Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients
The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.
NCT02198755 — Chronic Osteomyelitis
Status: Not yet recruiting
http://inclinicaltrials.com/chronic-osteomyelitis/NCT02198755/
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-Osteomyelitis)
The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and treatment of diabetic foot infections state that for the treatment of diabetic foot osteomyelitis "No data support the superiority of any specific antibiotic agent or treatment strategy, route, or duration of therapy." Traditionally, osteomyelitis has been treated with a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high bioavailability and adequate bone penetration have been shown in published studies to be effective for the treatment of osteomyelitis. The investigators propose to conduct a prospective, single-center, randomized, open trial at Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic therapy. Bone/tissue cultures are obtained for all patients for clinical purposes and are sent to pathology for histologic examination and to the clinical microbiology laboratory for culture and susceptibility. Patients will receive six weeks of IV or oral antibiotic therapy depending upon their randomization group. Primary outcomes at six months clinical follow-up will include: (i) no evidence of bone infection and (ii) resolution of ulcer.
NCT02168816 — Osteomyelitis
Status: Terminated
http://inclinicaltrials.com/osteomyelitis/NCT02168816/
Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.
NCT02123628 — Diabetes Mellitus
Status: Completed
http://inclinicaltrials.com/diabetes-mellitus/NCT02123628/
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 — Osteomyelitis
Status: Terminated
http://inclinicaltrials.com/osteomyelitis/NCT02099240/
Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
NCT01764919 — Diabetic Foot Infection
Status: Terminated
http://inclinicaltrials.com/diabetic-foot-infection/NCT01764919/
Diagnostic Tests to Help Determine Osteomyelitis: an Analysis and Comparison of Clinical Signs, Microbiology, Pathology and Radiology.
In this study, the investigators will perform a retrospective chart analysis of patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews, medical records and operative reports via EMR and paper charts will be examined from inpatient records, the Center for Wound Healing, the Emergency Department as well as other institutions involved in the care of the subjects to gather data.
NCT01612962 — Osteomyelitis
Status: Terminated
http://inclinicaltrials.com/osteomyelitis/NCT01612962/
Delayed Primary Versus Late Secondary Wound Closure in the Treatment of Postsurgical Sternum Osteomyelitis
Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1% to 3% with a high mortality rate from 19% to 29% . The most devastating complication of the open sternum is the laceration of the right ventricle which has a very high mortality. Additionally destabilizations of the thoracic cage, prolonged immobilization, or substantial surgical trauma are further complications of the conventional strategy (4). In addition, postoperative infections after sternotomy are associated with prolonged hospital stay, increased healthcare costs and impaired quality of patient life, representing an economic and social burden. The emergence of increasing antimicrobial resistant bacteria augments the importance of postsurgical infections since the antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an indicator for the quality of patient care in the international benchmark studies. Although several therapy strategies are nowadays present in clinical practice, there is a lack of evidence based surgical consensus for treatment of this surgical complication. In most case the poststernotomy mediastinitis is involving surgical revision with debridement, open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest wound was achieved secondary closure and/or reconstruction with vascularized soft tissue flaps such as omentum or pectoral muscle is performed. It seems there is a need for more effective surgical treatment of poststernotomy wound infections, which may address the prolonged hospitalization and reduce number of surgical interventions and with this also perioperative morbidity. In light of this we propose a randomized study comparing new delay primary closure of the sternum to the secondary vacuum assisted closure.
NCT01473979 — Mediastinitis
Status: Not yet recruiting
http://inclinicaltrials.com/mediastinitis/NCT01473979/
Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.
NCT01336803 — Osteosarcoma
Status: Completed
http://inclinicaltrials.com/osteosarcoma/NCT01336803/
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .
NCT01137903 — Diabetic Foot
Status: Recruiting
http://inclinicaltrials.com/diabetic-foot/NCT01137903/
Clinical Features, Microbiological-, Radiological Characteristics, and Differential Diagnosis of Vertebral Osteomyelitis
Vertebral osteomyelitis is a uncommon disease that can lead to neurologic deficits if not diagnosed in time. The etiologies of vertebral osteomyelitis include pyogenic bacteria, M. tuberculosis, Brucella species, and fungus. The aim of this study is to describe the clinical features and microbiological/radiological characteristics of patients with vertebral osteomyelitis, and investigate the useful tips for the differential diagnosis of vertebral osteomyelitis.
NCT01125839 — Vertebral Osteomyelitis
Status: Completed
http://inclinicaltrials.com/vertebral-osteomyelitis/NCT01125839/