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Why We Started Power

We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.

Bask
Bask GillCEO at Power
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      Clear All
      Why We Started Power

      We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.

      Bask
      Bask GillCEO at Power
      Learn More About Trials
      How Do Clinical Trials Work?Are Clinical Trials Safe?What Can I Expect During a Clinical Trial?

      77 Burns Trials Near You

      Power is an online platform that helps thousands of Burns patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

      Learn More About Power
      No Placebo
      Highly Paid
      Stay on Current Meds
      Pivotal Trials (Near Approval)
      Breakthrough Medication

      VR-PAT for Procedural Pain

      Columbus, Ohio
      This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased
      Age:6 - 17

      Key Eligibility Criteria

      Disqualifiers:Vision, Hearing, Cognitive Impairments, Others

      4 Participants Needed

      NovoSorb BTM for Severe Burns

      Columbus, Ohio
      This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
      No Placebo Group

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Hypersensitivity To Polyurethane, Multiple Traumas, Advanced Malignancy, Others

      150 Participants Needed

      Cohealyx for Full Thickness Wounds

      Columbus, Ohio
      The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Wound Infection, Immune Deficiency, Hypersensitivity, Others

      40 Participants Needed

      Virtual Reality Therapy for Burns

      Columbus, Ohio
      This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.
      No Placebo Group

      Trial Details

      Trial Status:Enrolling By Invitation
      Trial Phase:Unphased
      Age:6 - 17

      Key Eligibility Criteria

      Disqualifiers:Vision Impairments, Seizure Disorder, Pregnant, Others

      220 Participants Needed

      Vitamin C for Thermal Burns

      Ohio City, Ohio
      This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 3

      Key Eligibility Criteria

      Disqualifiers:Pregnancy, G6PD Deficiency, Kidney Stones, Others
      Must Not Be Taking:High-dose Vitamin C, Hydroxycobalamin

      666 Participants Needed

      PermeaDerm for Surgical Wounds

      Columbus, Ohio
      The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Morbid Obesity, Immunodeficiency, Diabetes, Others
      Must Not Be Taking:Corticosteroids, Chemotherapy, Immunosuppressants

      40 Participants Needed

      Insulin-Like Growth Factor 1 for Aging Skin

      Fairborn, Ohio
      This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Early Phase 1
      Age:21+

      Key Eligibility Criteria

      Disqualifiers:Photosensitivity, Diabetes, Abnormal Scarring, Others
      Must Not Be Taking:Photosensitizing Medications

      24 Participants Needed

      Albumin Human for Burns

      Cincinnati, Ohio
      This trial compares two ways of giving fluids to adults with severe burns. One way uses a mix of saltwater and protein solutions, while the other uses just saltwater. The goal is to see which way better maintains blood pressure and organ function by replacing lost fluids.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Significant Trauma, Electrical Burns, Pregnancy, Renal Insufficiency, Hepatic Disease, Others
      Must Not Be Taking:FFP, HTS, HES, Vitamin C

      400 Participants Needed

      Oxygen Therapy Strategy for Burns

      Cincinnati, Ohio
      The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
      No Placebo Group
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Phase 3

      Key Eligibility Criteria

      Disqualifiers:Age <18, Prisoners, Pregnancy

      2000 Participants Needed

      Targeted Oxygen Therapy for Critical Illness from Injuries

      Cincinnati, Ohio
      The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
      No Placebo Group
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Phase 3

      Key Eligibility Criteria

      Disqualifiers:Age <18, Prisoners, Pregnancy, Others

      6000 Participants Needed

      Plasma Resuscitation for Thermal Burns

      Pittsburgh, Pennsylvania
      The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 6-year (4-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resusciation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.
      No Placebo Group
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Phase 3

      Key Eligibility Criteria

      Disqualifiers:Age, Pregnancy, Traumatic Injury, Others

      750 Participants Needed

      Wound Healing Interventions for Chronic Wounds

      Pittsburgh, Pennsylvania
      This trial is testing different creams and ointments on patients with infected burn or chronic wounds. The goal is to see if these treatments help the skin heal better by keeping it moist and protected. Betadine cream and ointment have been used in burn treatment since 1986, showing substantial progress in healing rates. Patients will be monitored for several months to check their progress.

