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Surgical Site Infection clinical trials

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NCT ID: NCT04577846 Not yet recruiting - Clinical trials for Surgical Site Infection

SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.

Start date: November 1, 2020
Phase: Phase 3
Study type: Interventional

Breast cancer is the second most prevalent malignancy in the world and an important component of treatment warrants surgical procedures such as mastectomy. Surgical site infections after breast surgery may range from 1-26%, which is high for surgeries that are considered "clean procedures", as defined by the Centers for Disease Control and Prevention (CDC) wound classification system. Prophylactic antibiotics given before the surgical incision as per Joint Commissions SCIP (Surgical Care Improvement Project) guidelines, have been shown to decrease the rate of postoperative infections in a vast number of patients. There is however, no clear consensus due to lack of evidence on continuation (duration) of prophylactic antibiotics in patients undergoing mastectomy with indwelling drains, and thus antibiotic prescribing practices may vary among breast as well as reconstructive surgeons. In this trial all patients undergoing mastectomy without immediate reconstruction will receive a single prophylactic dose of preoperative antibiotic, and subsequently, the patients will be randomized to either continue the prophylactic antibiotics or receive a placebo for the duration of indwelling drains. The aim of this trial is to compare the difference in SSI rates between these two study arms as the main outcome. In addition, the factors associated with differing rates of SSI in the intervention and control group will also be identified.

NCT ID: NCT04548661 Recruiting - Clinical trials for Surgical Site Infection

Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

A surgical site infection (SSI) is an infection that occurs after a surgical procedure. Despite a variety of infection prevention strategies, SSIs still occur often and impose a significant burden on patients and the healthcare system. Intraoperative irrigation (or washing of the surgical incision before closure) may reduce SSIs, but this is uncertain. The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation. 2,500 patients aged 18 years or older who are planned to undergo an abdominal or groin open or laparoscopic procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution; or incisional wound irrigation with saline; or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected up to 90 days after surgery. Even with significant advances in medicine over the past decades, there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence. If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI, these practice-changing findings could greatly benefit patients worldwide.

NCT ID: NCT04496635 Recruiting - Clinical trials for Surgical Site Infection

Surveillance and Implementation of a Bundle of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat)

CCR-VINCat
Start date: January 1, 2007
Phase: N/A
Study type: Interventional

The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30 days after surgery. Hospitals are classified according to their size into three groups: >500 hospital beds; 200-500 beds; <200 beds. Aim. To examine the effect on SSI rate of a specific preventative bundle in elective colorectal surgery. Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. To compare the results of SSI before (baseline phase, BP) and after the bundle implementation (implementation phase, IP) a logistic regression model has been established. The results will be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance level will be fixed at 5% (P < 0.05).

NCT ID: NCT04496180 Not yet recruiting - Clinical trials for Surgical Site Infection

Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

CiPNT/SSI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections. Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.

NCT ID: NCT04476212 Recruiting - Clinical trials for Surgical Site Infection

Prophylaxis of Surgical Wound Infection With Topical Antibiotics

Start date: December 27, 2018
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.

NCT ID: NCT04446923 Completed - Clinical trials for Surgical Site Infection

Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing

Start date: June 28, 2020
Phase: Phase 4
Study type: Interventional

The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

NCT ID: NCT04411199 Recruiting - Clinical trials for Surgical Site Infection

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

D-PLEX312
Start date: December 6, 2020
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04401553 Withdrawn - Clinical trials for Surgical Site Infection

Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

Start date: August 16, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04366440 Active, not recruiting - Clinical trials for Surgical Site Infection

De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children

OPerAtiC
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04350203 Completed - Clinical trials for Surgical Site Infection

Surgical-Site Infection After Laparoscopic Right Colectomy

Start date: January 1, 2011
Phase:
Study type: Observational

Laparoscopic right colectomy with intracorporeal anastomosis seems to be associated with several short-term benefits. It could reduce the postoperative infection rate and shorten the hospital stay. This study aimed to evaluate the postoperative surgical site infection (SSI) rate after laparoscopic right hemicolectomy with intracorporeal anastomosis, compared to extracorporeal anastomoses.