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Burns clinical trials

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NCT ID: NCT05339490 Not yet recruiting - Burn Injury Clinical Trials

Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)

Bru_PBB
Start date: January 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

Skin, as the outermost organ of the human body, serves as a protective layer from microorganisms and external forces, and allows controlling fluid loss among other important functions (sensory, immune and aesthetic functions). When the skin is burned, the extent of the depth can be classified in 1rst, 2nd superficial to deep, 3rd and 4th degree burns, according to the different layers of the skin and tissue that are affected in depth. Severity of a burn can also be characterized by total body surface area (TBSA), location of the burn injury, subject characteristics and age according to the European Practice Guidelines for Burn Care. The actual gold standard treatment for 3rd or deep 2nd degree burn wounds is skin autografting that means transplantation of healthy skin taken from an undamaged donor site on the patient to the wound site, therefore creating a donor site wound (DSW). The Burn Center of the CHUV has developed Progenitor Biological Bandages (PBB), composed of human skin progenitor cells (produced and stored GMP clinical cell bank with the Hospital accredited Cell Production Center, CPC) seeded on a biodegradable collagen scaffold (Resorba®), to support wound healing of DSW, as well as 2nd degree burn wounds. PBB have been applied at the CHUV under emergency circumstances over the last 20 years in children and adults with a TBSA higher than 10% and 20%, respectively. These PBB aim to increase the spontaneous healing of 2nd superficial and deep burns to avoid the skin autograft, and therefore prevent the creation of a second wound with the DSW. Furthermore, if skin grafting cannot be avoided, in the case of a 3rd or 2nd degree deep burns that do not close spontaneously, the use of PBB is an advantage for treating DSW in order to accelerate its healing process and therefore use the same donor site for future treatments. The aim of this study is to demonstrate the efficacy of the PBB treatment of the DSW compared to standard-care treatment (Jelonet®), and therefore verify our hypothesis of higher performance of PBB. The investigators would like also to assess the efficacy of the DSW treatment on short- and long-term periods, as well as to collect observational data on 2nd degree burn wound treated with PBB. Furthermore, another objective of this study is to confirm the safety of the PBB on DSW and 2nd degree burn wounds.

NCT ID: NCT05324514 Not yet recruiting - Burns Clinical Trials

Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC.

NCT ID: NCT05276843 Not yet recruiting - Burns Clinical Trials

Efficacy of Selected Exercises on Bone Mineral Density in Post-burn Patients

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

PURPOSE: to assess the efficacy of Qigong exercise on bone mineral density in post-burned patient. BACKGROUND: During severe burns, more than 7% of the vertebral bone mineral density (BMD) is lost within 3-6 weeks of the injury and about 3% of the total body bone content is lost during the first 6 months after the injury. Qigong exercise has been shown to be effective at attenuating declines in BMD and improving both balance performance and balance confidence in healthy middle-aged and older adults. There are lack in knowledge and information in published studies about the efficacy of Qigong exercise on bone mineral density in post-burned patient. So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on bone mineral density in post-burned patient. HYPOTHESES: It will be hypothesized that: It was hypothesized that Qigong exercise has no or limited effect in bone mineral density in post-burned patient. RESEARCH QUESTION: Does Qigong exercise an effect on bone mineral density in post-burned patient?

NCT ID: NCT05241912 Not yet recruiting - Burn Surgery Clinical Trials

Supernormal Oxygen Delivery for Patients With Severe Burns

Start date: February 28, 2022
Phase: Early Phase 1
Study type: Interventional

This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.

NCT ID: NCT05223998 Not yet recruiting - Burns Clinical Trials

Sperry Micro-Coring System: Automated Full-Thickness Skin Microcolumns in Dermal Regeneration Templates for 'Donor-Free' Skin Renewal

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) into a dermal regeneration template as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

NCT ID: NCT05126017 Not yet recruiting - Burns Clinical Trials

Examine the Validity of a Panel of Objective Burn Scar Measurement Tools

BOSS-2
Start date: January 2022
Phase:
Study type: Observational

Reliable scar assessment is essential not only when designing clinical trials to investigate the efficacy of new and existing scar therapies, but also in everyday, clinical practice, to examine the progress of our patients' care. Subjective assessments are extremely important; they demonstrate to the patient the changes and improvements in their scars since the primary burn injury. Nevertheless, clinicians require reliable, validated, and objective tools which can yield measurable and reproducible outcomes. These are ultimately needed to achieve the goal of reducing the physical and psychosocial burden of scarring through compelling research. Previously, a pilot study (BOSS-1) was conducted in 55 patients with post burn hypertrophic scars. The investigators measured, among other parameters, scar thickness, density, and pliability, using a panel of objective scar assessment tools, alongside standard subjective measurements (questionnaire-based), and skin biopsy assessments. Measurements were performed at a single time point which varied from 3 months to 6 years post burn injury. This work indicated that measuring scar thickness, pliability and colour together, may provide a global scar objective score. BOSS-2 is a multi-centre study that will validate the preliminary findings in BOSS-1.

NCT ID: NCT05059418 Not yet recruiting - Clinical trials for Burning Mouth Syndrome

Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

BMS
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application. The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.

NCT ID: NCT05004766 Not yet recruiting - Pain Clinical Trials

Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot Training in Burn Patients

Start date: August 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS).

NCT ID: NCT04965883 Not yet recruiting - Burns Clinical Trials

Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.

Start date: July 30, 2021
Phase: N/A
Study type: Interventional

- All the patients will be included in the study will be resuscitated on arrival in our department. - Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth. - Dreesing will be done with topical antimicrobial agent. - Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula. - Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy. - Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ". - The first group will include patients with early surgery from 4 to 10 days since burn. - Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn. - Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment

NCT ID: NCT04884789 Not yet recruiting - Burn Scar Clinical Trials

Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar

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

The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.