Ongoing Clinical Trials for Thermal Burns
There are currently 7 ongoing clinical trials studying new treatments and approaches for thermal burns. These studies are taking place across multiple countries in Europe and focus on various aspects of burn care, including infection prevention, skin grafts, blood loss reduction, and nutritional support during recovery.
Clinical trial locations
- Belgium
- France
- Study on Antibiotic Prophylaxis with Piperacillin, Tazobactam, and Cefazolin for Burn Patients Undergoing Excision-Graft Surgery
- Study on Glucose Use in Adults with Severe Burns
- Study on the Effectiveness of EHSG-KF Skin Graft for Patients with Deep Partial and Full-Thickness Burns
- Study on the Effects of High-Dose Vitamin C in Patients with Severe Burns
- Germany
- Italy
- Netherlands
- Study on the Effectiveness of EHSG-KF Skin Graft for Patients with Deep Partial and Full-Thickness Burns
- Study on the Safety and Effectiveness of EHSG-KF for Treating Deep Dermal and Full Thickness Burns in Children
- Study on EHSG-KF for Treating Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents
- Study on Tranexamic Acid and Sodium Chloride for Reducing Blood Loss in Patients Undergoing Burn Surgery
- Poland
- Portugal
- Spain
Study on Antibiotic Prophylaxis with Piperacillin, Tazobactam, and Cefazolin for Burn Patients Undergoing Excision-Graft Surgery
This trial is taking place in France and focuses on preventing infections after surgery in patients with burns. The surgery, called excision-autograft surgery, involves removing damaged skin and replacing it with healthy skin from another part of the patient’s body.
Who can participate: Adults over 18 years old with burns covering 5% to 40% of their body who need at least one skin graft surgery. Participants must sign a consent form or be included under emergency provisions if unable to sign.
Who cannot participate: Patients not undergoing this specific type of burn surgery, those outside the age range, those unable to give informed consent without emergency provisions, or those considered vulnerable populations.
What the trial studies: The study evaluates whether using antibiotics called Piperacillin Tazobactam and Cefazolin during surgery can prevent infections, sepsis, and complications where the new skin graft fails to heal properly. The antibiotics are given through an intravenous infusion directly into the bloodstream.
Main goal: To reduce the risk of infections within seven days after surgery and improve patient outcomes by monitoring recovery, healing, hospital stay length, and possible development of antibiotic-resistant bacteria.
Study on Glucose Use in Adults with Severe Burns
This French trial examines how the body processes glucose in the first four days after severe burn injury. The study uses an injectable glucose solution called GLUCOSE 30% PROAMP.
Who can participate: Adults over 18 years old with burns covering at least 30% of their body, caused by heat such as fire or hot liquids, who are admitted to the CHR Metz-Thionville burn center within 8 hours of injury. Written consent is required from the patient or a trusted person.
Who cannot participate: Patients without severe burns, those outside the specified age range, those not part of the specific trial groups, or those not covered by social security.
What the trial studies: The study measures how glucose is distributed in the body by taking blood samples before and after a small glucose injection. Researchers also monitor blood volume in the chest and water in the lungs using a special device called PiCCO.
Main goal: To better understand glucose distribution in severely burned patients, which may help improve treatment management in the future.
Study on the Effectiveness of EHSG-KF Skin Graft for Patients with Deep Partial and Full-Thickness Burns
This large international trial is taking place across eight countries: Germany, Poland, Belgium, Netherlands, Italy, Spain, France, and Portugal. It studies a new type of skin graft called denovoSkin™.
Who can participate: Patients at least 12 years old with deep partial or full-thickness burns covering at least 20% of their body. Informed consent must be signed by the patient or a legally authorized representative.
Who cannot participate: Patients with less severe burns, those outside the age range, those who cannot follow study procedures, or those with conditions that might interfere with the study.
What the trial studies: The denovoSkin™ graft is made from a bilayer engineered collagen hydrogel containing the patient’s own skin cells (keratinocytes and fibroblasts). This is compared to standard split-thickness skin grafts to see which method provides better wound healing and less scarring.
Main goal: To evaluate wound closure at 10 weeks and scar quality at 6 months, along with monitoring infection rates and overall healing progress. The study continues until 2028 to allow comprehensive data collection.
Study on the Safety and Effectiveness of EHSG-KF for Treating Deep Dermal and Full Thickness Burns in Children
This trial, conducted in Italy and the Netherlands, focuses specifically on treating children with severe burns using the EHSG-KF skin graft.
