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.

Efficacy of Intrawound Vancomycin in Spine Surgery

"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. The study included 416 patients who were allocated using alternating monthly time-clusters (25 months) to receive either standard care with topical vancomycin or standard care alone (control). The primary endpoint, the incidence of 90-day SSI, was evaluated by blinded clinical assessors to minimize bias."

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.

Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus

Staphylococcus aureus are Gram-positive cocci that asymptomatically colonize the skin and mucosal surfaces of approximately 20-30% of healthy individuals . Although they commonly exist as a harmless commensal organisms, S. aureus are one of the most clinically significant opportunistic pathogens, causing a wide range of community and healthcare-associated infections. These infections vary from superficial skin and soft tissue infections to severe invasive diseases, including bacteremia, infective endocarditis, pneumonia, osteomyelitis, and device-associated infections .

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

Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin. The main question it aims to answer is: Does a small drain placed under the skin lower the number of wound complications within 30 days after surgery? Researchers will compare two groups: Participants in one group will have a small closed-suction drain placed under the skin before the skin is closed. Participants in the other group will not have a drain placed under the skin. All participants will have midline abdominal surgery. During surgery, the surgeon will measure the thickness of the tissue under the skin. Participants with a thickness of 2.5 cm or more will be randomly assigned to one of the two groups. In both groups, the tissue under the skin will be closed in a standard way using separate 2/0 Vicryl stitches. Participants in the drain group will have the drain removed when the amount of fluid collected in 24 hours is less than 30 mL, unless the surgeon decides that earlier or later removal is needed. Participants will be followed for 30 days after surgery to check for wound problems such as infection, wound separation, fluid collection, blood collection, or the need for extra wound care or another procedure.

DRONE-WOUND Study: Severe Infection After Drone-Related Combat Trauma

Drone-related combat injuries have become one of the most devastating mechanisms of injury in modern warfare. These injuries often cause extensive tissue devitalization, contamination, open fractures, vascular injuries, and complex soft tissue damage, which may substantially increase the risk of severe wound infection, multidrug-resistant bacterial infection, repeated surgical procedures, limb loss, and sepsis. However, the relationship between the extent of tissue devitalization and the development of severe infection has not been systematically investigated. The DRONE-WOUND Study is a prospective observational cohort study designed to evaluate the association between tissue devitalization and severe wound infection in patients with drone-related combat trauma. The study will collect detailed clinical, surgical, microbiological, and radiological data from injured patients treated at participating trauma centers. Measures of tissue injury, contamination, surgical management, microbiological findings, and infection outcomes will be analyzed to identify factors associated with severe infection and poor clinical outcomes. The findings of this study are expected to improve understanding of the mechanisms leading to infection after drone-related injuries, support early identification of high-risk patients, and inform future strategies for surgical management, antimicrobial therapy, and infection prevention in combat trauma. Ultimately, the study aims to improve limb salvage, reduce infectious complications, and enhance outcomes for patients with severe drone-related injuries.

Closed Incision NPWT to Prevent Wound Complications Post-ECMO

Patients undergoing extracorporeal membrane oxygenation (ECMO) are at increased risk of wound complications at the vascular access site after decannulation. These complications may delay recovery and increase healthcare burden. Closed incision negative pressure wound therapy (NPWT) may improve wound healing by reducing fluid accumulation and supporting the incision. This study evaluates whether prophylactic NPWT reduces wound complications compared to standard wound care following ECMO decannulation.

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.

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

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery. The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery. The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.

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.

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.

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.

The Spotlight Study: Early Identification of Post-Surgical Infections Using Bedside Ultrasound.

Introduction: The goal of this observational study is to learn whether point-of-care ultrasound (POCUS) can help detect early fluid build-up under the skin after open abdominal surgery (laparotomy) and whether these findings can predict surgical site infection. The study includes adults who recently had emergency or planned open abdominal surgery. Hypothesis: The main questions it aims to answer are: 1. Does ultrasound identify subcutaneous fluid collections early after surgery? 2. Do these fluid collections help predict which participants will develop a surgical site infection? Intervention: Participants will: 1. Have a superficial wound swab taken once at the start of the study (for research only). 2. Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery. 3. Have their wound checked for redness, swelling, tenderness, or discharge before each scan. 4. Be followed for 7 and 30 days after surgery (and up to 90 days if they have implanted mesh) to see whether an infection develops. Ultrasound is non-invasive and safe. According to the protocol, "no serious adverse effects are expected," though some participants may feel brief discomfort from pressure on a tender wound. This study will help researchers understand whether routine bedside ultrasound can support earlier detection of wound infections and improve postoperative care in the future.

Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection

Surgical site infections (SSIs) are frequent complications in neurosurgical patients, often worsened by perioperative hyperglycemia. This randomized, controlled trial will compare intensive glycemic control (continuous insulin infusion, 140-180 mg/dL) with standard care (subcutaneous insulin, 81-180 mg/dL) in 544 patients. The primary outcome is SSI occurrence within 90 days post-surgery. Results aim to guide optimal glycemic management for SSI prevention in neurosurgery.

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.

Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients.

This is a prospective randomized controlled trial conducted at Ain Shams University Maternity Hospital to compare subcutaneous drain versus wound irrigation with normal saline for the prevention of surgical site infection following cesarean section in obese patients. Eligible women were randomly assigned to either subcutaneous drain placement or intraoperative wound irrigation, or subcutaneous skin closure only. The primary outcome was the incidence of surgical site infection, with additional assessment of postoperative wound complications and recovery.