Clinical Research Directory

Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy

Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population. This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.

Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:

The study focuses on the serious problem of infections and wound-healing issues that can happen after high-energy bone fractures. These complications are common and can affect between 10% and 60% of patients, especially those with severe injuries. When a fracture is repaired with surgery and an infection develops afterward, patients often face long recovery times, more pain, and sometimes multiple surgeries. In the worst cases, the infection can lead to permanent disability or even amputation. The current standard test used in hospitals, called a culture, often misses certain bacteria, which can make treatment less effective. Because of this, the study aims to find out whether adding a newer test called Next Generation Sequencing (NGS) can help doctors identify infections more accurately and improve patient outcomes. The main goal of the study is to see whether using NGS along with standard hospital cultures reduces the number of treatment failures compared to using standard cultures alone. Treatment failure means the infection does not get better and the patient must return to the operating room. The study also wants to learn whether NGS helps doctors make better antibiotic choices and avoid unnecessary or ineffective treatments. Another goal is to understand which NGS results are most helpful when doctors decide to change a patient's antibiotics. By learning this, researchers hope to create a model that explains how NGS information influences treatment decisions. To join the study, patients must be between 18 and 84 years old and have a deep infection after a fracture was repaired with internal fixation, such as plates, screws, or rods. Patients must also meet infection criteria from either the Fracture-Related Infection (FRI) guidelines or the CDC's infection criteria. A total of 250 patients will be randomly placed into one of two groups: one group will receive treatment guided by both NGS and standard cultures, while the other group will receive treatment based only on standard cultures. Researchers will then compare how often treatment fails in each group. Treatment failure includes several possible outcomes. The most important is an unplanned return to the operating room because the infection did not improve. Other types of failure include new superficial infections that do not require surgery, bones that fail to heal properly (called nonunion), amputation, and complications caused by antibiotics. Patients will return for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after joining the study so researchers can track the patient's progress and monitor for any problems. Right now, the failure rate for treating these infections using standard hospital cultures is about 30%, which is considered unacceptably high. The researchers believe that adding NGS will help lower this number because NGS can detect more types of bacteria, including ones that are hard to grow in a lab. With better information, doctors can choose antibiotics that are more likely to work the first time, which may reduce the need for additional surgeries and improve healing. This could be especially important for military service members, who often suffer high-energy injuries and face a greater risk of long-term complications if treatment fails. NGS is already available, covered by Medicare, and fast enough to be useful in real-time medical decisions. If this study shows that NGS improves treatment outcomes, hospitals could begin using it widely and quickly. The researchers hope that this approach will lead to fewer infections, better antibiotic use, faster recovery, and improved long-term function for patients.

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.

Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During Orthopedic Surgeries in Egyptian Patients.

A randomized controlled trial on adults who underwent orthopedic surgery. To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing SSIs in the orthopedic surgical population. Eligible patients will be randomized in a block design into 2 groups: intervention and control. The intervention group will use continuous infusion of cefazolin (CI), while the control group will follow the traditional presurgical prophylaxis protocol of intermittent cefazolin doses (INT).

Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During CABG Surgeries in Egyptian Patients.

A randomized controlled trial on adults who underwent coronary artery bypass grafting (CABG) surgery. To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing surgical site infection in the CABG population. Eligible patients will be randomized using a block design into 2 groups: intervention and control. The intervention group will use continuous infusion of cefazolin (CI), while the control group will follow the traditional presurgical prophylaxis protocol of intermittent cefazolin doses (INT).

Enhanced Recovery Versus Standard Care After Emergency Abdominal Surgery in Patients Requiring Emergency Laparotomy

This study aims to compare an Enhanced Recovery After Surgery (ERAS) protocol with conventional postoperative care in adults undergoing emergency laparotomy for intestinal obstruction or intestinal perforation. The main question this study aims to answer is: • Does the ERAS protocol reduce surgical site infections compared with conventional care after emergency laparotomy? Researchers will also compare other recovery outcomes between the two groups, including length of hospital stay, occurrence of paralytic ileus (temporary loss of bowel function), time to first bowel movement, and time to start taking fluids by mouth after surgery. A total of 102 participants will be enrolled and randomly assigned to one of two groups. One group will receive postoperative care according to the ERAS protocol, while the other group will receive conventional postoperative care. All participants will undergo emergency laparotomy using standard surgical and anesthetic techniques. Participants will: * Undergo emergency laparotomy for intestinal obstruction or intestinal perforation. * Receive either ERAS-based postoperative care or conventional postoperative care. * Be monitored during their hospital stay for recovery and postoperative complications. * Be assessed for bowel function recovery, ability to tolerate oral fluids, and length of hospital stay. * Be followed for 30 days after surgery to determine whether a surgical site infection develops. The researchers hypothesize that patients managed with the ERAS protocol will have a lower frequency of surgical site infections and improved postoperative recovery compared with those receiving conventional care.

