Clinical Research Directory

Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity

This randomized controlled trial aims to evaluate the efficacy of preoperative vaginal cleansing with 5% povidone-iodine in reducing postoperative infectious morbidity among women undergoing cesarean section. The primary outcomes include wound-related complications, while secondary outcomes include postoperative fever, endometritis, wound infection, and white blood cell count.

De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children

The overall objective of this study is to identify the best strategy to eliminate unnecessary antibiotic use after surgery in pediatric surgical procedures considered low-risk for an SSI. Based on literature and our preliminary data suggesting surgeons will not fully accept standardized order sets based on current guidelines, the investigators hypothesize that order set modification combined with ASP facilitation will outperform standard order set modification alone in de-implementing unnecessary postoperative antibiotic use.

Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is: Does NPWT decrease wound complications? Researchers will compare it against regular dressings to see if NPWT is superior.

Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method. Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions. Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups. The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.

D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.

Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section

The goal of this clinical trial is to evaluate whether local subcutaneous administration of gentamicin reduces the incidence of surgical site infection (SSI) following elective cesarean section. The study will also assess the safety of local gentamicin administration. The main questions this study aims to answer are: * Does local subcutaneous administration of gentamicin reduce the rate of superficial and deep surgical site infections within 30 days after elective cesarean delivery? * Are there differences between groups in postoperative complications, including wound healing, fever, need for additional antibiotic treatment, or hospital readmission? Researchers will compare women who receive local subcutaneous gentamicin at the surgical site in addition to standard antibiotic prophylaxis to women who receive standard antibiotic prophylaxis alone. Participants will: * Undergo an elective cesarean section according to standard clinical practice * Receive either local subcutaneous gentamicin administration or no local antibiotic administration, in addition to standard systemic antibiotic prophylaxis * Be followed clinically for signs of surgical site infection and other postoperative complications during hospitalization and at follow-up visits up to 30 days after surgery

Antibacterial-coated Sutures at Time of Cesarean

Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.

Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study

Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.

One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.

Tobramycin Injection to Prevent Infection in Open Fractures

The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.

The Inselspital Surgical Cohort Study

Personalizing surgical care is of enormous clinical relevance, when considering the number of patients undergoing surgery in Switzerland every year. Currently, personalization is based on underlying or coexisting disease or alterations of laboratory values, but there is no accepted biological test available that may predict success or failure of surgery. Surgical site infections are the most common form of hospital-acquired infections. While the relevance of bacteria, antibiotics and intensive care support is well accepted, the impact of the individual host response remains poorly understood. The Investigators hypothesize that postoperative alterations of the metabolome allow identification of predictors of surgical complications in general, and surgical site infections in particular.

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections. The main question this study aims to determine if: * Patients undergoing surgery develop transient intestinal dysbiosis * Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. From patients the following information and samples will be collected: * Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring * Intraoperatively: * Mucosal swabs * Blood from central venous catheter and portal vein * Mesenteric lymph node * Intestinal specimen * Bile * Subcutaneous biopsy * Postoperatively: * If a surgical site infection occurs samples from infected site

Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

Surgical site infections (SSI) are not uncommon, especially in specific high-risk groups including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized measures have been adopted to reduce surgical site infection, and the use of topical vancomycin powder has gained popularity in recent years. Given the lack of high-quality evidence for the use of topical vancomycin to reduce surgical site infections in open posterior spine surgery, which is currently the most common approach to spine surgery, it is crucial to study the use of vancomycin powder in reducing surgical site infections. This study is a prospective, single-blinded open label randomized controlled trial, with one arm of patients having local administration of 1g vancomycin powder which will be placed in the deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic surgeon, whereas the control arm will be without such application of vancomycin. Both arms of patients will still be undergoing the same operation procedures, as well as postoperative local wound drainage and wound care. This study will provide insights on the reduction rate in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of using topical vancomycin in reducing surgical site infection between different disease groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These proposed findings will provide valuable information for clinicians and institutions on future measures for surgical site infection of open posterior spine surgery.

Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios

This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.

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.

Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients

The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: Does this new closure method reduce infections and wound reopening? Does it improve healing, recovery, and overall patient outcomes? Researchers will compare patients who receive the new closure method to past patients who received the standard method to see if outcomes are better. Participants will: Receive the new closure method during their surgery (as part of standard care) Be followed during their normal recovery up to their 6-week follow-up visit Complete a short quality-of-life questionnaire (about 10 minutes) Have their recovery assessed, including healing, complications, and hospital use Researchers will also look at quality of life, heart complications, hospital readmissions, antibiotic use, scar appearance, and overall costs to understand the full impact of the new method.

Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery

The aim of this study was to compare the effectiveness of chlorhexidine versus saline in flushing the surgical area during colorectal cancer surgery. The primary outcomes included surgical site infection, postoperative complication rates, et al.

Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Following Extracorporeal Life Support

This study aims to evaluate a new wound treatment called cold atmospheric plasma (CAP) for patients receiving extracorporeal life support (ECLS). Patients on extracorporeal life support (ECLS) often develop wounds at the sites where tubes are inserted, and these wounds can be difficult to heal and prone to infection. cold atmospheric plasma (CAP) is a gentle, non-heat treatment that can kill bacteria, reduce inflammation, and promote wound healing. In this study, patients will be randomly assigned to receive either standard wound care alone or standard care plus cold atmospheric plasma (CAP) treatment. Researchers will compare both groups to see whether cold atmospheric plasma (CAP) can reduce infection, improve healing speed, and decrease the need for additional procedures. The study will also monitor safety to ensure the treatment is well tolerated. The goal is to find a more effective and safe way to improve wound healing in critically ill patients.

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.

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.

Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery

The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.

Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study)

This is a prospective randomized, controlled, unblinded, interventional feasibility study to evaluate if showering with post operative drains in place leads to an increase in complications. The patients included in the study will be those undergoing breast reductions and panniculectomies at Geisinger Medical Center. The patients will be randomized post operatively into one of two groups: 1) patients instructed to shower with drains in place, and 2) patients instructed not to shower while they have drains in place.