Clinical Trials for Burns

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Burns is grouped into the following categories:-

• View by trial name
• View by drugs used in Burns clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Burns:

• Phase II Randomized Study of Cultured Skin Substitutes Versus Split Thickness Skin Grafts in Patients With Severe Burn Injuries - This study is currently recruiting patients (Current: 23 Nov 2006)
• Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury - This study is currently recruiting patients (Current: 23 Nov 2006) - testosterone
• Evaluation of Dermafill Dressing for Donor Sites - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites - This study is currently recruiting patients (Current: 23 Nov 2006)
• The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns - This study is currently recruiting patients (Current: 23 Nov 2006) - cerium nitrate-silver sulfadiazine (cerium-flamazine)
• Efficacy of a Fibrin Sealant in Burn Surgery - This study is currently recruiting patients (Current: 23 Nov 2006) - Tisseel Fibrin Sealant
• Effect of rFVIIa on Peri-Operative Blood Loss in Patients Undergoing Major Burn - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Recombinant Factor VIIa
• Psychometric Study of Outcomes Instruments - This study is currently recruiting patients (Current: 23 Nov 2006)
• Fluid Shifts During Resuscitation: Impacts on Macrocirculation and Microcirculation - This study is currently recruiting patients (Current: 23 Nov 2006)
• The Effect of High Dose Vitamin C in Burn Patients - This study is currently recruiting patients (Current: 23 Nov 2006) - Intravenous Vitamin C
• BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study- - This study is currently recruiting patients (Current: 23 Nov 2006)
• Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Anorexia in Children With Burn Injury and the Reactions of the Immune and Endocrine Systems - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Insulin on Post Burn Hypermetabolism - This study is currently recruiting patients (Current: 23 Nov 2006) - Insulin,Stable Isotopes,Indocyanine Green
• Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - ceriumnitrate silversulfadiazine (flammacerium),silversulfadiazine (flammazine)
• Evaluation of Hand Assessments in Children With Severe Hand Burns - This study is currently recruiting patients (Current: 23 Nov 2006)
• Low-Dose Hydrocortisone in Acutely Burned Patients - This study is currently recruiting patients (Current: 23 Nov 2006) - hydrocortisone 200 mg/day
• Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors - This study is currently recruiting patients (Current: 23 Nov 2006)
• Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans - This study is currently recruiting patients (Current: 23 Nov 2006)
• Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury - This study is currently recruiting patients (Current: 23 Nov 2006) - Calcium and Vitamin D Supplementation
• Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition - This study is currently recruiting patients (Current: 23 Nov 2006) - The "drug" is actually standard vs. glutamine enriched enteral or parenteral feeding formulas
• Study of Arginine Metabolism and Nitric Oxide Formation in Relation to Glutamine Supply in Severely Burned Patients. - This study is currently recruiting patients (Current: 23 Nov 2006) - Drug: The "drug" is actually arginine-, proline-, and glutamate-depleted TPN vs. glutamine enriched TPN feeding formulas
• Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding - This study is currently recruiting patients (Current: 23 Nov 2006) - The "drug" is actually standard TPN vs. proline depleted TPN feeding formulas and their effects on whole body proline balance and metabolism
• Study on the Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Severely Burned Patients. - This study is currently recruiting patients (Current: 23 Nov 2006) - The "drug" is glutamine enriched TPN vs. standard TPN and how it affects whole body nitrogen metabolism and whole body glutamine metabolism
• Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients - This study is currently recruiting patients (Current: 23 Nov 2006) - The "drug" is actually standard TPN vs. glutamine enriched TPN feeding formulas and their effects on proline metabolism
• Phase 2 Trial of TD 6424 Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections - This study has been completed (Current: 23 Nov 2006) - TD-6424
• Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Research to Improve Smoke Alarm Functioning and Maintenance - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds - This study has been completed (Current: 23 Nov 2006) - Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
• Lactobacillus GG Supplementation During Pediatric Burn Injuries - This study is currently recruiting patients (Current: 23 Nov 2006) - Lactobacillus GG
• Evaluation Of Linezolid Pk Profil In Burns Patients - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - linezolid
• Inflammation and the Host Response to Injury (Trauma) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Inflammation and the Host Response to Injury (Burns) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns - This study is currently recruiting patients (Current: 23 Nov 2006) - Soluble beta-1,3/1,6-glucan
• OCD Among Patients With Burns - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Comparison of Monitored Anesthesia Care Using Remifentanil or Fentanyl for Major Dressing Changes in Burns - This study is currently recruiting patients (Current: 23 Nov 2006) - remifentanil
• Substrate Cycling in Energy Metabolism - This study is no longer recruiting patients (Current: 23 Nov 2006) - fenofibrate
• Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries - This study is currently recruiting patients (Current: 23 Nov 2006) - Dermal substrate cellularised LG002 (10x10cm)
• Beta Blocker for Chronic Wound Healing - This study is currently recruiting patients (Current: 23 Nov 2006) - Timoptic
• Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain - This study is currently recruiting patients (Current: 23 Nov 2006) - ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])
• Hypertrophic Scarring After Facial Burn - This study is currently recruiting patients (Current: 23 Nov 2006)
• VRH Pain Reduction During Burn Wound Care and Physical Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Virtual Reality Pain Control During Burn Wound Care - This study is currently recruiting patients (Current: 23 Nov 2006)
• Long Term Follow-Up of Burn Injuries - This study is currently recruiting patients (Current: 23 Nov 2006)
• Genetic Variation and Immune Responses After Injury - This study is currently recruiting patients (Current: 23 Nov 2006)
• Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care - This study is currently recruiting patients (Current: 23 Nov 2006) - Debrase Gel Dressing
• Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples - This study has been completed (Current: 23 Nov 2006)
• the Role of Amniotic Membrane Transplantation in Ocular Chemical Burns - This study is currently recruiting patients (Current: 23 Nov 2006)
• JAMES EMBAR LIGHT THERAPY in the Treatment of Burn Wounds of Intermediate Depth - This study is currently recruiting patients (Current: 23 Nov 2006)
• Bacterial Control in Partial Thickness Burns Using Silver-Containing Wound Dressings - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids. - This study is currently recruiting patients (Current: 23 Nov 2006) - corticosteroids
• Clinical Safety Trial of Long-Term Intermittent Use of Helioblock SX Cream - This study is currently recruiting patients (Current: 23 Nov 2006) - Helioblock® SX Cream
• Impedance Threshold Device Tilt Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• Phase 2 Trial of TD-6424 Versus Standard Therapy for Complicated Gram Positive Infections of the Skin and Soft Tissue - This study has been completed (Current: 23 Nov 2006) - TD-6424
• A Study of Sertraline to Prevent PTSD - This study is currently recruiting patients (Current: 23 Nov 2006) - Sertraline(drug)
• Efficacy/Safety Study of ACTIQ for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP) - This study is currently recruiting patients (Current: 23 Nov 2006) - ACTIQ®
• Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients - This study is currently recruiting patients (Current: 23 Nov 2006) - Fibrin Sealant, Tisseel 4IU/ml VH SD
• Topical Morphine for Analgesia in Patients With Skin Grafts - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - morphine
• Post Burn Pruritus Study: Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing - This study is currently recruiting patients (Current: 23 Nov 2006) - Ondansetron (Zofran),Diphenhydramine (Benadryl)
• Hand Edema in Burn Patients - This study is no longer recruiting patients (Current: 23 Nov 2006)

