61 Clinical Trials for Various Conditions
The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and acute general surgery patients. The technique involves source control of sepsis and hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut short to allow for resuscitation in the ICU after the immediately life threatening pathology is treated. Planned re-exploration is then performed within 24-48 hours. It is at this procedure that the injuries are reconstructed. This technique, unfortunately, has several complications implicit with its use including wound infection, enterocutaneous fistula formation, and intra-abdominal abscess development.\[1\] Additionally, in patients whom primary fascial closure is not achieved, extensive abdominal wall reconstruction will be required in 6-12 months. The key for preventing these complications is definitive closure of the abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an open abdominal wound at dismissal \[1,2\] Proven methods for decreasing the rate of planned ventral hernia utilize tension in the midline to counter the effects of lateral abdominal muscular retraction.\[3,4,5\] Despite these improvements, however, the planned ventral hernia rate continues to be substantial.\[2\] Botulinum toxin a (BTX) is an FDA approved neuron modulating agent which has been used extensively in cosmetic, motor and pain disorders over the past 20 years \[6,7\]. The toxin blocks acetylcholine and pain modulator release (calcitonin gene related peptide and substance P) from the pre-synaptic cholinergic nerve terminal. The peptides are unable to bind at their motor end plate receptors through a process that cleaves proteins involved in the transport protein cascade. This results in flaccid paralysis and neuromodulation of the abdominal wall muscles resulting in reduced lateral tension and pain. Theoretically, this could increase the rates of primary fascial closure, improve pain sensation, decrease the rate of complications associated with open abdomens all while lowering the costs and need for future abdominal wall reconstruction.
This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. The study addresses the common complications of incisional surgical site infections (SSI) and fascial dehiscence (FD) following emergency exploratory laparotomy. The primary objective is to assess the effectiveness of triclosan-coated barbed suture and conventional non-barbed suture in reducing the rates of incisional SSI and FD within 30 days postoperatively. The study population comprises adult patients undergoing emergent laparotomy for traumatic injuries or acute intraabdominal pathology. This prospective, single-blinded randomized control trial will be conducted at Los Angeles General Medical Center. Patients will be randomized to receive either triclosan-coated barbed suture or conventional non-barbed suture for abdominal fascial closure, with a standard closure technique employed. Patients will be followed up for 30 days postoperatively to monitor surgical site infections, fascial dehiscence, and other outcomes. Statistical analysis will be conducted to compare outcomes between the study arms, assessing the efficacy of triclosan-coated barbed suture in reducing the incidence of SSI and FD, along with secondary outcomes.
It is a retrospective study. Patients, who presented with either traumatic or general surgery emergencies, undergone exploratory laparotomy, had an open abdomen management and received Direct Peritoneal Resuscitation in addition to standard resuscitation will be considered as meeting the criteria to collect the data.
The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to analyze surgical site infection rates between wound closure with and without Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality Improvement Program data from previous standard of care (primary closure after colorectal surgery) will be used for comparison with newly adopted standard of care treatment regimen (wound closure with NPWT). Data on patients who underwent intra-abdominal surgery will be retrospectively collected and a database will be created. These individuals will be identified through medical records and recontacted by mail and/or phone to collect study data. Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery will be enrolled in the database. After giving informed consent, data on surgical site infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30 days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to a group of patients treated by the Principal Investigator who also underwent intra-abdominal surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated with negative pressure wound therapy following intra-abdominal surgery will develop surgical site infections than patients who had intra-abdominal surgery but were not treated with Negative Pressure Wound Therapy.
This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.
The submitted proposal is designed to reduce morbidity and mortality to injured children. Significant variability in the initial trauma assessment exists among institutions. The proposed project is a prospective, observational, multi-institutional study of children following blunt abdominal trauma. The specific goals of the project are to: 1) Document history, physical exam findings, imaging, and laboratory values, which are available to physicians during the initial trauma resuscitation prior to a decision on whether to order an abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2) Derive and validate a multi-variable clinical prediction rule based on data variables readily available during the pediatric trauma resuscitation to identify patients at low risk for intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from this study could be used to develop a more standardized approach to the evaluation for intra-abdominal injury following blunt trauma in children. This information could lead to significant improvement in the early recognition of injury and to improved resource utilization.
The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury. Specific aims: Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO. Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO. Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.
Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.
The research protocol aims to compare the utility of contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT scan of abdomen \& pelvis already performed at the referring institution will be identified by the trauma service as eligible for inclusion. The ultrasounds will be performed by one of two Attending Radiologists involved in the study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be monitored for 30 minutes after the contrast agent is given and any adverse reactions will be recorded. Adverse reactions to Optison have occurred within this time frame in the literature. Subsequent medical care will be as indicated per the clinical practice guideline.
The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.
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.
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.
Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.
This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not: 1. rate of abdominal CT scanning 2. time to emergency department disposition 3. the rate of missed/delayed diagnosis of intra-abdominal injury 4. the costs.
Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.
This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.
This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.
Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.
The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma. The questions this study aims to answer are: 1. Does a statistically significant association exist between pancreatic injury grade and the following individual factors: * Mortality * Morbidity * Injury severity score 2. Is there an association between post-operative pancreatic complications and operation-specific intervention? 3. Does pancreatic injury score correlate with certain intra-abdominal organ injuries? Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.
The purpose of this study is to assess wound healing at 24 vs 48 hours post cesarean delivery with a modified 1-day ASEPSIS score.
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.