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Surgical Wound Infection clinical trials

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NCT ID: NCT06035627 Recruiting - Clinical trials for Surgical Site Infection

The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.

Start date: May 15, 2023
Phase:
Study type: Observational [Patient Registry]

There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.

NCT ID: NCT06014788 Recruiting - Clinical trials for Postoperative Wound Infection Deep Incisional Surgical Site

Is the NPWTi Better Than the Conventional NPWT

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in superficial and deep surgical site infections using an improvised system with continuous lavage with saline and chlorhexidine. The main question it aims to answer is whether the NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional NPWT. Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent infections and the number of reoperations, shortens the hospital stay, and alleviates the burden on the hospital staff in comparison to the conventional NPWT.

NCT ID: NCT06014411 Recruiting - Surgical Wound Clinical Trials

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

EVDB
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

NCT ID: NCT05989386 Recruiting - Clinical trials for Surgical Site Infection

Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

Start date: April 29, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are: - Incidence of SSI after intervention - Length of hospital stay Participants will be randomly assigned to two groups receiving either of the two groups: Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation. Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.

NCT ID: NCT05966961 Recruiting - Clinical trials for Surgical Site Infection

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

POLYNOVO-CHD
Start date: September 18, 2023
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT05959603 Recruiting - Infection Clinical Trials

Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery

Start date: May 31, 2020
Phase: Phase 3
Study type: Interventional

Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.

NCT ID: NCT05930639 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

One of the most effective treatment methods of obesity is surgery. Bariatric surgery is classified as a clean-contaminated wound. The expected benefit from surgery is weight loss. However, surgical site infection is among the complications. Although many methods are applied to reduce these rates, it is not very possible to reduce them to zero. It is predicted that the incidence of infection will decrease with surgical care packages created from the combination of evidence-based interventions applied. This study was a randomized controlled trial designed to determine the effect of the Surgical Site Infection (SSI) prevention package on SSI and patient comfort in patients undergoing bariatric surgery. The questions to be answered by the research are; - What is the effect of the care package applied to patients undergoing bariatric surgery on surgical site infection? - What is the effect of the care package applied to patients undergoing bariatric surgery on comfort? .Patients aged 18 and over who have had bariatric surgery (sleeve gastrectomy) will be taken from a private hospital in Kayseri. All surgeries will be performed by the same surgeon. The care package (identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education) prepared for the experimental group will be applied. On the 30th day, the patient is called by phone and the surgical site infection findings are questioned.

NCT ID: NCT05920122 Recruiting - Clinical trials for Surgical Site Infection

Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections

Start date: October 9, 2023
Phase: Phase 4
Study type: Interventional

This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.

NCT ID: NCT05863832 Recruiting - Clinical trials for Surgical Site Infections

Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole

CIPRO-001
Start date: August 17, 2021
Phase: Phase 4
Study type: Interventional

This study aims to assess the safety & efficacy of Oral Ciprodiazole® versus currently used Ciprofloxacin Tablets & Metronidazole tablets in pelvi-abdominal infections and following IV antibiotics in post-operative period, for pelvi-abdominal surgeries or acute conditions

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.