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Phase 1, 2

      Key Eligibility Criteria

      Disqualifiers:Marked Immunodeficiency, Prisoners, Others
      Must Not Be Taking:Immunosuppressants

      100 Participants Needed

      Thromboelastography for Burns

      Pittsburgh, Pennsylvania
      This pilot study examines the use of thromboelastography (TEG), a specialized blood test, to evaluate clotting abnormalities in burn patients. The study aims to understand how burn injuries impact the body's ability to form and break down blood clots over time. Specifically, the investigators will research whether the percentage of total body surface area burned (%TBSA) is associated with changes in blood clotting, track the evolution of clotting patterns during the first four weeks following a burn injury, and explore whether these changes can predict recovery or complications. By providing new insights into clotting dynamics in burn patients, the study seeks to improve diagnostic methods, enhance monitoring strategies, and guide treatments to optimize patient care and outcomes.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Venous Thromboembolism, Hyper/hypocoagulopathy

      50 Participants Needed

      Silver-Plated Technology for Radiation Dermatitis

      Pittsburgh, Pennsylvania
      Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Prior RT, Pregnancy, Connective Tissue Disorders, Others

      17 Participants Needed

      Fat Grafting for Burns

      Pittsburgh, Pennsylvania
      The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive immediate fat grafting into the wound. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Active Infection, Pregnancy, Others

      68 Participants Needed

      Autologous Fat-Based Therapy for Scar Tissue

      Pittsburgh, Pennsylvania
      The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive fat grafting at time of scar revision. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Active Infection, Pregnancy, Others

      40 Participants Needed

      Physical Therapy for Burns

      Indianapolis, Indiana
      The objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased
      Age:18 - 65

      Key Eligibility Criteria

      Disqualifiers:Renal Failure, Cognitive Disorders, Brain Injury, Others

      166 Participants Needed

      Transforming Powder Dressing for Burns

      Louisville, Kentucky
      This trial is testing a special powder that turns into a protective layer for treating recent partial thickness burns in adults. The goal is to see if it helps burns heal faster and reduces pain compared to other treatments.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 4
      Age:18 - 65

      Key Eligibility Criteria

      Disqualifiers:Pregnancy, Infected Wounds, Full Thickness Burns, Electrical Burns, Alcohol/substance Abuse, Others

      60 Participants Needed

      Acute Normovolemic Hemodilution for Cardiac Surgery

      Charlottesville, Virginia
      Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.
      No Placebo Group

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Unstable Coronary Artery Disease, Pregnancy, Emergency Surgery, Others

      2000 Participants Needed

      FS2 for Scarring from Burns

      Hamilton, Ontario
      The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.
      No Placebo Group
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 2, 3
      Age:18 - 60

      Key Eligibility Criteria

      Disqualifiers:Pregnancy, Heavy Smoking, Heavy Drinking, Severe Depression, Others

      70 Participants Needed

      Why Other Patients Applied

      "I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

      AG
      Paralysis PatientAge: 50

      "I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

      WR
      Obesity PatientAge: 58

      "I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

      ZS
      Depression PatientAge: 51

      "As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

      IZ
      Healthy Volunteer PatientAge: 38

      "My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

      HZ
      Arthritis PatientAge: 78
      Match to a Burns Trial

      Metformin for Burns

      Hamilton, Ontario
      This trial is testing if metformin, a diabetes medication, can help elderly burn patients recover better by controlling blood sugar and reducing inflammation and metabolic stress. Metformin is widely used for diabetes and has shown potential benefits beyond controlling blood sugar, including reducing inflammation.

