Clinical Research Directory

Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin

The goal of this clinical trial is to determine whether preoperative antibiotic prophylaxis with cefazolin is necessary to prevent surgical site infections in adult women undergoing breast-conserving surgery (lumpectomy or partial mastectomy) for breast cancer. Specifically, the trial aims to establish whether surgery without antibiotic prophylaxis is non-inferior to surgery with cefazolin prophylaxis in terms of surgical site infections within 30 days after surgery. The main questions it aims to answer are: * Is the rate of surgical site infections within 30 days after surgery without antibiotic prophylaxis non-inferior to that observed with cefazolin prophylaxis? * How does surgery without antibiotic prophylaxis affect postoperative complications, including antibiotic-related adverse events, and the subsequent management of surgical site infections? Researchers will compare preoperative cefazolin prophylaxis (2 g administered intravenously) with placebo (0.9% saline solution) to determine whether surgery without antibiotic prophylaxis is non-inferior to surgery with cefazolin prophylaxis in preventing surgical site infections. A total of 1,600 participants will be randomly assigned to one of the two groups. Neither the participants nor the healthcare professionals involved in their care will know which treatment has been administered. Participants will: * Undergo breast-conserving surgery for breast cancer, with or without a sentinel lymph node procedure, as part of their usual care. * Receive a single intravenous administration of either cefazolin or placebo before the surgical incision. * Receive information about the signs and symptoms of surgical site infections and how to contact the study team if an infection is suspected. * Be contacted by telephone approximately 15 and 30 days after surgery to assess the occurrence of surgical site infections and other postoperative complications. No additional hospital visits are required specifically for the study.

Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students

This study aims to evaluate the effectiveness of digital game-based learning in teaching evidence-based surgical site infection prevention interventions to second-year nursing students. Using a mixed-methods randomized controlled design, students will be assigned to either a digital game-based learning group or a traditional theoretical education group. Quantitative outcomes will assess changes in students' knowledge levels and cognitive load across three measurement points (baseline, 4-week post-intervention, and 8-week follow-up). In addition, qualitative data will be collected through semi-structured interviews with students in the intervention group to explore their learning experiences and perceptions of the digital learning approach. The findings of this study are expected to contribute to evidence-based educational strategies in nursing education, particularly in the teaching of surgical site infection prevention.

Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study

Spinal surgery carries a risk of surgical wound infections (i.e., the entry of bacteria). Despite various preventive measures, such infections continue to occur, particularly in operations involving implants. In this study, we would like to investigate whether rinsing the surgical wound with a special irrigation solution called PREVENTIA® can reduce the number of bacteria in the wound during the operation.

Effect of Topical Diltiazem Plus Fusidic Acid Versus Fusidic Acid Alone on Episiotomy Healing, Pain, and Resumption of Sexual Activity: A Randomized Controlled Trial in Azadi Teaching Hospital

The goal of this clinical trial is to learn if diltiazem gel combined with fucidic acid cream works better than fucidic acid cream alone to prevent surgical site infection following episiotomy repair. It will also learn about the safety of this regimen. The main questions it aims to answer are: Does diltiazem gel combined with fucidic acid cream lower the incidence of surgical site infection? What medical problems do participants have when taking this regimen? Researchers will compare whether diltiazem gel combined with fucidic acid cream versus the fucidic acid cream alone to see if the first protocol works better? Participants will: Apply diltiazem gel combined with fucidic acid cream twice/day for 10 days Visit the clinic on days 3, 7, and 10 for checkups and tests Keep a diary of their symptoms and the number of times they use the regimen.

Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy

Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. However, the relevance of this strategy may depend on local microbiological ecology. This monocentric ambispective cohort study aims to compare SSI rates between two periods: before and after implementation of piperacillin/tazobactam prophylaxis. The study also evaluates microbiological profiles of bile cultures, antibiotic susceptibility, and postoperative antibiotic exposure. The primary hypothesis is that adaptation of antibiotic prophylaxis to local ecology may optimize outcomes while limiting unnecessary exposure to broad-spectrum antibiotics.