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Burns clinical trials

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NCT ID: NCT04313907 Recruiting - Clinical trials for Burning Mouth Syndrome

Low Level Laser Therapy Plus Topical Clonazepam Treatment to Burning Mouth Symdrome

BurnLasCLo
Start date: August 16, 2019
Phase: Phase 4
Study type: Interventional

Burning mouth syndrome (BMS) is a condition that affects the oral mucosa; this is seen mainly in postmenopausal women. The intensity of burning and its clinical manifestations may be variable between patients. The etiology of the BMS is unknown, just as it is the therapeutic; hence the latter has not been fully accepted. Therefore, the use of low-level laser therapy (LLLT) and topical clonazepam have been proposed as treatment alternatives. The objective is to assess the effectiveness of the combination of LLLT and topical clonazepam for the reduction of burning symptoms. Three groups will be randomly formed: 1) the first group will received topical clonazepam therapy (half of a 2 mg tablet), patients in this group will be asked to applied it in a mouthwash type for 3 minutes and then spit it out; to the same group, six sessions of LLLT (Biolase 10 ©) will be applied in every second day intervals; 2) the second group, will received the same treatment with clonazepam and laser therapies with similar characteristics to the study group, but the laser will be deactivated; 3) the third group, will receive six sessions of LLLT (Biolase 10 ©) in every second day intervals and placebo tablets with similar characteristics to those of clonazepam. For all groups, both treatments will be received for two weeks. For the assessment of oral burning the visual analog scale (VAS) and the Oral Health Impact Profile-14 (OHIP-14) will be used; with these tools we will measure how oral disorders affect daily life. The measurement scales will be applied at the initial assessment and at day 14th, one month, two months and three months post treatment. The means obtained to assess the effectiveness of the treatment will be compared.

NCT ID: NCT04292054 Recruiting - Burns Surgery Clinical Trials

Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)

A2B
Start date: October 11, 2020
Phase: Phase 3
Study type: Interventional

The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis). Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis. The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.

NCT ID: NCT04264065 Recruiting - Severe Burn Clinical Trials

Albumin and Prognosis of Severely Patients Burns

ALBUBURN
Start date: September 16, 2022
Phase:
Study type: Observational

Hemodynamic management has long been identified as a key factor affecting burn prognosis. However, large amounts of crystalloid infusion have been associated with the development or aggravation of organ failure (acute respiratory distress syndrome, vascular injury, acute renal failure, and intra-abdominal hypertension) which worsens the final prognosis. The use of albumin during the first 24 hours of burn resuscitation is controversial since capillary leakage may cause transcapillary passage of large molecules into the interstitial space. In fact, human albumin has multiple physiological effects, including regulation of colloidal osmotic pressure, antioxidant properties, nitric oxide modulation and buffering capacities, plasma binding and transport of various substances, which may be particularly important in severe burns. Currently available data suggest that administration of exogenous albumin during the first 24 hours of resuscitation of severe burn patients may be associated with improved outcomes. Multi-centre randomized controlled trials with adequate power should be undertaken in burned patients.

NCT ID: NCT04235296 Recruiting - Clinical trials for Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound

Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Start date: November 17, 2019
Phase: Phase 1
Study type: Interventional

Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.

NCT ID: NCT04152096 Recruiting - Burns Clinical Trials

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Burns

Start date: January 24, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of burns. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

NCT ID: NCT04090424 Recruiting - Burns Clinical Trials

Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

Start date: September 21, 2021
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT03997942 Recruiting - Burn; Arm Clinical Trials

The Effect of Proprioceptive Neuromuscular Facilitation and Mirror Therapy on Range of Motion, Pain, Functionality, Kinesophobia and Quality of Life in Patients With Upper Extremity Burns

Start date: May 1, 2019
Phase:
Study type: Observational [Patient Registry]

Purpose of the study; The aim of this study was to investigate the effect of two different exercise programs on joint patency, pain, functionality, kinesophobia and quality of life in upper extremity burn patients. Lütfi Kırdar Training and Research Hospital Burn and Wound Center and unilateral upper extremity burns will consist of individuals aged 18-65 years. 48 burn patients who volunteered to participate in the study will be included in the study. Demographic information of the cases will be recorded. Joint range of motion and pain will be evaluated with the Visual Analogue Scale (VAS) before and after the treatment program. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to evaluate upper extremity functions. TAMPA Kinezophobia questionnaire will also be used for kinesiophobia. To evaluate the quality of life, Burn-Specific Health Scale developed for burn patients will be used.

NCT ID: NCT03992547 Recruiting - Burns Clinical Trials

The Effects of Robot-assisted Gait Training(RAGT) On Patients With Burn

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate RAGT effects, we compare the results of RGAT group to the results of matched conventional(CON) rehabilitation group.

NCT ID: NCT03948360 Recruiting - Burn Wound Clinical Trials

Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

Start date: September 7, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03941535 Recruiting - Burns Clinical Trials

Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

VITK
Start date: May 10, 2019
Phase: Phase 4
Study type: Interventional

The use of Vitamin K in treating bleeding diatheses is well documented and accepted as standard of care, as is the effect of Vitamin K on calcium and bone metabolism. In the treatment of larger burns however, there is a paucity of available literature related to optimal daily dosing, goals of therapy and potential complications. This study aims to identify any potential issues arising from the administration of a standard of care dose in an historical cohort of subjects with larger burns to a prospective patient population given a decreasing dose during their intensive care unit (ICU) stay.