Infection Prevention for "Bellwether" Surgery in Ethiopia

The study examines surgical site infections and antimicrobial resistance following life-saving surgeries like C-sections and leg fracture repairs in Ethiopia. It does not include healthy volunteers because it specifically focuses on patients who require these urgent operations due to medical necessity. Eligible participants are those undergoing these specific procedures at Tikur Anbessa Specialized Hospital or other participating public hospitals. While the birth-related portion is for females, the trauma portion includes both men and women, generally of reproductive or working age with no upper age limit. People are excluded if they are having elective surgeries, cannot provide consent, or cannot be reached for the two-year follow-up period. The researchers use a mixed intervention based on the "Clean Cut" safety bundle, which includes staff training, surgical checklists, and regular audits. The main goals are to measure infection rates within 30 days of surgery and track how well patients can function in their daily lives using the WHODAS scale up to 24 months later.

Prophylactic Use of ciNPWT in Gynecologic Laparotomy

This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing. Participants will: * Get ciNPWT or standard dressing after planned laparotomy * Answer the questionairs about qualite of life * Will visit the clinic 30 days after surgery to see the final result

Effect of Early vs Late Water Exposure After Cutaneous Surgery

This randomized controlled trial aims to compare the effect of early versus delayed water exposure after cutaneous surgeries on the incidence of surgical site infections. Patients undergoing elective cutaneous surgical procedures will be randomly assigned to either early postoperative water exposure within 48 hours or delayed exposure after 7 days. Wound outcomes will be assessed using the Southampton Wound Grading System during follow-up visits. The study seeks to determine whether early water exposure is safe and whether it influences postoperative wound healing and infection rates.

Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal.

This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs. In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges. All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time. The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.

Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail

Long-bone fractures, particularly of femur and tibia, are common following fall injury and road traffic accidents.1,2 The standard treatment is "intramedullary nailing," where a metal rod is inserted into the center of the bone to hold it in place.3,4 However, surgical site infection (SSI) and fracture related infection (FRI) remain significant complications of nailing that delay healing and increase healthcare costs.5,6 To prevent these infections, doctors give patients antibiotics around the time of surgery. However, there is ongoing debate about how long these antibiotics should be continued. In many regions, patients receive antibiotics for several days, but recent evidence suggests that a shorter course may be just as effective and could reduce the risk of antibiotic resistance and side effects. Study Question The goal of this study is to determine if a one-day (short) course of antibiotics is as effective as a three-day (standard) course in preventing infections after bone-nailing surgery. Hypotheses Null Hypothesis (H0): There is no significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols. Alternative Hypothesis (H1): There is a significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols.

Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies

Objectives * Primary: * To measure the reduction in VP shunt infection rates using topical vancomycin powder. * Secondary: * To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory). * To analyze the microbiological profile of failed cases. * To compare the "Time-to-Infection" and shunt survival rates between the study and control groups using Kaplan-Meier analysis. * To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data

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.

Skin Adhesive Plus Intra-cuticular Suture Versus Suture Alone for Cesarean Skin Closure

The goal of this randomized control trial is to compare two skin closure techniques after cesarean section. Both techniques are currently in wide use but no comparison between the two was reasserted yet. The two techniques are- First technique is intracuticular suture using monofilament suture, Second technique is intracuticular suture and biological adhesive material. The investigators' primary outcome is to explore the rate of skin scar complications to understand whether one technique has a lower complication rate then the other. The secondary outcomes is to check whether one technique is better then the other in terms of patients' satisfaction, convenience and scar healing and appearance. Patients at the age of 18 and above, undergoing elective cesarean section at the Hadassa medical center, can participate. participants will be randomly assigned to one of the groups- the firs or the second technique. Patients will be asked to fill out a questionnaire on POD 2 and attend a check-up appointment in-person with their surgeon 6-8 weeks post surgery. at the check-up the patient will be asked to fill out another questionnaire and undergo a scar appearance evaluation by the surgeon.

Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section

To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.

Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery

The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.

A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital

To study and compare the incidence of surgical site infection after cesarean section in pregnant women with subcutaneous wound drainage and those without subcutaneous wound drainage at Queen Savang Vadhana Memorial Hospital, Sriracha. Chonburi Thailand

A Clinical Prediction Model for Surgical Site Infection After Central Nervous System Tumor Surgery

1. Study Background For patients undergoing brain or spinal tumor surgery, postoperative surgical wound infection (known as "surgical site infection," SSI) is a recognized risk. Once an infection occurs, it may complicate and prolong the recovery process. Currently, doctors primarily rely on clinical experience to judge which patients are at higher risk of infection. Our research team has previously developed an intelligent prediction model (a machine learning tool) that can very accurately identify which patients are at higher risk of postoperative infection. This study aims to validate whether implementing enhanced preventive measures for high-risk patients in advance, based on the model's predictions, can effectively reduce the occurrence of infection. 2. Study Purpose The primary purpose of this study is to validate whether an individualized intervention strategy based on an intelligent prediction model can effectively reduce the incidence of surgical site infection in patients after central nervous system tumor surgery. Simultaneously, we will also evaluate the safety of this strategy, its impact on patient hospital stay length and medical costs, as well as its feasibility in practical clinical application. 3. Study Design Type: This is a prospective, single-center clinical validation study. "Prospective" means the research plan is established first, followed by patient recruitment and data collection according to the plan; "single-center" indicates the study is conducted solely at the Chinese Academy of Medical Sciences Cancer Hospital. Process: For all patients who consent to participate in this study, within 72 hours after surgery, the research system will automatically calculate their infection risk based on 8 key clinical indicators (such as blood test results, medical history, etc.). High-Risk Group (model-predicted infection probability ≥50%): Will receive a set of enhanced, individualized infection prevention measures (e.g., adjusted antibiotic regimen, enhanced nutritional support, closer monitoring). Low-Risk Group (model-predicted infection probability \<50%): Will receive the current standard, high-quality postoperative care. Duration: The study is planned to run from February 2026 to October 2029. Each participating patient will be followed for 3 months (90 days) to observe whether infection occurs. Sample Size: It is planned to recruit approximately 500 eligible patients. 4. Primary Evaluation Indicators Primary Indicator: The incidence of surgical site infection within 90 days after surgery. The diagnosis of infection will be made by experts who are unaware of the patient's group assignment, strictly following international standards. Secondary Indicators: Include the accuracy of the intelligent prediction model in practical use, patient hospital stay length, other infection-related complications, medical costs, and the adoption rate of the model's recommendations by physicians. 5. Eligibility Criteria (Inclusion Criteria Summary) You may be eligible to participate in this study if you meet the following conditions: Diagnosed with a brain or spinal tumor and scheduled for elective surgery. Aged 18 years or older. Expected survival exceeds 3 months and able to cooperate with postoperative follow-up. Voluntary participation and signing of a written informed consent form. (Note: This study has detailed exclusion criteria. Final confirmation of whether all criteria are met will be determined by your study doctor.) 6. Patients' Rights and Safety Voluntary Participation: Participation in this study is entirely voluntary. You have the right to withdraw from the study at any time, which will not affect the quality of any normal medical services you are entitled to at our hospital or your relationship with it. Informed Consent: Before the study begins, your study doctor will explain all study procedures, potential risks, and benefits in detail, and you will sign an "Informed Consent Form." Privacy Protection: All your personally identifiable information will be kept strictly confidential. Codes will replace your name and other identifiable information in research analyses and reports. Safety Assurance: This study has been reviewed and approved by the hospital's Ethics Committee. We have established an independent Data Safety Monitoring Board to monitor the study's safety throughout. Clinical trial liability insurance has been purchased for all participants to cover damages related to the trial. 7. Contact Information If you would like to learn more about this study, please contact us via: Principal Investigator: Dr. Yang Ming National Cancer Center/National Clinical Research Center for Cancer/Cancer Research Unit: Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG

This study aims to address the knowledge gap by comparing the outcomes of single-layer and multi-layer leg closure techniques following great saphenous vein harvesting for Coronary artery bypass grafting. Research question: 1. Does single-layer closure compared to multi-layer closure result in better postoperative outcomes in patients undergoing great saphenous vein harvesting for CABG 2. To evaluate the incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques. participants will follow in OPD after 1 week , their wounds will be examined and assessment will be recorded.

Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.