Clinical Research Directory

APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows: 1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use); 2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits; 3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.

Utilizing RENASYS◊ DYNAFLOW Instillation Therapy System for Wound Management in Adults With Acute and Chronic Wounds

The purpose of this study is to investigate the functional performance of the RENASYS◊ DYNAFLOW Instillation Therapy System for wound management in adults with acute and chronic wounds. The main question is for clinicians to assess whether this device is completely unsuitable, neutral, or completely suitable for wound management using negative pressure wound therapy with instillation. Participants will have up to 3 dressings applied over their wound with saline administered via negative pressure for up to 9 days and participate in ongoing checkups by the study team.

Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation

This study compares the effects of two primary airway humidification methods-active heated humidifiers (HHs) and passive heat-and-moisture exchangers (HMEs)-on trauma intensive care unit (ICU) patients requiring prolonged mechanical ventilation. Adequate humidification is essential during mechanical ventilation because artificial airways bypass the body's natural ability to warm and moisten inhaled air. While existing guidelines show no overall superiority of one method over the other in general ICU populations, trauma patients present unique challenges, such as thick or bloody secretions, which may lead to airway obstructions and affect the performance of these devices. The main purpose of this randomized controlled trial is to evaluate how active versus passive humidification impacts airway complications (such as secretion viscosity and tube obstruction) and clinical outcomes (including ventilator-associated pneumonia, duration of mechanical ventilation, length of ICU stay, and mortality rates). A total of 162 adult trauma patients at Assiut University Hospital will be randomly assigned to either the HH group or the HME group to determine if there are significant clinical differences between the two methods in this specific patient population.

Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest

This retrospective population-based cohort study uses linked administrative healthcare data from the Local Health Authority of Bologna (Italy) to describe the use of four classes of psychoactive drugs (opioids, antiepileptics, antipsychotics, and antidepressants) after hospital discharge in two populations, adults admitted urgently for trauma and adults surviving out-of-hospital cardiac arrest, and to evaluate whether post-discharge exposure is associated with low-acuity or incomplete emergency department visits and urgent hospital readmissions within one year. Exposure is derived from outpatient dispensing records and classified as naive (started after discharge), long-term (before and after), or interrupted, and as current or not current over follow-up. Associations are estimated with marginal count regression models adjusted for demographics, illness or injury severity, and comorbidity, separately for each cohort.

Prehospital Management of Hypotensive Trauma in HEMS

Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality. Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes. Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies. With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome

Predictors of In-Hospital Mortality in Severe Abdominal Trauma

Severe abdominal trauma is a leading cause of early death from bleeding and of later death from sepsis and organ failure. Clinicians use scoring systems to estimate the risk of dying, but most of these scores were developed and calibrated in high-income trauma systems and may perform differently in high-volume referral hospitals elsewhere, where patients frequently arrive after a prehospital delay and already in established shock. This study will prospectively follow consecutive patients aged 16 years and older admitted to a single tertiary trauma centre with severe abdominal injury over a 12-month period. Severe abdominal trauma is defined as an Abbreviated Injury Scale score of 3 or more for the abdominal region, and/or an abdominal injury requiring emergency laparotomy, laparoscopy or angioembolisation, and/or admission to intensive care for management of an abdominal injury. A total of 430 evaluable patients is anticipated. Information generated as part of routine trauma care will be recorded prospectively from arrival until hospital discharge: age, sex and comorbidity; injury mechanism, time from injury to arrival and mode of arrival; arrival physiology (systolic blood pressure, heart rate, shock index, Glasgow Coma Scale, respiratory rate, oxygen saturation, temperature); admission biochemistry (arterial lactate, base deficit, pH, haemoglobin, platelet count, INR); imaging and operative findings with American Association for the Surgery of Trauma organ injury grades; transfusion and operative management; and in-hospital complications. The primary outcome is in-hospital all-cause mortality. Survivors and non-survivors will be compared, and a multivariable logistic regression model will be built to identify admission and early in-hospital variables that independently predict death. Model discrimination and calibration will be assessed and internally validated by bootstrap resampling, and performance will be compared with that of the Injury Severity Score, Revised Trauma Score, TRISS and the MGAP score. If the model is robust, a simplified integer bedside risk score will be derived and internally validated. The study is purely observational: it mandates no additional investigations, interventions or visits, and all clinical decisions remain with the attending trauma team according to institutional ATLS-based protocols. The findings are intended to support locally valid triage, transfusion and damage-control decision-making and to enable fair outcome benchmarking between comparable centres.

Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia

The goal of this retrospective observational study is to learn how well three simple trauma scores predict death during the hospital stay in adults admitted to intensive care after an injury in Tunisia. The scores are the Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS). Researchers will review existing medical records for admissions from 1 January 2018 through 31 December 2025. They will not assign treatment or contact participants. The main question is how accurately the three scores distinguish participants who died in the hospital from those discharged alive. Secondary analyses will examine agreement between score-based risk and observed mortality and performance for mortality by day 7 after ICU admission.

Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home

Pressure ulcers remain a significant healthcare burden in community and home care settings, particularly among immobile patients. Effective prevention strategies require caregiver education and implementation of evidence-based care bundles. The SSKIN care bundle (Surface, Skin inspection, Keep moving, Incontinence management, Nutrition) is an internationally recognized approach, but its effectiveness when implemented by informal home caregivers using culturally adapted materials remains unclear. This study aimed to compare the knowledge and competency of informal caregivers who received structured training on the SSKIN care bundle versus those receiving traditional verbal instructions, and to evaluate the impact of this training on the incidence of pressure ulcer development in community-dwelling patients at risk for pressure ulcers. Eligible patients were ≥18 years old, at risk for pressure ulcers due to limited mobility (bed-bound or requiring mechanical assistance for repositioning), able to provide informed consent, and receiving home health care services. Eligible caregivers were informal or hired caregivers responsible for daily patient care. Primary outcomes included the caregivers' knowledge of pressure ulcer prevention, assessed via pre-test and post-test questionnaires and the incidence of new pressure ulcers developed during the 6-month follow-up period. Secondary outcome was the mortality rate during the study period.

NG004 in Spinal Cord Injury Patients

This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).

Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.

Machine Learning for Handheld Vascular Studies

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

A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

Blood Flow Restriction Training After Patellar INStability

This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.

Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.

Pilot Trial for WounDx™ Clinical Decision Support Tool

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.

Human Penile Allotransplantation

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.

Feasibility Study for Fibroblast Autologous Skin Grafts

This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.

Effects of Environmental Heat Exposure on Human Multiple Organ Function

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.

Human Upper Extremity Allotransplantation

Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedback. However, hand and arm transplantation is a means to restore the appearance, anatomy, and function of a native hand. Although over 70 hand transplants have been performed to date and good functional results have been achieved, widespread clinical use has been limited due to adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of hand transplantation. Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand transplantation as a safe and effective reconstructive treatment for upper extremity amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 30 human hand transplants employing this novel protocol. Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term high dose multi-drug immunosuppression. Significance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into family and social life as "whole" individuals. The protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this life-enhancing procedure and enabling widespread clinical application of hand transplantation.

Effect of Giving Reduced Fluid in Children After Trauma

This study is designed to help decide how much intravenous (IV) fluid should be given to pediatric trauma patients. No standard currently exists for managing fluids in critically ill pediatric trauma patients, and many fluid strategies are now in practice. For decades, trauma patients got high volumes of IV fluid. Recent studies in adults show that patients actually do better by giving less fluid. The investigators do not know if this is true in children and this study is designed to answer that question and provide guidelines for IV fluid management in children after trauma.

Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care

The aim of this study is to eliminate the malodorous of chronic wound and increase the chance of the healing of recalcitrant wounds by using the repairing gel (supraz gel) which has the approved components in wound healing and platelet-rich plasma-fibrin glue.

Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness

This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

Food is Medicine Prospective Study

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.

Clinical Registry Collecting Real World Evidence on Wound Care Treatments

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.