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Showing 1-20 of 189 trials
NCT06921707
The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.
NCT07530003
To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.
NCT06992895
The process of dressing burn injuries has been shown to cause both physical and psychological difficulties. In children, this process is particularly associated with intense pain and anxiety. Consequently, in addition to pharmacological interventions, non-pharmacological methods such as distraction are employed. In recent years, the utilization of holograms as a method of alleviating pain has emerged as a novel approach. The employment of these visual illusions has been demonstrated to effectively distract children, thereby providing a means of reducing discomfort. The objective of this thesis is to evaluate the effects of hologram application on pain, anxiety, fear, and vital signs during burn dressing in children.
NCT07169448
The purpose of this study is to examine the impact of a medically tailored post-operative meal delivery program on surgical outcomes and metabolic lab markers in orthopaedic trauma patients. Patients will have 12 days of meals and shakes delivered to their house through our partnership with Meals on Wheels. Metabolic lab values will be drawn at the 2 week and 6 week post-op visits. All patients will be followed for up to 1 year postoperatively.
NCT07463378
This is a Phase 1 research study evaluating the safety and potential benefits of a topical gel called LUT017 in helping skin wounds heal after minor skin procedures. The study will enroll healthy adults who are already scheduled to have two benign (non-cancerous) skin lesions, such as moles, removed as part of routine care. When the lesions are removed, two small wounds will be created. One wound will be treated with LUT017 gel, and the other will be treated with a placebo gel that does not contain active medication. This allows each participant to serve as their own comparison. The study team will monitor how the wounds heal over approximately one week using clinical evaluation, photographs, and safety assessments. LUT017 is a topical medication designed to activate natural skin repair pathways and potentially promote faster healing. The main purpose of this study is to determine whether a single application of LUT017 gel is safe and well tolerated when applied to fresh skin wounds, and to look for early signs that it may improve or speed up wound healing compared to placebo. The primary question this study aims to answer is: Is LUT017 gel safe when applied to acute skin wounds, and does it show preliminary evidence of improving early wound healing in healthy adults? Participants will be followed for about one week after treatment, with blood tests and skin evaluations to monitor for any side effects. The information gathered from this study will help determine whether LUT017 should continue to be developed as a potential treatment to support wound healing.
NCT04872400
The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.
NCT02932176
The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous in clinical practice. However, most users have received no formal training in their use or the interpretation of the returned data. This leads to delays in diagnosis and errors in diagnosis. The investigators intend to create a novel machine-learning algorithm to assist clinicians in the use of this data. This study will allow the investigators to collect sound files from the use of the devices and compare the algorithms output to established, existing vascular testing. There will be no invasive procedures, and use of these stethoscopes is part of routine clinical care. If successful, this data and algorithm will be later deployed via smartphone app for point of case testing in a separate study
NCT07451990
This randomized controlled trial compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Adult patients undergoing elective midline laparotomy were randomly assigned to rectus sheath closure using either Prolene or Vicryl sutures. All patients received the same standardized surgical technique and postoperative care. Participants were followed for 30 days after surgery to assess wound healing, wound dehiscence, surgical site infection, and length of hospital stay. The study aimed to determine which suture material is associated with fewer postoperative wound complications.
NCT06596434
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.
NCT07437586
This study will evaluate whether a topical gel containing GHK-Cu (a copper(II)-peptide complex) can safely speed up healing of small, standardized skin wounds in healthy adults compared with a matching vehicle gel. Participants will receive two small punch-biopsy wounds on the upper arm; each wound will be randomly assigned to receive GHK-Cu gel or vehicle gel under identical dressings. Wounds will be photographed and assessed over 3 weeks, with a follow-up visit to evaluate scar quality.
NCT07421934
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds. The investigational device consists of high molecular weight sodium hyaluronate (2500-3500 kDa), obtained through bacterial fermentation, combined with amino acids (L-proline, L-hydroxyproline, glycine, and L-lysine HCl), formulated at a concentration of 25 mg/ml. The device is designed to promote wound healing through the hydrating and film-forming properties of hyaluronic acid, creating a favorable microenvironment for re-epithelialization and tissue regeneration. The study is sponsored by The Wave Innovation Srl and conducted at the Oral Surgery and Stomatology Unit of the Azienda Ospedaliera Universitaria Luigi Vanvitelli, under the scientific responsibility of Prof. Luigi Laino. No additional costs are foreseen for the National Health Service, and no compensation is provided to investigators. The primary objective of the study is to assess the safety and clinical performance of the device in improving the healing of post-surgical oral wounds. The main outcomes include improvement in the Clinical Healing Score (CHS)-a clinical score assessing redness, edema, suppuration, healthy granulation tissue, and signs of re-epithelialization-the rate of wound closure evaluated through morphometric analysis, and the incidence of adverse events. The study population consists of adult patients requiring extraction of at least two teeth. For each patient, two surgical sites are identified: one treated with the hyaluronic acid-based device and one serving as an internal control, allowing for direct intra-patient comparison. The device is injected into the post-extraction socket prior to suturing or applied to the adjacent soft tissues. The study design includes a screening visit (Visit 0), a surgical treatment visit (Visit 1), and three follow-up visits at 7, 14, and 30 days after treatment completion (Visits 2, 3, and 4). During follow-up visits, the Clinical Healing Score, wound closure via morphometric analysis, and the occurrence of any adverse events are assessed. Inclusion criteria include adult patients in good systemic and oral health, able to comply with study procedures, and who have provided written informed consent. Exclusion criteria include factors that may interfere with wound healing, such as smoking more than 10 cigarettes per day, recent oncological therapies, recent antibiotic therapy, bisphosphonate treatment, pregnancy or breastfeeding, and acute infection at the surgical site. Safety is evaluated through the recording and classification of all adverse events (AEs) and serious adverse events (SAEs), in accordance with applicable regulations and Good Clinical Practice (ISO 14155). Risks associated with the use of the device are considered minimal and mainly related to the surgical procedure itself. Based on extensive scientific literature supporting the use of hyaluronic acid in oral wound healing, the overall risk-benefit profile is considered favorable. The study is conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and Regulation (EU) 2017/745 on medical devices.
NCT06968546
Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients. Intranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally. The aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children. Children who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment. The hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care. The results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.
NCT06321419
Rationale: Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials. Aim: To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients. Trial Population: Adult trauma patients presenting to the emergency department of a participating hospital. Eligibility Criteria: Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission. Ethical Considerations: The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records. Funding: Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297). Special considerations: This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those.
NCT07335861
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
NCT07337616
This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.
NCT06760611
An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.
NCT07316556
This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended purpose and certified indications during routine use, and to gather additional safety data. The study will examine how the use of the dressing affects the condition of the skin surrounding the wound, the wound status in terms of exudate, wound odor, and other parameters. Furthermore, the satisfaction of healthcare providers and patients with the application of the dressing will be assessed.
NCT07312513
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
NCT04387305
Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.
NCT07257991
The goal of this clinical trial is to learn if povidone-iodine foam dressing is better in achieving complete reepithelialization of donor site wounds after harvest of split-thickness skin graft as paraffin mesh gauze. The main questions it aims to answer are: Does povidone-iodine foam dressing promotes complete reepithelialization earlier in comparison? Which type of dressing will require fewer replacements? Which type of dressing material is associated with less pain? Non-probability consecutive sampling method will be used and participants divided in two groups. Donor site wounds after split-thickness skin graft harvest will be dressed using two different dressing materials. Participants will be followed until complete epithelialization with change of dressing on follow-ups if required. Complete epithelialization is usually achieved within two weeks.