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A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hype1
Pediatric
Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a
pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). expand
The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Type: Interventional Start Date: May 2024 |
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With P1
Prader-Willi Syndrome
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability
of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS. expand
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS. Type: Interventional Start Date: Jan 2024 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve1
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, ster1 expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: May 2021 |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Current1
Solid Tumors
Hematologic Malignancies
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-1 expand
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Type: Interventional Start Date: Aug 2018 |
Augmented Pacing for Shock in the Cardiac Intensive Care Unit
Cardiogenic Shock
Bradycardia
Shock
The goal of this clinical trial is to learn if backup pacing at an increased rate
improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and
cardiogenic shock. The main question it aims to answer is:
Does increasing the backup pacing rate to 100 beats per minute lead to1 expand
The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is: Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate. Type: Interventional Start Date: Apr 2025 |
A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
In this study, the researchers will look at whether having participants switch from
durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an
effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC).
The researchers will see whether this s1 expand
In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib). Type: Interventional Start Date: Mar 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or
1305-0023).
The goal of this study is t1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or 1305-0023). The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: Sep 2024 |
Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (C1
Heart Failure
Heart Failure Preserved Ejection Fraction
Cardiovascular Diseases
Heart Diseases
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine
compared to placebo to lower NT-proBNP in patients with chronic heart failure with
preserved ejection fraction expand
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction Type: Interventional Start Date: Feb 2024 |
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects Wit1
Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
Juvenile Dermatomyositis
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory
Myopathy expand
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy Type: Interventional Start Date: Dec 2023 |
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overw1
Obesity
Overweight
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in
adolescents that have obesity or overweight with at least one weight-related comorbidity.
The study will last approximately 90 weeks and may include up to 25 visits. expand
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Type: Interventional Start Date: Oct 2023 |
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in O1
Diabetes Mellitus
Hypertension
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing
written visit information via the patient portal (NOTES) versus NOTES plus visit audio
recording (AUDIO) to older adult patients with chronic diseases on quality of life and
other outcomes. During the trial, the te1 expand
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project. Type: Interventional Start Date: Jan 2024 |
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
Post-Bariatric Hypoglycemia
The Total duration of trial participation for each participant with post-bariatric
hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
- 19 weeks for the Core Phase. It is composed of:
- a Screening period: a maximum of 3 weeks
- a Run-in p1 expand
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment). Type: Interventional Start Date: Jan 2024 |
Combined Electric and Acoustic Hearing (EAS) in Children and Adults
Cochlear Implant
Hearing Loss
Cochlear implants are surgically implanted devices which restore the ability to hear to
the hearing impaired. Improvements in surgery and electrodes have results in an increased
number of adults and children who have residual hearing and can benefit from electric and
acoustic hearing in the same ea1 expand
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear. Type: Interventional Start Date: Dec 2022 |
Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers
Autism
Autism Spectrum Disorder
The primary goal of this study is to examine rhythm sensitivity as a predictor of
response to naturalistic developmental behavioral intervention (NDBIs) in autistic
toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based
NDBI that supports children's imitation and s1 expand
The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected. Type: Interventional Start Date: Jul 2023 |
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Surgery
Postoperative Blood Loss
This study will be a prospective randomized study to evaluate the effect of tranexamic
acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing
rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra-
and post-operative bleeding and postope1 expand
This study will be a prospective randomized study to evaluate the effect of tranexamic acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra- and post-operative bleeding and postoperative bruising and swelling. Type: Interventional Start Date: Apr 2023 |
3D Specimen Maps for RT Planning
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Radiation Therapy
The primary objective of this study is to measure the impact of patient-specific 3D
specimen maps on adjuvant radiation treatment volumes and doses to critical organs. All
patients will receive standard-of-care post-operative radiotherapy not impacted by the
experimental 3D specimen maps. The secon1 expand
The primary objective of this study is to measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment volumes and doses to critical organs. All patients will receive standard-of-care post-operative radiotherapy not impacted by the experimental 3D specimen maps. The secondary objective is to demonstrate the feasibility of incorporating 3D specimen mapping tools into post-operative communication, and to determine if utilization of the 3D specimen map improves post-operative communication between surgeons, pathologists, and radiation oncologists. Type: Observational Start Date: Jan 2023 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Focal Onset Seizures
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study that will evaluate the clinical efficacy, safety and tolerability of XEN1101
administered as adjunctive therapy in focal-onset seizures. expand
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures. Type: Interventional Start Date: May 2023 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic1
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Breast Neoplasms
Invasive Breast Cancer
Estrogen-receptor-positive Breast Cancer
HER2-negative Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for
pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of
drugs called selective estrogen receptor modulators or "SERM", which help block estrogen
from attaching to cancer cells. This s1 expand
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part. The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it. The treatment part has two parts: - Part 2a will enroll 162 participants whose tumors have a high level of cell proliferation as indicated by the presence of a biomarker called Ki-67 (greater than 10%). Participants will be randomly assigned to one of two groups (50/50 chance): 1. a group receiving (Z)-endoxifen daily with a monthly injection of goserelin 2. a group receiving the current standard treatment of exemestane (an aromatase inhibitor that lowers estrogen) with a monthly injection of goserelin. - The Part 2b will enroll about 30 participants whose tumors have low Ki-67 levels (10% or less). These participants will take daily (Z)-endoxifen alone without goserelin. A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery. Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit. Type: Interventional Start Date: Feb 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Proteas1
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) develo1 expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Sub1
Migraine
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo
as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years
with episodic migraine. expand
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine. Type: Interventional Start Date: Feb 2022 |
The CONFORM Pivotal Trial
Atrial Fibrillation
Stroke
The CLAAS® device will be evaluated for safety and efficacy by establishing its
performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left
atrial appendage closure devices in patients with non-valvular atrial fibrillation.
Patients who are eligible for the trial will be ra1 expand
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant. Type: Interventional Start Date: May 2022 |
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment f1
Advanced Extrapulmonary Neuroendocrine Carcinoma
Metastatic Extrapulmonary Neuroendocrine Carcinoma
Recurrent Extrapulmonary Neuroendocrine Carcinoma
Unresectable Extrapulmonary Neuroendocrine Carcinoma
This phase II/III trial compares the effect of immunotherapy with atezolizumab in
combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin)
and etoposide versus standard therapy alone for the treatment of poorly differentiated
extrapulmonary (originated outside the lung1 expand
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone. Type: Interventional Start Date: Jun 2022 |
Tobramycin Injection to Prevent Infection in Open Fractures
Wound Infection
Fractures, Open
Surgical Site Infection
The goal of open extremity fracture (OEF) treatment is to promote fracture healing and
restore function while preventing the development of infection. This is achieved through
systematic and timely wound debridement and irrigation, fracture stabilization, tetanus
prophylaxis, systemic and local ant1 expand
The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance. Type: Interventional Start Date: Jan 2022 |
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