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Phase 2
      Age:60 - 99

      Key Eligibility Criteria

      Disqualifiers:Renal Failure, Severe Liver Disease, Others
      Must Not Be Taking:Insulin

      250 Participants Needed

      Cellularized Integra® for Burns

      Hamilton, Ontario
      Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Phase 1

      Key Eligibility Criteria

      Disqualifiers:HIV, Hepatitis B, Pregnancy, Others

      29 Participants Needed

      New Dressing for Burns

      Hamilton, Ontario
      The goal of this clinical trial is to test a novel donor site dressing called Product X in burn patients requiring skin grafting procedures. A donor site is an area where the surgeon has taken a layer of skin to create a graft. This is required to make severe burn wounds heal. However, donor sites often experience infection, pain, and itch that can delay the healing of the donor site. To prevent these complications, donor sites are covered with dressings to prevent infection and absorb fluids from the wounds. Many options exist, but no single dressing is best, especially for pain management and the ability to absorb fluids from wounds effectively. The investigators have developed a new donor site dressing to meet the criteria of an "ideal dressing," called Product X. The main question this clinical trial aims to determine the safety and potential wound-healing benefits of this donor site dressing as a new therapy that will help patients who require donor sites. Participants will: * Be randomized, like a flip of a coin, to receive either Product X or the standard-of-care dressings. If patients have one donor site, it will be randomized to receive either Product X or the standard-of-care dressings, Allevyn and Xeroform. If they have two donor sites, one donor site will be randomized to receive Product X and the other to receive standard-of-care dressings. * Have photographs of their donor sites taken at the operation, during dressing changes, at discharge, and at regularly scheduled outpatient follow-up appointments with the burn clinic. * Complete short questionnaires to assess their comfort (pain and itch) with their donor sites daily. * Complete a scar formation questionnaire at your regularly scheduled follow-up appointments in the outpatient burn clinic. Researchers will compare Product X to standard-of-care dressings (Allevyn and Xeroform) to see if there are improvements in wound healing, pain, itch, and infection.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Moribund, Pregnancy, Active Cancer, Others

      40 Participants Needed

      KeraStat Cream for Radiation Dermatitis in Head and Neck Cancer

      Winston-Salem, North Carolina
      The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Early Stage Cancer, Previous Radiation, Scleroderma, Lupus, Pregnancy, Others
      Must Not Be Taking:Topical Corticosteroids, Anti-EGFR Biologics

      16 Participants Needed

      Automated Oxygen Titration for Critical Illness

      Winston-Salem, North Carolina
      This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Pregnancy, Prisoner, Pneumothorax, Others

      300 Participants Needed

      Oxytocin for Sunburn Pain

      Winston-Salem, North Carolina
      This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 2
      Age:18 - 55

      Key Eligibility Criteria

      Disqualifiers:Skin Cancer, Diabetes, Hyponatremia, Others
      Must Not Be Taking:Benzodiazepines, Pain Medications, SSRIs, MAOIs

      36 Participants Needed

      Skin Substitute for Burns

      Toronto, Ontario
      This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
      No Placebo Group

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 1, 2

      Key Eligibility Criteria

      Disqualifiers:Connective Tissue Diseases, Immunodeficiency, Diabetes, Others

      52 Participants Needed

      Peer Support Program for Traumatic Injury

      Toronto, Ontario
      Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet. Peer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living. The investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.
      No Placebo Group

      Trial Details

      Trial Status:Not Yet Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Not Listed

