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NCT ID: NCT01418456 Not yet recruiting - Diabetes Clinical Trials

Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics

KADFUT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form. - All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group. - The antibiotic group will receive standard treatment along with antibiotics. - The control group will have standard treatment alone. - Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks. - Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes

NCT ID: NCT01417780 Completed - Clinical trials for Necrotizing Soft Tissue Infections

Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients

Start date: December 2011
Phase: Phase 2
Study type: Interventional

A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

NCT ID: NCT01414959 Completed - Pneumonia Clinical Trials

Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients

Start date: August 2011
Phase: N/A
Study type: Observational

The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.

NCT ID: NCT01413659 Not yet recruiting - Clinical trials for Postoperative Wound Infection

Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery

Start date: September 2011
Phase: Phase 0
Study type: Interventional

The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.

NCT ID: NCT01412801 Completed - Clinical trials for Bacterial Infections

Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.

NCT ID: NCT01411891 Completed - Catheter Infections Clinical Trials

Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per 10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030. Effective post-operative analgesia is an important component with regards to patient satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of thromboembolic disease in patients undergoing total knee or total hip replacement when compared with general anesthesia. Post-operatively, regional anesthesia has been shown to reduce pain scores and/or morphine consumption as well as opioid-related adverse effects. Epidural catheter or spinal anesthesia has become the standard of care at the University of Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still occasionally used for patients that would strongly prefer a general anesthetic, those that are taking anticoagulation medications or with a coagulopathy, those with previous back surgery, and those with certain neurologic conditions such as multiple sclerosis or spina bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters (FNC) for postoperative analgesia following TKA show no significant difference in pain scores, morphine consumption, or post-operative nausea and vomiting. However, epidural analgesia has been associated with higher incidence of hypotension and urinary retention. FNC's placed for postoperative pain allow patients to ambulate more effectively as there should not be much of a lower extremity motor block. Patients with a FNC for postoperative analgesia also do not require a urinary catheter which eliminates a common source of infection in postoperative patients. FNCs have also demonstrated improved rehabilitation times and decreased hospital stays which has led to an increased insertion rate of FNCs for postoperative analgesia following TKA at the University of Wisconsin. Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and 5.6% following revision TKA. Infection can be a devastating complication following implantation of joint hardware often leading to extended hospitalization/rehabilitation stays and return trips to the operating room. The average billed charges for all types of revision TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling lines are a known infection risk and indwelling lines in the femoral region are known to be associated with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al. found that 57% of FNCs placed without the use of a chlorhexidine impregnated patch had positive bacterial colonization. They also described three cases of transient bacteremia secondary to FNCs in the 208 catheters that they analyzed. Chlorhexidine impregnated patches also known as "biopatches" have been shown to reduce the incidence of bacterial colonization and infection of various indwelling lines including epidurals and central venous catheters. Currently no standard of care exists that requires the use of biopatches for FNCs. The investigators propose studying the use of the biopatch to reduce the incidence of bacterial colonization of femoral nerve catheters. The investigators will study the efficacy of the biopatch at decreasing the rate of bacterial colonization of FNCs in TKA patients. The FNCs will be inserted in the standard fashion and removed at the end of therapy. Typically the FNC infusion will continue until the morning of post-operation day (POD) #1 or 2. The process for FNC insertion first involves sterile prep and drape of the femoral region. Full sterile technique will be utilized including gown, gloves, and mask. Ultrasound guidance is then commonly utilized to identify the femoral nerve. Following patient sedation and skin infiltration with local anesthetic, a tuohy needle is inserted adjacent to the femoral nerve. A catheter is then threaded through the needle in close proximity to the femoral nerve. Patients will be randomized to either no chlorhexidine impregnated patch or to a chlorhexidine impregnated patch that will be located at the catheter exit site. On the morning of POD 1 or 2, the FNC infusion will be discontinued. Typically, Twenty-four to forty-eight hours after catheter insertion, it will be removed in a sterile fashion and the skin surrounding the catheter exit site will be swabbed and the distal catheter tip will be sent for culture to determine bacterial colonization. In addition, the investigators will interview patients and review clinical data to determine signs of infection and/or catheter tip colonization rates.

NCT ID: NCT01409525 Not yet recruiting - Clinical trials for Coronary Artery Bypass Surgery Patients

Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.

NCT ID: NCT01407016 Completed - Infection Clinical Trials

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.

NCT ID: NCT01406587 Completed - Clinical trials for Urinary Tract Infection

Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

Start date: July 2011
Phase: Phase 2
Study type: Interventional

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

NCT ID: NCT01402778 Completed - Infection Clinical Trials

Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

TDPAFD
Start date: January 2011
Phase: N/A
Study type: Observational

Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.