Burn injuries involve damage to the skin and underlying tissues and require careful management to support healing and function. Clinical trials related to burn care explore a range of topics including treatment evaluations for wound healing and infec...

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Found 73 Actively Recruiting clinical trials

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Many people experience wounds that do not heal well or take a long time to heal, including both chronic and acute wounds. This research aims to study the effects of 4-aminopyridine (4-AP), a drug currently used in neurological conditions, to see if it can help speed up wound healing in healthy adults. Previous animal studies showed promising results with faster healing and no adverse effects, making it important to evaluate 4-AP's role in human wound repair. Participants in this study will be randomly assigned to receive either 4-aminopyridine capsules or placebo capsules taken every 12 hours. The treatment period lasts for 6 weeks, during which researchers will monitor wound healing progress. The study includes a phase where participants receive either the active drug or placebo to compare effects on skin integrity and wound closure. During the study, participants will have a skin punch biopsy wound that will be monitored for healing over 6 weeks. Researchers will assess the return of skin integrity, wound closure, and hair growth at the biopsy site. Participants must attend scheduled follow-up visits and may be asked to provide wound photographs. The study also tracks safety and tolerability, ensuring participants are able to report any sensory or motor changes. Total participation is about 6 weeks with regular evaluations.

Age: 18Years - 70YearsAll GendersPhase 2
1 location
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Actively Recruiting

Many patients suffer from traumatic burns, and current treatments mainly focus on infection prevention and fluid management without improving the skin's ability to regenerate. This research aims to evaluate the role of 4-aminopyridine (4-AP), a promising agent with a good safety profile, in accelerating burn wound healing in patients with second-degree burns. The study addresses the need for new regenerative treatments that can speed up recovery while allowing existing protocols to continue. Participants will be randomly assigned to receive either 4-aminopyridine capsules (10 mg every 12 hours) or a placebo capsule on the same schedule. This phase 2 study will compare these two groups over a 12-month period to assess the treatment's effect on the healing process. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for healing rate, skin graft requirements, scar formation, and scar sensitivity over 12 months. They will provide informed consent and attend scheduled follow-up visits where researchers will evaluate wound healing through sensory and motor assessments and calibrated wound photographs. Safety and adherence will be closely tracked to evaluate the treatment's impact and patient outcomes throughout the study period.

Age: 18Years +All GendersPhase 2
1 location
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Actively Recruiting

Burn injuries can cause long-lasting physical and mental effects due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the depth of the burn, followed by surgery for deeper burns. Assessing burn depth is difficult, and surgical removal of damaged tissue may remove some healthy tissue. New methods like hydro-dissection devices and enzymatic treatments like Bromolein have been explored but lack clear proof of benefit and may sometimes cause harm. This research compares PluroGel®, a special gel that helps soften and remove dead tissue while keeping the wound moist, to the standard antibiotic ointment and gauze dressings. PluroGel® is applied in a 0.5 cm layer with moist gauze twice daily, alongside the standard dressing applied three times a week. The study will assess if PluroGel® improves wound healing and reduces the need for surgery. Participants will receive either the standard dressing or PluroGel® treatment and will be followed for up to 14 days. Researchers will monitor wound healing, pain levels, satisfaction of patients and caregivers, and whether surgery is needed. The study uses a randomized, double-blind design and aims to provide evidence on the effectiveness of PluroGel® in burn care.

Age: 18Years +All GendersPhase 1Phase 2
1 location
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Actively Recruiting

Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits: a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.

Age: 18Years +All GendersPhase Not Applicable
3 locations
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Actively Recruiting

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers (VLU) and diabetic foot ulcers (DFU), using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits: a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

Age: 18Years +All GendersPhase Not Applicable
4 locations
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Actively Recruiting

Researchers are evaluating the use of disposable nitrous oxide canisters to provide better pain control during burn dressing changes. Despite advances in burn care, managing pain during routine wound care remains challenging due to the high doses of narcotics required and their potential side effects. This pilot randomized controlled crossover trial aims to test if nitrous oxide, a rapidly acting analgesic, can improve pain relief compared to placebo in adult burn patients. Participants will receive nitrous oxide inhalant or placebo canisters during burn dressing changes. Nitrous oxide acts within seconds and provides pain relief lasting minutes, making it potentially suitable for short but intense pain episodes like dressing changes. The study compares pain and anxiety levels when using nitrous oxide versus placebo, with treatments administered in a double-blinded and randomized manner. Participants will be assessed for pain and anxiety using the Burn Specific Pain Anxiety Scale and Visual Analogue Scales before, during, and after dressing changes. Researchers will also monitor the use of additional anxiolytics at these time points. The study enrolls adult burn patients with 5-20% body surface area burns and excludes those with serious respiratory or cardiovascular conditions or those unable to use the inhalant. The trial is led by the University of Manitoba and started in 2019, continuing until 2029.

