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Wounds and Injuries clinical trials

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NCT ID: NCT06327113 Not yet recruiting - Non-healing Wound Clinical Trials

Antibiotic Tumescent For Chronic Wounds

TAI
Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic leg wounds will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.

NCT ID: NCT06326827 Not yet recruiting - Orthopedic Disorder Clinical Trials

In'Oss™ (MBCP® Putty) Ortho

Start date: September 2024
Phase:
Study type: Observational

Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery

NCT ID: NCT06324461 Not yet recruiting - Myocardial Injury Clinical Trials

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

GLUMINS
Start date: March 20, 2024
Phase: Phase 4
Study type: Interventional

This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 4 days prior to surgery or receive routine care. Semaglutide (Ozempic; Novo Nordisk, Denmark) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery.

NCT ID: NCT06322186 Not yet recruiting - Hypothermia Clinical Trials

Study to Actively Warm Trauma Patients-2

STAYWARM-2
Start date: March 2024
Phase: N/A
Study type: Interventional

Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function. Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival. This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia.

NCT ID: NCT06321419 Not yet recruiting - Wounds and Injuries Clinical Trials

ATLS vs Standard Care Trial

Start date: October 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06319638 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are: Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients. Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

NCT ID: NCT06316258 Not yet recruiting - Clinical trials for Acquired Brain Injury Including Stroke

Evaluating a CFT Group for Adults With Acquired Brain Injury

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group. The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group. This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting.

NCT ID: NCT06311513 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Start date: April 2024
Phase: Phase 4
Study type: Interventional

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

NCT ID: NCT06305403 Not yet recruiting - Sepsis Clinical Trials

VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury

Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included. To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO. According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not. By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined.

NCT ID: NCT06304324 Not yet recruiting - Foot Diseases Clinical Trials

Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.