Drugs used in Clinical Trials for Burns

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Burns:

• ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain - This study is currently recruiting patients (Current: 23 Nov 2006)
• ACTIQ® - Efficacy/Safety Study of ACTIQ for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Calcium and Vitamin D Supplementation - Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury - This study is currently recruiting patients (Current: 23 Nov 2006)
• Cerium Nitrate-Silver Sulfadiazine (Cerium-Flamazine) - The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns - This study is currently recruiting patients (Current: 23 Nov 2006)
• Ceriumnitrate Silversulfadiazine (Flammacerium) - Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Corticosteroids - The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids. - This study is currently recruiting patients (Current: 23 Nov 2006)
• Debrase Gel Dressing - Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care - This study is currently recruiting patients (Current: 23 Nov 2006)
• Dermal substrate cellularised LG002 (10x10cm) - Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries - This study is currently recruiting patients (Current: 23 Nov 2006)
• Diphenhydramine (Benadryl) - Post Burn Pruritus Study: Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing - This study is currently recruiting patients (Current: 23 Nov 2006)
• Drug: The "drug" is actually arginine-, proline-, and glutamate-depleted TPN vs. glutamine enriched TPN feeding formulas. - Study of Arginine Metabolism and Nitric Oxide Formation in Relation to Glutamine Supply in Severely Burned Patients. - This study is currently recruiting patients (Current: 23 Nov 2006)
• Fenofibrate - Substrate Cycling in Energy Metabolism - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Fibrin Sealant, Tisseel 4IU/ml VH SD - Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Helioblock® SX Cream - Clinical Safety Trial of Long-Term Intermittent Use of Helioblock SX Cream - This study is currently recruiting patients (Current: 23 Nov 2006)
• Hydrocortisone 200 Mg/Day - Low-Dose Hydrocortisone in Acutely Burned Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Indocyanine Green - Insulin on Post Burn Hypermetabolism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Insulin - Insulin on Post Burn Hypermetabolism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Intravenous Vitamin C - The Effect of High Dose Vitamin C in Burn Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Lactobacillus GG - Lactobacillus GG Supplementation During Pediatric Burn Injuries - This study is currently recruiting patients (Current: 23 Nov 2006)
• Linezolid - Evaluation Of Linezolid Pk Profil In Burns Patients - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Morphine - Topical Morphine for Analgesia in Patients With Skin Grafts - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Ondansetron (Zofran) - Post Burn Pruritus Study: Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing - This study is currently recruiting patients (Current: 23 Nov 2006)
• Recombinant Factor VIIa - Effect of rFVIIa on Peri-Operative Blood Loss in Patients Undergoing Major Burn - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Remifentanil - Comparison of Monitored Anesthesia Care Using Remifentanil or Fentanyl for Major Dressing Changes in Burns - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sertraline(drug) - A Study of Sertraline to Prevent PTSD - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin - Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds - This study has been completed (Current: 23 Nov 2006)
• Silversulfadiazine (Flammazine) - Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Soluble beta-1,3/1,6-glucan - Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns - This study is currently recruiting patients (Current: 23 Nov 2006)
• Stable Isotopes - Insulin on Post Burn Hypermetabolism - This study is currently recruiting patients (Current: 23 Nov 2006)
• TD-6424 - Phase 2 Trial of TD 6424 Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections - This study has been completed (Current: 23 Nov 2006)
• TD-6424 - Phase 2 Trial of TD-6424 Versus Standard Therapy for Complicated Gram Positive Infections of the Skin and Soft Tissue - This study has been completed (Current: 23 Nov 2006)
• Testosterone - Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury - This study is currently recruiting patients (Current: 23 Nov 2006)
• The "drug" is actually standard TPN vs. glutamine enriched TPN feeding formulas and their effects on proline metabolism - Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• The "drug" is actually standard TPN vs. proline depleted TPN feeding formulas and their effects on whole body proline balance and metabolism - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding - This study is currently recruiting patients (Current: 23 Nov 2006)
• The "drug" is actually standard vs. glutamine enriched enteral or parenteral feeding formulas. - Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition - This study is currently recruiting patients (Current: 23 Nov 2006)
• The "drug" is glutamine enriched TPN vs. standard TPN and how it affects whole body nitrogen metabolism and whole body glutamine metabolism. - Study on the Effect of Glutamine Supplemented Nutrition Support on Protein and Glutamine Metabolism in Severely Burned Patients. - This study is currently recruiting patients (Current: 23 Nov 2006)
• Timoptic - Beta Blocker for Chronic Wound Healing - This study is currently recruiting patients (Current: 23 Nov 2006)
• Tisseel Fibrin Sealant - Efficacy of a Fibrin Sealant in Burn Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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