      49 Participants Needed

      Topical Betamethasone for Prevention of Radiation Induced Dermatitis

      Toronto, Ontario
      Radiotherapy (RT) is common in the treatment of breast cancer, however, 95% of breast cancer patients are at risk of developing acute and chronic skin toxicities known as radiation dermatitis (RD) which includes symptoms such as pruritus, edema, erythema, and moist desquamation (MD). Patients with a larger breast size are especially at risk of developing RD. The severity of RD can impact patient's quality of life (QOL) and their ability to complete treatment. Skin care guidelines for patients receiving RT vary and include barrier films and dressings, antibiotics, topical corticosteroids, and moisturizers. A study conducted at the Sunnybrook Odette Cancer Centre investigated the effectiveness of the prone treatment position during RT compared to the supine position. The results indicated that the prone position reduced the incidence of MD from 39.6% in supine to 26.9% in prone. However, 1 in 4 patients in the prone position still develop MD. Another study conducted at Sunnybrook Odette Cancer Centre found that Mepitel Film (MF), a barrier film, is more effective than the standard of care in preventing grade 2 or 3 RD, reducing the incidence of grade 2 or 3 RD from 45% to 15%. Despite its effectiveness, MF cannot be used for patients in the prone position and is costly. The topical corticosteroid betamethasone can prevent skin toxicity through its anti-inflammatory properties and is absorbed by the skin with minimal side effects. Betamethasone is cost-efficient and studies have found that it is effective in reducing the severity of RD in the supine position by half. Moreover, betamethasone can be applied in patients positioned in both prone and supine. The investigators hypothesize that adding betamethasone in large-breasted patients treated in prone during RT will further reduce RD. This randomized control trial is the first of its kind to aim at investigating the effectiveness of betamethasone when compared with the standard of care in reducing the severity of RD in large-breasted patients being treated in the prone position during RT. The investigators will enroll 276 breast cancer patients with band size ≥ 40 or ≥ D cup to be randomized to receive 0.1% betamethasone cream or the standard of care in a 2:1 ratio (alpha = 5% and power = 80% with the hypothesis that the addition of betamethasone to prone reduces the severity of RD from 30% to 15%). Upon enrolment, stratification factors will be recorded, and patients will be randomized into trial arms using procedures that balance stratification factors. All eligible patients will be stratified according to the following factors: patients receiving conventional RT (50Gy/25#) versus hypofractionated RT (40Gy/15#) versus extreme-hypofractionated RT (26Gy/5#), whole or partial breast radiation, patients with Fitzpatrick skin type VI versus patients with Fitzpatrick skin type I-V, patients receiving a planned boost versus patients without planned boost. The CRA will be responsible for collection of assessments and photos from patients. Patients will use the assigned cream daily during RT treatment and up until 2 weeks after RT. The primary endpoint of this study is acute grade 2 or 3 toxicities as defined by the Common Terminology Criteria for Adverse Events v5.0. Secondary endpoints will include patient- and clinician-reported outcomes as assessed by the Skin Symptom Assessment and the Radiation-Induced Skin Reaction Assessment Scale. Moreover, the investigators will also employ a QOL tool, the Skindex-16, and a Patient Satisfaction Questionnaire. Patients will complete assessments weekly during RT and 2 weeks post-RT in person, followed by 6 weekly assessments and a 3-month telephone follow-up post-RT. Clinicians will assess patients weekly during RT and at the 2-week follow-up appointment.
      No Placebo Group
      Pivotal Trial (Near Approval)

      Trial Details

      Trial Status:Recruiting
      Trial Phase:Phase 3

      Key Eligibility Criteria

      Disqualifiers:Brachytherapy, Bilateral Radiation, Active Rash, Others
      Must Not Be Taking:Cytotoxic Chemotherapy

      276 Participants Needed

      StrataXRT for Radiation Burn

      Toronto, Ontario
      For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. In a study published it was found that for women with large breasts (n=357), being positioned in the supine position during radiation could lower the rates of moist desquamation from 36.9% in the supine position down to 26.9% when treated in the prone position. Even though the prone position for patients with large breasts did reduce rates of moist desquamation, these results demonstrate that one in five patients still go on to develop severe reactions, even in the prone position. Building on these results, a phase II feasibility study conducted at Sunnybrook, found that the use of a silicone-based film forming topical gel known as StrataXRT could lower the incidence of moist desquamation for patients treated in the prone position even further.
      No Placebo Group

      Trial Details

      Trial Status:Active Not Recruiting
      Trial Phase:Unphased

      Key Eligibility Criteria

      Disqualifiers:Previous Radiation, Active Rash, Others
      Must Not Be Taking:Cytotoxic Chemotherapy

      20 Participants Needed

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      Frequently Asked Questions

      How much do Burns clinical trials pay?

      Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

      How do Burns clinical trials work?

      After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Burns trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Burns is 12 months.

      How do I participate in a study as a "healthy volunteer"?

      Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

      What does the "phase" of a clinical trial mean?

      The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

      Do I need to be insured to participate in a Burns medical study?

      Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

      What are the newest Burns clinical trials?

      Most recently, we added VR-PAT for Procedural Pain, Tele-exercise for Motor Skills Affected by Toxic Exposures and Plasma Resuscitation for Thermal Burns to the Power online platform.