Age: 18Years +All GendersEarly Phase 1
1 location
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Actively Recruiting

Burn injuries can cause long-lasting physical and mental challenges due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the burn depth, followed by surgery for deeper burns. Assessing burn depth is complex and can take weeks, with surgical removal of tissue often removing some healthy tissue. New methods like hydro-dissection devices and enzymatic debridement have been explored but lack definitive proof of benefit and may sometimes cause harm. This trial is studying PluroGel®, a gel that helps clean burn wounds by loosening and removing dead tissue while keeping the wound moist. Participants will receive either the standard antibiotic ointment and gauze dressing or PluroGel® plus the standard dressing with moist gauze. Dressings are applied every Monday, Wednesday, and Friday, with moist gauze kept wet twice daily in the PluroGel® group. This is a randomized, double-blind study comparing these two approaches. Participants will be monitored to see how much of the burn heals within 14 days and whether surgery is needed during this time. The study includes regular dressing changes and wound evaluations. The trial aims to gather evidence on the healing effects of PluroGel® compared to standard care over this two-week period. Participation lasts at least 14 days, with close follow-up to assess wound healing and treatment safety.

Age: 18Years +All GendersPhase 1Phase 2
1 location
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Actively Recruiting

Partial thickness burns are the most common type of burn injury, typically treated with two weeks of topical therapy and wound care. If the burn wound does not heal within this period, surgical excision and skin grafting may be required. Researchers are exploring the use of Modulated Imaging and Laser Speckle Imaging as additional tools to assess burn wound severity and healing potential alongside standard clinical evaluation. This study uses two noninvasive imaging methods: Modulated Imaging, which measures the metabolic functions of the burn wound, and Laser Speckle Imaging, which measures blood flow in the wound. These imaging techniques are compared with the current standard of care and clinical exams to gather information on wound healing time and treatment outcomes. Participants with burn wounds will undergo imaging with these devices to assess their wounds. Researchers will measure burn wound severity noninvasively within one day. The study involves both inpatients and outpatients, and researchers will collect data on healing progress to evaluate the usefulness of these imaging technologies in managing burn wounds. The study may continue until February 2030.

Age: 1Minute +All Genders
1 location
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Actively Recruiting

Researchers are studying the outcomes of adults with severe burns covering more than 30% of their total body surface area. The study focuses on how albumin administration during the first 24 hours of burn resuscitation may impact prognosis, including risks like organ failure and mortality. This observational study aims to collect detailed data on patient outcomes to help design future interventional trials evaluating albumin's role in burn care. Participants are adults aged 18 to 80 years admitted to intensive care units within 12 hours of severe burns. The study observes current management practices, including how albumin is given, such as dose, duration, and method of administration. The research follows patients for 90 days after admission to track their health and treatments. During the study, researchers will monitor combined outcomes of death, severe acute kidney failure, and serious respiratory distress within 28 days after the burn injury. They will also assess rates of kidney failure, respiratory distress, abdominal complications, sepsis, and organ function scores up to 90 days post-injury. This thorough follow-up helps understand how albumin use relates to recovery and complications in severe burn patients.

Age: 18Years - 80YearsAll Genders
1 location
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Actively Recruiting

Researchers are investigating whether giving systemic antibiotics before surgery can lower the risk of infections after excision-graft surgery in burn patients. This study focuses on adults with burns covering 5% to 40% of their body surface area who require at least one excision surgery graft. The question arises because antibiotic use carries risks like antibiotic resistance and side effects, and current guidelines on prophylactic antibiotics in burn surgery vary widely without clear consensus. Participants are randomly assigned to receive either antibiotic prophylaxis or a placebo before surgery. If their burned area is not colonized by Pseudomonas aeruginosa, they receive cefazolin 2g by intravenous infusion over 30 minutes. If colonized by Pseudomonas aeruginosa, they receive piperacillin-tazobactam 4g in the same way. The control group receives a saline placebo infusion. Antibiotics or placebo are administered 30 minutes before the surgical incision. During the study, patients are monitored in intensive care or burn centers where vital signs, infection scores, medical history, treatments, and bacterial colonization are recorded. Follow-up visits occur at 7, 28, and 90 days after surgery to track infections, graft outcomes, hospital stay length, and antibiotic use. The primary focus is on infections and graft problems within 7 days post-surgery, with longer-term follow-up by phone or medical team contact if discharged. The study duration per patient is up to 90 days.

Age: 18Years - 99YearsAll GendersPhase 3
1 location

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