Clinical Trials Logo

Surgical Wound Infection clinical trials

View clinical trials related to Surgical Wound Infection.

Filter by:

NCT ID: NCT05852158 Recruiting - Clinical trials for Orthognathic Surgical Site Infection

Antibiotics for Prevention of Infection Following Orthognathic Surgery

Start date: January 9, 2024
Phase: Phase 4
Study type: Interventional

Orthognathic surgery describes a group of procedures aimed at correcting developmental or acquired deformities of the jaws and facial skeleton. The goal of these procedures is to improve speech, jaw and dental function, aesthetics, and symptoms of sleep apnea. This is accomplished by surgical repositioning of the upper jaw (maxilla) and lower jaw (mandible). The most common procedures are lefort I osteotomies (upper jaw repositioning) and bilateral sagittal split osteotomies (lower jaw repositioning). At our institution, almost all cases include one or both of these two procedures. The majority of cases include bilateral sagittal split osteotomies (BSSO). As access to the jaws is through the oral cavity, these procedures are considered to be clean-contaminated surgeries due to the high intra-oral bacterial load. The result is that surgical site infections (SSIs) occur in 10-15% of cases. Studies show that the vast majority of these infections occur in the lower jaw (BSSO sites), presumably due to pooling of saliva and debris. SSIs are associated with patient discomfort, prolonged hospital stays, increased morbidity, and increased cost to healthcare systems. The use of peri-operative antibiotics has been shown to significantly reduce the incidence of SSI following orthognathic surgery. There is currently no consensus on the dosing or specific antibiotic to be used. There is strong evidence that pre-operative antibiotics significantly decrease SSI compared to no antibiotics. However, to date, there is no good evidence to support the use of post-operative antibiotics to further decrease the rate of infection. Several studies have examined the use of post-operative antibiotics ranging between 1-7 days. The majority of studies were not able to demonstrate a statistically significant difference to justify the use of post-operative antibiotics. A systematic review by Danda and Ravi in 2011 suggested that there likely is a benefit to the use of post-operative antibiotics. Danda and colleagues in 2017 later conducted a trial comparing pre-operative antibiotics alone compared to pre-operative combined with post-operative antibiotics. A statistically significant difference was not found, however, they felt that this was due to a limited sample size. Overall, there is no robust data that supports the use of post-operative antibiotics. The World Health Organization guidelines currently recommend against the use of post-operative antibiotics in orthognathic surgery. However, they do comment that there is some weak evidence that suggests its use. It was deemed that this low quality evidence did not outweigh the potential harm of antimicrobial resistance, which results from inappropriate overuse of antibiotics. Antimicrobial resistance is a serious, growing problem which has deadly consequences. Our current protocol at the QEII Health Sciences Center for peri-operative antibiotic administration is a single pre-operative dose of 2g cefazolin IV, followed by further doses every 8 hours post-operatively for a total of 24 hours (3 post-operative doses). Our study aims to investigate whether there is a need for these additional post-operative doses. If there is a benefit to these additional doses, the research team aims to investigate whether this benefit outweighs the risks. This question is of great importance in order to avoid an unnecessary contribution to antibiotic resistance and unnecessary potential adverse effects. Participants will be assigned a study number and randomly allocated to one of two groups. Group A will receive a single pre-operative dose of 2g IV cefazolin. Group B will receive a pre-operative dose of 2g IV cefazolin, followed by an additional three doses post-operatively every 8 hours for a total of 24 hours. Informed consent will be obtained at each participant's pre-operative assessment in the days leading up to the procedure. The participant will then select a group designation from a sufficiently mixed jar, and group A or B will be assigned to their study number. For each patient, the procedures completed will be documented, along with age, sex, smoking status, length of procedures, and complications. Complications including medication adverse reaction (allergy, toxicity, side effects), surgical complications, and any other significant complications related to the medications or deemed to be relevant to infection risk will be documented. Procedures will be carried out in the standard fashion. Patients will receive the same post-operative instructions and will be discharged with a chlorhexidine mouth rinse to be used for two weeks. Patients will return for follow-up at 2 weeks, 4 weeks, and 6 weeks post-operatively. Surgical site infection diagnosis will be made according to the CDC criteria and will be reported as either superficial, deep, or organ/space infections. Date of occurrence, location of infection, and treatment provided will be recorded on a standard form provided to surgeons.

NCT ID: NCT05816135 Recruiting - Clinical trials for Surgical Site Infection

Investigation of Environmental Parameters in Operating Rooms

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Postoperative surgical site infection (SSI) is a serious and complicated healthcare-associated infection (HAI) affecting about 2% of patients undergoing orthopedic surgery. Exogenous infections, could occur from insufficient air quality in operating rooms as shown in previous studies. However, from our knowledge, no study have collect environmental parameters and cross referenced the data with recorded patient registries to see if insufficient air quality is associated with higher risk of exogenous SSI. Temperature, humidity and the difference in air pressure in relation to the operating room and the adjacent corridors are examples of environmental parameters that could affect the air quality in operating rooms. Number of persons during an operation and particle counts could also give an indication of insufficient air quality.

NCT ID: NCT05775341 Recruiting - Clinical trials for Surgical Site Infection

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

INTRA
Start date: February 27, 2023
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT05763602 Recruiting - Clinical trials for Surgical Site Infection

PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

POTENT
Start date: September 15, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF) will decrease the patients' risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus.

NCT ID: NCT05755789 Recruiting - Colorectal Surgery Clinical Trials

Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery

PROPHYLOXITIN
Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery. The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery

NCT ID: NCT05705843 Recruiting - Clinical trials for Infection, Surgical Site

IO vs IV Vancomycin in Tourniquetless TKA

Start date: January 25, 2023
Phase: Phase 4
Study type: Interventional

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

NCT ID: NCT05701475 Recruiting - Clinical trials for Surgical Site Infection

Cutibacterium Acnes: Triple Prevention in Shoulder Operations

C3PO
Start date: January 18, 2023
Phase: N/A
Study type: Interventional

Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention). Bacterial cultures will be collected during surgery of the surgical field and tissue layers. Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.

NCT ID: NCT05684198 Recruiting - Clinical trials for Surgical Site Infection

NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis

PRISTINE
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.

NCT ID: NCT05676801 Recruiting - Clinical trials for Surgical Site Infection

Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-III)

Start date: February 4, 2023
Phase: Early Phase 1
Study type: Interventional

The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis strategies for the prevention of surgical site infections.

NCT ID: NCT05647252 Recruiting - Elective Surgery Clinical Trials

General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery

BALGDEC
Start date: February 27, 2023
Phase: Phase 3
Study type: Interventional

The general decolonization of the human body surface by industrial antiseptic agents, before elective surgery is recommended by the World Health Organization (WHO). A specific randomized-controlled trial specifically among high-risk adult orthopedic patients for infection has not been performed. In this single-center, prospective, randomized, and controlled superiority trial, which is planned over a period of two years, we target on an orthopedic patient population with an elevated risk for revision surgery and surgical site infections