Who can participate: Children under 12 years old with deep partial thickness or full-thickness burns requiring surgical wound coverage. At least 90 square centimeters of the wound must be expected to remain open 4 weeks after the burn despite standard treatment. In the Netherlands, this does not include head and neck burns. Signed informed consent from parents or legal representatives is required.
Who cannot participate: Patients with infections at the burn site, autoimmune diseases, those who are pregnant or breastfeeding, those with uncontrolled diabetes, severe organ problems, those who received experimental treatment in the last 30 days, or those allergic to study materials.
What the trial studies: The EHSG-KF is a bio-engineered skin substitute made from the child’s own skin cells. The study compares this new treatment to traditional skin grafts taken from another part of the body.
Main goal: To assess safety and effectiveness by monitoring wound closure, infection rates, and scar quality over time, with evaluations at 4 weeks, 10 weeks, 3 months, 6 months, 12 months, and 24 months after treatment.
Study on the Effects of High-Dose Vitamin C in Patients with Severe Burns
This trial is conducted in Belgium, Germany, Italy, France, and Portugal, studying whether high-dose vitamin C can improve recovery in severely burned patients.
Who can participate: Adults 18 years or older with deep second and/or third-degree burns covering at least 20% of their body surface area and requiring skin grafting. Both men and women can participate.
Who cannot participate: Patients without severe burns, those outside the age range, or those not meeting specific trial group criteria.
What the trial studies: Participants receive ascorbic acid (vitamin C) through intravenous injection every six hours for 96 hours, in addition to standard burn care. The study compares this to a placebo to see if vitamin C makes a difference in recovery.
Main goal: To determine whether high-dose vitamin C can reduce the need for organ support (such as breathing machines or heart medications) and lower the risk of death within 28 days after injury. The study also monitors hospital discharge time and recovery without organ support.
Study on EHSG-KF for Treating Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents
This trial in the Netherlands studies the EHSG-KF treatment in older patients compared to the previous pediatric study.
Who can participate: Patients 12 years or older with deep partial thickness or full-thickness burns requiring surgical wound coverage. At least 90 square centimeters of the wound must be expected to remain open 4 weeks after the burn, even with standard treatment. Signed informed consent is required.
Who cannot participate: Patients with infections at the burn site, autoimmune diseases, those pregnant or breastfeeding, those with uncontrolled diabetes, severe organ problems, recent experimental treatment, allergies to study materials, or mental health conditions affecting their ability to follow instructions.
What the trial studies: Participants receive both the EHSG-KF treatment and standard split-thickness skin grafts on different areas, allowing direct comparison. The EHSG-KF is made from the patient’s own skin cells grown in a lab.
Main goal: To evaluate healing over time by measuring the area covered by the graft and scar quality, with assessments at 6-10 days, 21 days, 28 days, 90 days, and one year after treatment.
Study on Tranexamic Acid and Sodium Chloride for Reducing Blood Loss in Patients Undergoing Burn Surgery
This Netherlands-based trial focuses on reducing blood loss during surgery for burn patients.
Who can participate: Adults 18 years or older scheduled for burn excisional surgery with expected blood loss of 250 milliliters or more. Both men and women can participate.
Who cannot participate: Patients outside the specified age range or those considered part of vulnerable populations.
What the trial studies: Tranexamic acid is given intravenously during surgery to see if it can reduce blood loss and the need for blood transfusions. The medication works by helping prevent the breakdown of blood clots. Some participants receive tranexamic acid while others receive a placebo.
Main goal: To determine whether tranexamic acid can effectively reduce blood loss during surgery, decrease the need for transfusions, and improve surgical outcomes including skin graft success and overall recovery time.
Summary
The seven ongoing clinical trials for thermal burns reflect a diverse approach to improving burn treatment across Europe. A notable concentration of research activity is occurring in the Netherlands, which hosts four of the seven trials, including studies on skin grafts, blood loss reduction, and treatments for both children and adults.
Several trials focus on the innovative EHSG-KF skin graft technology, with studies designed for different age groups and conducted across multiple countries. This suggests significant interest in advancing skin graft treatments beyond traditional methods. The denovoSkin™ study is particularly notable for its broad geographic reach across eight European countries.
Other areas of investigation include infection prevention through antibiotic prophylaxis, metabolic support with glucose and vitamin C, and surgical blood loss management with tranexamic acid. These trials collectively aim to address various challenges in burn care, from immediate surgical concerns to long-term healing and scarring outcomes.
The trials include both adult and pediatric populations, reflecting the need for age-appropriate treatment approaches. Follow-up periods range from weeks to years, with some studies monitoring patients for up to 24 months to assess long-term outcomes such as scarring and functional recovery.
