Clinical Research Directory

Simulation-Based Subcutaneous Injection Training in Midwifery Students

The goal of this clinical trial is to compare three simulation-based approaches for teaching subcutaneous injections to first-year midwifery students. A subcutaneous injection is an injection given into the tissue just under the skin. The main questions this study aims to answer are: Do the three teaching approaches lead to different levels of learning and injection skills? Do the approaches affect students' confidence in performing the skill? Do the approaches affect students' anxiety during injection practice? Researchers will compare three groups of midwifery students. One group will practice on the abdominal area of a patient-care mannequin. A second group will practice on an injection training pad placed on a peer's abdomen. A third group will practice on an injection training pad placed on their own abdomen. Participants will first receive the same classroom teaching and laboratory instruction on subcutaneous injection. One week later, they will practice the injection according to the group to which they were randomly assigned. No medication will be injected into a participant's body; the practice will use training equipment and saline solution. After the practice, researchers will assess participants' learning, injection skills, self-efficacy, and anxiety.

First-in-Human Safety Study for Fractomer™ Biomatrix

The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers. The main question it aims to answer is: How do healthy volunteers react to this injectable implant? Participants will receive a subcutaneous injection of Fractomer and their health will be monitored. After the monitoring period, the implant will be removed.

Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Background: Multidrug-resistant bacteria are a major public health problem worldwide, notably due to excess mortality and an increase in the length of hospital stay. Antibiotics that can be used to treat these infections are limited. Daptomycin is one of the most widely used antibiotics for the treatment of infections with gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is therefore interesting to find new routes of administration in order to widen the possibilities of using daptomycin, especially in people who have difficulties with the venous approach. Methods/design: In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous and the intravenous route of daptomycin in healthy volunteers. They will conclude the bioequivalence if the confidence interval of the area under the curve obtained is entirely within the interval \[80% - 125%\]. Discussion: This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a clinical trial in infected patients in order to assess the efficacy and safety of daptomycin by the subcutaneous route.