Surgical Site Infection (SSI)

16

Review clinical trials related to Surgical Site Infection (SSI). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sylhet M.A.G.Osmani Medical CollegeUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Patients aged 18 years and above [+2]

Patients with known hypersensitivity to levofloxacin or other fluoroquinolones [+4]

Status: Not yet recruiting

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.

Participants needed: 114
Trial details
Phase: Phase 4Age: 18+Biological sex: MaleType: InterventionalSponsor: Universität LuzernUpdated: Jun 29, 2026Locations: 1
Eligibility criteria

Age more than 18 years [+2]

Emergency spine surgery [+8]

Status: Not yet recruiting

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).

Participants needed: 100
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Helwan UniversityUpdated: Jun 24, 2026
Eligibility criteria

Orthopaedic surgical ward patients who underwent major surgery.

Patients who require reoperation within 30 days. [+3]

Status: Not yet recruiting

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).

Participants needed: 100
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Helwan UniversityUpdated: Jun 24, 2026
Eligibility criteria

Cardiothoracic ICU-admitted patients who underwent CABG on CPB.

Patients who require reoperation within 30 days. [+4]

Status: Not yet recruiting

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

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University Hospital Hradec KraloveUpdated: Jun 12, 2026
Eligibility criteria

Adult female patients scheduled for planned abdominal surgery for gynecologic or...

Failure to provide informed consent.

Status: Not yet recruiting

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.

Participants needed: 1,000
Trial details
Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Jun 15, 2026Locations: 1Duration: 24 Months
Eligibility criteria

Emergency Caesarean section. [+2]

Elective or non-bellwether surgeries. [+2]

Status: Recruiting

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.

Participants needed: 655
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital AugsburgUpdated: May 29, 2026Locations: 1
Eligibility criteria

Adult patients (≥18 years) [+1]

Emergency laparotomy. [+3]

Status: Not yet recruiting

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.

Participants needed: 250
Trial details
Phase: Phase 3Age: 18-84Biological sex: AllType: InterventionalSponsor: Johns Hopkins Bloomberg School of Public HealthUpdated: May 8, 2026Locations: 18
Eligibility criteria

Age 18-84 years [+2]

Spine fractures [+8]

Status: Not yet recruiting

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.

Participants needed: 82
Trial details
Biological sex: AllType: InterventionalSponsor: Pak Emirates Military HospitalUpdated: May 12, 2026
Eligibility criteria

Patients undergoing elective surgical procedures, such as excision of benign or...

1.Patients on anti-coagulants.

Status: Not yet recruiting

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.

Participants needed: 572
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Sao PauloUpdated: Apr 23, 2026
Eligibility criteria

Adults aged ≥18 years [+1]

Patients who underwent any surgical or neurosurgical procedure within 30 days pr... [+5]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Slagelse HospitalUpdated: Apr 24, 2026Locations: 3
Eligibility criteria

Adults >18 years. [+4]

Laparoscopic surgery [+3]

Status: Not yet recruiting

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

Participants needed: 164
Trial details
Phase: Phase 4Age: 1-18Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

Age Range: Paediatric patients from birth (neonates) up to 18 years of age. [+3]

Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induc... [+6]

Status: Recruiting

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.

Participants needed: 240
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Doron KabiriUpdated: Apr 2, 2026Locations: 1
Eligibility criteria

Patients undergoing elective cesarean section at Hadassa medical center [+1]

Patients undergoing emergency cesarean section [+2]

Status: Recruiting

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.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Beni-Suef UniversityUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

female participants with singleton pregnancies scheduled for elective cesarean s... [+3]

Cases of urgent or emergent CS. [+6]

Status: Recruiting

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

Participants needed: 500
Trial details
Biological sex: AllType: InterventionalSponsor: Ming YangUpdated: Jan 30, 2026Locations: 1
Eligibility criteria

Patients with a pathologically confirmed primary or metastatic central nervous s... [+4]

Presence of active systemic or local surgical site infection before surgery. [+5]

Status: Not yet recruiting

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.

Participants needed: 156
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Lady Reading Hospital, PakistanUpdated: Dec 15, 2025Locations: 1
Eligibility criteria

Age: 18-70 years. [+4]

Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds. [+6]