burn Extensive Clinical Trials

Evaluation Of Enoxaparin Pharmacokinetic For Thromboprophylaxis In Burn Care Patients

Start date: January 2011
Phase:
Study type: Observational

OVERVIEW: - Thromboembolisms represent a serious and feared complication in hospitalized patients. - Several factors make the ICU patient population at increased risk of venous thromboembolism. - A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient. - Actual guidelines for thromboprophylaxis in burn care patients are based on multiple non-burn patient trials. - Burn patient physiology is radically different than that of general ward hospitalized patients - Since the actual chemical thromboprophylaxis have not been evaluated in the burn patient, it is of interest to assess their efficacy in patients with severe burns. - Hence, the pharmacokinetic characterization of heparins (a well accepted mode of thromboprophylaxis) in burn patients could guide future quality of care for this subclass of patients. Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight heparins in the burn patients do not correlate with levels described to prevent thromboembolic events in the general hospitalized population. The investigators aim to: 1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins (enoxaparin), with anti-Xa levels in severely burned patients receiving thromboprophylaxis. 2. To determine the correlation between antithrombotic activity of heparins and the different metabolic phases of the thermally injured patient.

NCT ID: NCT01418482 Completed - Burns Clinical Trials

Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well

NCT ID: NCT01413620 Withdrawn - Burn Injury Clinical Trials

Vitamin E Supplementation in Burn Patients

Start date: August 2011
Phase: Phase 1
Study type: Interventional

Burned patients because of their increased oxidative stress have severely depleted vitamin E, which is a dietary antioxidant. Oxidative stress is responsible for much of the pathophysiology seen in burned patients, which leads to acute and chronic morbidity and mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining adequate vitamin E status.

NCT ID: NCT01404026 Completed - Pain Clinical Trials

Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury

Start date: June 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The investigators hypothesize that the active tDCS group will show a significant pain/itch reduction when compared to sham stimulation.

NCT ID: NCT01383187 Completed - Burns Clinical Trials

Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma

Start date: November 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of the affected area has become the golden standard for the treatment of deep partial thickness and full thickness skin burns and represents the treatment of choice. Despite of all the progress achieved in the treatment process (artificial skin, cultured keratinocytes), the therapeutic results are sometimes unacceptable due to functional and cosmetic deficits causing severe psychological and emotional distress, particularly in the form of disfiguring and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement, peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation disorders. Consequently, the quality of life is markedly decreased. That is why new methods of burn wounds covering are intensively searched. Based upon the results of available pre-clinical studies, the local use of autologous platelet concentrate with their active growth factors appears to be a good and promising possibility how to improve faster and higher quality of healing deep skin burn wounds.