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75 active trials for Surgical Site Infection

Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective way to prevent surgical site infections. The beta-lactam are the most frequent antibiotics recommended for surgical prophylaxis and patients known to be allergic to beta-lactam are more likely to presented surgical site infection, probably due to use of others antibiotic such as vancomycin or clindamycin. The main objective of the study is to describe the tissu and plasma pharmacokinetics of vancomycin, clindamycin and gentamicin using as surgical antibiotic prophylaxis in patients with beta-lactam hypersensivity and to predict the probability of target attainment for usual bacteria.

Start: May 2019

D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated control arm, in prevention of post abdominal surgery incisional infection.

Start: June 2020

Surgical Site Infection and Antibiotic Use Study

This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.

Start: March 2021

Pre-operative Risk Assessment of Surgical Site Infection After Cardiac Surgery

Surgical site infections (SSI) are serious complications accounting for 20% of all the healthcare-associated infections and are considered the second most frequent type of hospital-acquired infection in Europe and the United States. SSI after cardiac surgery is associated with delays to patient's discharge, readmissions and re-operations; and can result in increased hospital costs for staffing, diagnostics and treatment. Risk assessment has been identified as potentially useful intervention in SSI prevention and in identifying at risk populations who may benefit from specific interventions to reduce this possible complication of cardiac surgery. However, there is currently a lack of evidence as to which risk tools are the most valid and reliable to be used in clinical practice. The investigators developed and locally validated the Barts Heart Centre Surgical Infection Risk (B-SIR) tool to include patients with various types of cardiac surgeries and found that the B-SIR tool is a better tool in predicting SSI risk compared with the existing cardiac risk tools in the study population. However, various literatures recognised that the predictive performance of a risk model tends to vary across settings, populations and periods. Hence, the investigators aim to do a multi-centre validation of the newly developed B-SIR tool and apply all the other tools (Australian Cardiac Risk Index and Brompton and Harefield Infection Score) to identify what tool performs best that can potentially be use for the UK population. Further, the outcome of the study will be beneficial to future cardiac surgery patients to assess their risk of developing SSI and help identify those patients who may benefit from specific interventions. Existing patients' data, which will be anonymised, from the participating cardiac centres will be utilised to analyse and compare the performance of each risk tools.

Start: June 2021

Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.

Start: August 2021

ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

This is a Phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor) multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of three in-theatre interventions to reduce SSI rates in patients undergoing surgery with an abdominal incision. ROSSINI 2 is a non-factorial superiority design with allocation of various combinations of the three interventions to be used during the same operation, via seven possible treatment arms plus one control arm initially.

Start: March 2019

COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"

The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.

Start: February 2021

Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Start: February 2020

Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Clean-wounds

Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-wound surgery (laparoscopic).

Start: February 2020

Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection

DESIGN: Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio. POPULATION: Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason. OBJECTIVES: The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection. Secondary objectives are: Incidence of urinary tract infection after urinary catheter removal. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus). Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. DESCRIPTION OF THE INTERVENTION: In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.

Start: May 2019

SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.

Start: May 2019

Tumescent Anesthesia Antibiotic Delivery (TAAD)

This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath

Start: December 2021

Use of Preoperative and Postoperative Antimicrobial Treatment

In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups. One group will receive a single treatment with an antibiotic at induction The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic

Start: March 2021

Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care resources including prolonged hospitalization and increased hospital readmission. Perioperative antibiotic prophylaxis is one of the most important strategies for prevention of SSI. If there is a beta-lactam allergy, second tier antibiotics (vancomycin and clindamycin) are recommended alternatives to first- and second-generation cephalosporins because of fears of possible allergy. This prospective, randomized, and single-blinded clinical trial is designed to examine causality between second tier antibiotics use and surgical site infections in the subjects with a documented unverified penicillin allergy. Unverified beta-lactam allergy could be associated with antimicrobial treatment failure with second tires antibiotics during postoperative period.

Start: May 2021

Wound Contamination During Orthopaedic Surgery

In the present study we will compare bacteriological findings and the incidence of SSI in relation to laminar airflow (LAF) ventilated ORs, conventional (also called displacement or mixed) ventilated ORs and conventional ventilated ORs with the addition of tables equipped with units providing a local LAF over the surgical instruments. The hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.

Start: September 2019

Zonulin Biomarker for Diagnosis of Hip and Knee Infections

Prior studies investigating the etiopathogenesis of surgical site infection (SSI) traditionally suggested three main ways for the infection to occur: local contamination occurring during the surgery, hematogenous translocation of bacteria during concomitant bacteraemia, and contamination from adjacent infected tissues by the progression of the infective process. While most of the research on SSI focused on minimizing any source of pathogens at the time of the surgery, emerging evidence shows how acute and chronic SSI can emerge more often from bacteraemia or other tissues in the body, such as the gastrointestinal system, especially when dysbiosis and high permeability are retrieved. Intercellular tight junctions (TJs) tightly regulate paracellular antigen trafficking. TJs are extremely dynamic structures that operate in several critical functions of the intestinal epithelium under both physiological and pathological circumstances. This paradigm was subverted in 1993 by the discovery of zonula occludens 1 (ZO-1) as the first component of the TJ complex 11 now being comprised of more than 150 proteins, including occludin, claudins, junctional adhesion molecules (JAMs), tricellulin , and angulins . However, despite major progress in our knowledge on the composition and function of the intercellular TJ, the mechanisms by which they are regulated are still incompletely understood. One of the breakthroughs in understanding the role of gut permeability in health and disease has been the discovery of zonulin, and the only physiologic intestinal permeability modulator described so far. Since then, zonulin has been used as a marker for increased intestinal permeability and associated with soluble CD14 (sCD14) and lipopolysaccharide (LPS), other common markers associated with surgical complication, inflammation, and bacterial translocations. As such, Zonulin could be a biomarker for mid- and long-term complications after total joint replacement such as infection, loosening, and mechanical complications associated with painful symptomatology.

Start: November 2020

Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion

Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate of SSIs after instrumented spinal fusion surgery. Secondary aims of the study are the incidence of vancomycin-related complications, vancomycin-resistant bacterial infections in the treatment arm as well as the rate of revision surgeries due to SSIs.

Start: October 2019

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery. Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.

Start: November 2020

Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds New Title Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds

The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). In April of 2020 a petition was made to add gentamycin and remove bacitracin after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted has removed bacitracin from its formulary. The modification was approved.

Start: October 2018

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

Start: July 2019