Ongoing Clinical Trials for Post Procedural Infection
There are currently 2 clinical trials investigating ways to prevent infections that can occur after medical procedures. These studies are focused on surgical procedures in different areas: one examines infection prevention after colorectal surgery in France, while the other looks at preventing complications after dental implant surgery in Austria. Both trials test antibiotic strategies to reduce the risk of infection following surgery.
Clinical trial locations
- Austria
- France
Study on Cefoxitin and Sodium Chloride for Preventing Infections After Colorectal Surgery
This trial is investigating the best way to prevent infections after surgery on the colon or rectum. The study is testing an antibiotic called cefoxitin, which helps fight bacteria that can cause infections at the surgical site.
Who can participate: Adults who are 18 years or older and scheduled to undergo colorectal surgery that is expected to last more than 90 minutes. Participants must have access to the Social Security system, be legally free (not under guardianship), and provide informed consent showing they understand the study and agree to take part.
Who cannot participate: Patients not undergoing colorectal surgery, those outside the specified age range, or individuals who are part of vulnerable populations such as children or people with certain disabilities requiring special protection.
What the trial involves: The study compares two different methods of giving cefoxitin. One group receives the antibiotic in regular intermittent doses, while the other receives an initial larger dose followed by a continuous infusion throughout the surgery. This is a double-blind study, meaning neither participants nor researchers know which treatment each person is receiving, ensuring a fair comparison.
Researchers will monitor participants for 30 days after surgery to check for any surgical site infections. They will also track other outcomes including the need for additional surgery, complications such as anastomotic leak (breakdown of the surgical connection between intestines), the length of hospital stay, and any adverse events.
Study medication: The investigational drug is cefoxitin, a second-generation antibiotic that works by stopping bacteria from building their cell walls, which kills them. The study aims to determine whether the continuous infusion method is more effective than standard doses at preventing infections within 30 days after colorectal surgery.
Study on the Effect of Amoxicillin on Post-Surgical Complications in Patients Undergoing Dental Implant Surgery with Bone Regeneration and Sinus Elevation
This trial focuses on patients receiving dental implants in the upper jaw in areas where there is not enough bone. The procedure involves both placing implants and building up bone through a technique called guided bone regeneration, along with lifting the sinus floor to create space for the implant.
Who can participate: Medically healthy adults (classified as ASA I-II, meaning no or mild health issues) who are at least 21 years old. Participants must be non-smokers, former smokers who quit at least 5 years ago, or light smokers (fewer than 10 cigarettes per day). They must have missing teeth in the back upper jaw requiring sinus floor elevation and placement of up to 3 dental implants with guided bone regeneration, specifically when bone height is between 3-5 mm. Participants cannot have allergies to amoxicillin, penicillin, certain pain relievers (NSAIDs), or corn starch, and must not have sinus membrane problems or acute sinusitis requiring ongoing treatment.
Who cannot participate: Patients not undergoing this specific type of dental surgery involving implant placement with bone regeneration and sinus floor elevation, those outside the specified age range, or individuals considered part of vulnerable populations.
What the trial involves: Participants receive either Moxilen 500 mg capsules containing the antibiotic amoxicillin or a placebo (inactive treatment). The study evaluates how these treatments affect recovery, particularly looking at pain, swelling, bleeding, and sinus discomfort.
Participants use visual scales to rate their symptoms daily for the first week, then again at day 14. Clinical evaluations occur at week 2, week 4, between weeks 16-20, and 6 months after the dental crown is installed. During these visits, researchers assess post-surgical complications, implant stability, and any signs of infection or discomfort.
Study medication: The investigational drug is amoxicillin, a penicillin antibiotic taken orally. It works by preventing bacteria from forming cell walls, which destroys them. The study aims to determine whether using antibiotics after this dental surgery reduces complications and improves patient outcomes compared to not using antibiotics.
Summary
Two clinical trials are currently recruiting patients to study infection prevention after different surgical procedures. Each trial takes place in a single European country: one in France focusing on colorectal surgery and one in Austria focusing on dental implant surgery.
Both studies test antibiotic strategies, but they differ in their approaches. The French trial compares different methods of administering the same antibiotic (cefoxitin), while the Austrian trial compares using an antibiotic (amoxicillin) versus not using one. The colorectal surgery trial monitors patients for 30 days post-surgery, while the dental implant trial follows participants for up to 6 months after crown installation.
These studies reflect the ongoing medical effort to find the best ways to prevent infections and complications after surgery, which can improve recovery times and reduce the need for additional medical interventions.
