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Burns clinical trials

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NCT ID: NCT05796492 Recruiting - Burn Wound Clinical Trials

Ultrasound Treatment on Wound Healing Time

GE-MTEC
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls).

NCT ID: NCT05749003 Recruiting - Clinical trials for Lower Extremity Burns

Sensorimotor Training Exercise After Lower Extremity Burns

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. Impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. Balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. Therefore, to guide recovery accurately and facilitate rehabilitation after LLBI, multi-factorial assessment is required.

NCT ID: NCT05729529 Recruiting - Clinical trials for Burning Mouth Syndrome

Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease.

NCT ID: NCT05652816 Recruiting - Burn Degree Second Clinical Trials

Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients

Start date: September 6, 2022
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is: • Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft? You will: - Undergo debridement surgery - Receive artificial skin graft as an alternative to autologous skin graft - Undergo biopsy procedure of burn area If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process

NCT ID: NCT05629091 Recruiting - Burns Clinical Trials

An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns

Start date: August 12, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex® for treatment of superficial dermal burns in paediatric and adult patients. The clinical performance and safety of FibDex® will be compared to Epicitehydro (QRSKIN GmbH, Würzburg, Germany) and Epiprotect® (S2Medical AB, Linköping, Sweden). Epicitehydro is considered to be the primary comparator. The investigation will be conducted at 2 clinical research sites in Sweden.

NCT ID: NCT05625503 Recruiting - Pain Clinical Trials

Dilution of Verapamil During Intraarterial Administration

Start date: December 13, 2022
Phase: Early Phase 1
Study type: Interventional

This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups: 1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline 2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL) The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.

NCT ID: NCT05619289 Recruiting - Chronic Pain Clinical Trials

Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question[s] it aims to answer are: - Is the clinical trial protocol feasible? - Is Vitamin D administration following burn injury safe? - How does vitamin D cause changes in the immune system in the aftermath of burn injury? Following informed consent, participants will be asked to: - Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo) - Provide a blood sample at baseline and 6 weeks following injury - Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months. Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.

NCT ID: NCT05559489 Recruiting - Burn Shock Clinical Trials

Enteral Resuscitation Nepal

Start date: December 8, 2022
Phase: Phase 3
Study type: Interventional

Nepal and the South Asian sub-continent carry some of the highest rates of burn injury globally, with associated high morbidity and mortality. Nepal currently has one major center equipped for comprehensive burn care, in Kirtipur, Nepal, and receives patients who are referred from around the country. At the time of presentation, most patients with major burns have had minimal to no resuscitation on arrival, and often present hours to days after the burn injury was sustained. Timely fluid resuscitation, initiated as soon as possible after a major burn injury, is the main tenet of acute burn care. Lack of adequate resuscitation in major burn injuries leads to kidney injury, progression of burn injury, sepsis, burn shock, and death. The current standard of care for major burn resuscitation is intravenous fluid resuscitation. However, in low- and middle-income countries such as Nepal, adequately trained and equipped hospitals for the treatment of burn care are not widely available (for a variety of reasons). Additionally, there is no systematic emergency medical transport system available to provide medical care and resuscitation during transport. Enteral-based resuscitation-drinking or administering fluids via the gastrointestinal tract-with substances like the WHO Oral Rehydration Solution (ORS) is recommended by burn experts and professional burn societies when resources and access to intravenous fluid resuscitation are not available. Studies have previously demonstrated the efficacy and safety of enteral-based resuscitation in controlled, high-resource settings, however, there have not been real-world effectiveness trials in resource-constrained settings. Therefore, the investigators seek to ultimately address the problem of pre-hospital and pre-burn center admission resuscitation by studying the effectiveness of enteral resuscitation with Oral Rehydration Solution (ORS) in preventing burn shock. A recent feasibility and pilot study(n=30) of this Enteral-based implementation bundle (EResus) i.e., training resources, protocol, and toolkit were conducted. The pilot study allowed for protocol development and testing, established the feasibility, provided key insights into implementation and helped develop infrastructure and study standard operating procedures at the study site. With the current study, the investigators aim to expand the trial to a full effectiveness-implementation trial, which will allow to further hone the EResus protocol and bundle, generate more effective implementation strategies, and obtain a clearer understanding of efficacy and frequency of specific outcomes. This study examines enteral-based resuscitation (i.e. enteral with/without IV Fluids) versus enhanced standard of care IV Fluids for the treatment of major burn injuries. The intervention portion of the study will entail randomization of patients presenting with acute burn injuries of 15-40% total body surface area (TBSA) to an enteral-based resuscitation versus the standard of care IV fluid resuscitation. The intervention will continue through the acute resuscitation period. The primary study variables will include measures of urine output, vital signs, planned and administered resuscitation volumes, and routes of resuscitation along with frequency, timing, and treatment of any gastrointestinal symptomology, and serious adverse events such as kidney injury and aspiration events Further, there will be a qualitative component to the study with focus group discussions of the bedside healthcare providers (doctors and nurses) caring for the enrolled patients, in order to understand the challenges and facilitators of enteral resuscitation. In-depth interviews will be conducted with enrolled patients and their families to further understand the patient perception, experience and challenges and facilitators. Qualitative analysis will be done to understand the major themes of challenges and facilitators to enteral resuscitation.

NCT ID: NCT05555602 Recruiting - Cryotherapy Effect Clinical Trials

Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

To investigate the effect of 10,600 nm CO2 laser combined with Zimmer Cryo 6 forced cold air device on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.

NCT ID: NCT05549232 Recruiting - Burns Clinical Trials

Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital

Start date: August 24, 2022
Phase:
Study type: Observational

The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.