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Surgical Wound Infection clinical trials

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NCT ID: NCT05856968 Not yet recruiting - Clinical trials for Overweight or Obese Women, Elective Lower Segment Cesarean Section

To Investigate the Effect of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection Among Over-weight or Obese Women Who Are Undergoing Elective Caesarean Section

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

This research aims to clarify the best way to perform subcutaneous tissue closure in overweight and obese patients undergoing caesarean section to reduce the occurrence of surgical site infections. This Study seeks to get some local perspective on the need for and type of subcutaneous fat closure in obese women undergoing cesarean section, thereby reducing Surgical Site Infection. This is a pilot; double- blinded randomized control trial, with balanced randomization (1:1) and parallel grouped study. The sample size calculated by Raosoft Sample Size Calculator Software determined that based on a margin of error of 5%, there would need to be 266 participants to give 90% confidence level to detect a significant difference between both arms of the study. Patients who are immune-compromised, those with anemia, requiring transfusion will be excluded from the study, also any mother who wishes not to participate. Patients will be reviewed 7 days post operatively. Wound complications will be identified by a questionnaire by telephone at 4 weeks and 3 months post operatively. Data will be collected from Specific closed answer questions. Data extraction sheet will be used to collect data for the patient. This information will be collected either from the docket, direct review or examination of the study participants. The research will be done at Victoria Jubilee Hospital. The Research will last six months.

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: NCT05841576 Completed - Clinical trials for Surgical Site Infection

Anaesthetic Management Guided by COMET Measurements

AIMED COMET
Start date: September 22, 2021
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) is a significant cause of morbidity and mortality, prolonged hospital stays and healthcare costs. Perioperative low tissue oxygen tension is associated with a high risk of SSI. Standard anaesthetic management guided by continuous monitoring of oxygen delivery with a non-invasive method of measuring mitochondrial oxygenation tension (mitoPO2) using the Cellular Oxygen METabolism (COMET) monitor may benefit the intraoperative oxygenation on the tissue level. This randomised, controlled, single-centre, parallel-arm, patient-blinded trial aims to investigate if standard anaesthetic management guided by mitoPO2 monitoring results in higher tissue oxygen tension including patients undergoing elective abdominal surgery. Anaesthetists in the intervention group strive to a minimum mitoPO2 of 66 mmHg. Patients in the control group receive standard care. The primary outcome is the difference in means of the mean mitoPO2 during surgery.

NCT ID: NCT05828550 Not yet recruiting - Clinical trials for Patients withInfections Caused by S.Aureus Like Skin Infections , Chest Infections , Surgical Site Infections , and Urinary Tract Infections

Detection of Efflux Pump Genes Mediating Ciprofloxacin Resistance in Staphylococcus Aureus Isolates in Sohag University Hospitals

Start date: May 2023
Phase: N/A
Study type: Interventional

Among multidrug-resistant bacteria, Methicillin-resistant Staphylococcus aureus (MRSA) isolates were recognized to be an important mortality factor in hospital infections and a major concern in health-care and community settings . The antibiotic-resistant of S. aureus is extended by various bacterial strategies, including limiting uptake of the drug, alteration of the drugtargets, production of druginactivating enzymes and the activation of efflux pumps that effectively remove antibiotics . Relying on the type of antibiotics, bacteria can apply one or more strategies. Specifically, localization of resistance genes in transferable genetic elements, such as plasmid and transposons , causing Horizontal transfer of resistance genes between bacterial strains . MRSA strains are resistant to nearly all beta-lactam antibiotics by producing an alternative penicillin-binding protein known as PBP2a . This protein is encoded by the mecA gene and has a low affinity to manybeta-lactam antibiotics. Furthermore, these strains often show resistance to a wide range of antibiotics . The use of fluoroquinolone for the effective infectious therapy is limited by presence of fluoroquinolone resistance . There are two mechanisms causing resistance to fluoroquinolone. The first one is attributed to mutations occurring in the quinolone-resistance determining region (QRDR) of topoisomerase IV encoded by grlA/grlB and DNA gyrase encoded by gyrA/gyrB; these mutations decrease the affinity ofthe drug. The other mechanism is mediated by efflux pumps which is less recognized . Recently, several efflux pumps have been identified for S. aureus including efflux pumps encoded by chromosome or plasmids. The efflux pumps norA, norB, norC, mdeA, sepA, mepA, sdrM and lmrS are encoded by chromosome while qacA/B, qacG, qacH, qacJ and smr are plasmid-encoded . Efflux pumps could be specialized for specific substrate or mobilized a wide varieties of different antibiotic classes . Despite, efflux pumps can potentially increase resistance to antibiotics in clinical isolates of S. aureus, few studies have been evaluated the individual and collective participation of the efflux system in resistant isolates . Therefore the aim of the study is to detect ciprofloxacin resistant strains of staphylococcus aureus isolates and to detect efflux pump genes ( norA , norB and norC ) mediating resistance in such strains.

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: NCT05797818 Completed - Clinical trials for Surgical Site Infection

Red Light Photobiomodulation and Topical Disinfectants

Start date: January 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.

NCT ID: NCT05788575 Completed - Clinical trials for Surgical Site Infection

Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy

Start date: July 2, 2018
Phase:
Study type: Observational

The surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. All patients undergoing surgery during this period were enrolled in the study. The data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which: - 5 months of continuous survey of hospitalized patients - 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material Surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days. For each surgery, information was recorded such as the type of surgery, duration, ASA score, prophylaxis.

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