36 Clinical Trials for Various Conditions
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves * Treatment problems can require more grafting * Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
The goal of this study is to develop a safe, effective, and readily available treatment that will prevent chronic pain following Major Thermal Burn Injury (MThBI). Burn survivors are prone to develop chronic pain and there is an urgent unmet need for preventative treatments. The preventative treatments proposed for this study, Omega-3 Fatty Acids (O3FA) and Vitamin D have been selected given effectiveness across a range of painful musculoskeletal disorders and their wide availability and low cost. This study is a 2x2 factorial, double-blind, placebo-controlled randomized controlled trial test for the effectiveness of O3FA and Vitamin D to prevent chronic pain development. Burn survivors will be enrolled who have experienced thermal burns that cover less than 30% total body surface area that are severe enough to warrant surgical management, which represents the most common burn injury characteristics. Patients will be enrolled within 72 hours of their burn, and randomized via 1:1:1:1 allocation to receive placebo, O3FA, Vitamin D or both. The investigators will obtain blood samples on enrollment and at 6 weeks to assist in elucidating key mechanisms by which O3FA and Vitamin D reduce chronic pain following MThBI. Chronic pain severity, assessed with a 0-10 numeric rating scale at 6 weeks, 3 months, 6 months and 1 year will be entered into a repeated-measures model. Model estimated contrasts will serve as the primary outcome.
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat. The burns will: * be on 3-49% of the participant's total body surface area (TBSA) * require surgery for skin replacement * include intact dermal elements The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged. The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin. All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one. This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
The objective of the study is to assess the logistical and biological feasibility of preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using the Celution® System for autologous, same-day application to the burn wound.
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 5% TBSA. Enrolled subjects must have at least 1% TBSA deep partial-thickness burns. Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times. Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing. Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization). Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal. MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites). The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care. The BLA assessment was completed and NexoBrid is approved for use in adults in the US. Adult enrollment is closed, and only pediatric patients will continue to be recruited for this treatment protocol. The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA. This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
The objective of the study is to analyze the different implications (such as graft loss and conversion of indeterminate depth burns) of biofilm infections in burn patients. Additionally, it also aims at comparing children's resistance to biofilm infection at wound site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.
This is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for reconstruction with Integra®. Subjects would have a small area of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125 cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small portion of the patient's area of injury. The remaining injury areas would be covered with standard-thickness Integra® only.
The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.
The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.
To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.
The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic properties of the subcutaneous burned tissue. Data collected in this study will lead to the development of better diagnostic tools that could inform clinical burn practices by enabling doctors to determine burn depth and the need for surgery with greater speed and accuracy, resulting in better clinical outcomes.
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.
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.
The objective of this study is to determine whether our chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.
The purpose of this study is to test the following hypotheses: 1. Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden. 2. Early use of WSD on partial-thickness burn wounds will result in faster healing. 3. Use of WSD on partial-thickness burn wounds will result in less painful wound care. 4. Early use of WSD on partial-thickness burn wounds will result in less infection. 5. Early use of WSD on partial-thickness burn wounds will result in lower hospital costs.
There have been multiple articles done regarding oral hygiene on patients in burn and intensive care patients. All articles agree the need for good oral hygiene in these special needs patients. They also note that more research needs to be done on this subject, yet have no direction of how to proceed in this research. Currently, no research has been done on the burn/intensive care patient to see if there is a difference form the non-hospitalized patient which oral hygiene protocol is based on.
Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and proliferation of cells responsible for wound repair and it augments production of granulation tissue. The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III and IV. The nature of wounds in the third degree burns is similar so far as healing process is concerned. The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01% gel on the third degree thermal and electrical burns will heal these wounds within 3 months and there will be improvement in general condition of the patients without any complications.
The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. The prototype LIMB device will be evaluated for the occurrence of adverse events (treatment-related or otherwise) of the LIMB System, a portable, wearable, light-emitting system developed by Rogers Sciences, Inc. (RSI). The device will be administered in the small feasibility pilot to confirm design, usability and operating specifications that will inform procedures and endpoints of a subsequent large, multicenter clinical trial.
Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with keeping burn patients comfortable, especially when these patients undergo dressing changes of their burn wounds of their skin since these procedures often cause severe pain. Patients with burn wounds frequently require high doses of opioids (narcotics) and calming (anxiolytic) agents to the extent that clinicians must weigh the risks associated with these doses against achieving adequate analgesia and comfort. The biggest risk is over-sedation to cause breathing troubles. Inadequate pain control during these procedures heightens pain perception, anxiety, and fear surrounding the experience and may lead to patients experiencing additional psychological disorders like depression, acute stress disorder (ASD), and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better management of pain and anxiety during these procedures need to be identified. This study will address whether the addition of ketamine during dressing changes improves patients' pain control and comfort and whether this leads to favorable psychological outcomes. The study is designed to compare ketamine with placebo when they are added to usual care (opioids and anxiolytics) during dressing changes. The main outcomes of the study will be the amount of opioid and anxiolytic agents each group receives during their procedure; the presence of pain-related anxiety shortly after the procedures; blood markers of stress during the procedures; and the presence of depression, anxiety and stress disorders prior to discharge. This study will assess whether the early administration of ketamine reduces pain and anxiety to prevent the need for high doses of opioids and anxiolytics. A total of 30 patients will be enrolled.
Specific Aim 1: To determine if one of three burn dressings provides a less painful healing experience for partial thickness hand. Specific Aim 2: To evaluate if one of three dressings provides greater functionality during and after healing of partial thickness hand burns. Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds. The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.
Animal and human data have supported the notion that administration of large doses of Vitamin C has beneficial effects on those subjects suffering from large burns. This effect may be due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C. These studies have demonstrated an improvement in urine output during resuscitation and reduced need for fluid volumes during resuscitation. In turn, these subjects demonstrated a reduction of wound edema, improved respiratory status (demonstrated by improvements in P:F ratios and reduced ventilator days), and no differences in terms of the possible complications of high-dose vitamin C administration between standard and treatment groups. The purpose of this study is to prospectively determine if Vitamin C can be safely used as an adjunctive treatment for patients suffering severe thermal injuries. High-dose vitamin C administered at a dose of 66mg/kg/hr during the acute phase of severe burn injuries will reduce fluid requirements in the first 48 hours after injury.