Clinical Trials Logo

Surgical Site Infection clinical trials

View clinical trials related to Surgical Site Infection.

Filter by:

NCT ID: NCT03257202 Completed - Clinical trials for Surgical Site Infection

Topical Treatment and Prevalence of P. Acnes

Start date: September 11, 2017
Phase: Phase 2
Study type: Interventional

This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.

NCT ID: NCT03226626 Not yet recruiting - Sepsis Clinical Trials

Tumescent Anesthesia Antibiotic Delivery (TAAD)

TAAD
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath

NCT ID: NCT03221023 Recruiting - Clinical trials for Surgical Site Infection

Intrawound Vancomycin Prophylaxis for Neural Stimulator

IV-DIRT
Start date: September 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.

NCT ID: NCT03199911 Completed - Clinical trials for Surgical Site Infection

Topical Antibiotic Prophylaxis for Eyelids

Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.

NCT ID: NCT03187106 Completed - Clinical trials for Surgical Site Infection

Prophylactic Antibiotics After Cesarean

PACT
Start date: August 1, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.

NCT ID: NCT03161262 Completed - Clinical trials for Surgical Site Infection

SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes

Start date: June 9, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether low-cost Short Message Service (SMS)-based follow-up medication reminders and surveys for surgical site infection (SSI) reporting can improve outcomes by increasing medication adherence and earlier detection and care of SSI. This will be a prospective study involving enrollment of patients onto the Memora Health platform, a web application developed for automating SMS content to patients. Post-operative patients will be identified by providers and enrolled prior to discharge, after which they will be followed for 3 months. Primary endpoints include medication adherence and patient satisfaction with the text messaging tool. Secondary endpoints include early detection of SSIs, patient satisfaction with overall post-discharge care and health-related quality of life, and pertinent 30-day readmissions.

NCT ID: NCT03141450 Completed - Clinical trials for Surgical Site Infection

Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB

Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.

NCT ID: NCT03112317 Completed - Clinical trials for Surgical Site Infection

Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

Start date: May 30, 2019
Phase:
Study type: Observational

This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery.

NCT ID: NCT03081962 Recruiting - Clinical trials for Surgical Site Infection

Effect of a Combination of Bundles on Surgical-site Infection After Elective Colorectal Surgery

Start date: February 15, 2017
Phase: Phase 3
Study type: Interventional

A prospective randomized clinical trial will be performed. Patients will be randomized in 2 groups. The experimental group will undergo the combined application of intraperitoneal irrigation with clindamycin and gentamicin solution, fascial closure with Triclosan-impregnated sutures and application of mupirocin ointment over the skin staples, in addition to the standard care measures. The control group undergo only the standard care measures. Incisional surgical-site infection will be investigated.

NCT ID: NCT03075813 Completed - Clinical trials for Surgical Site Infection

Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study

Early 2RIS
Start date: March 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this quality improvement study is to measure the effectiveness of surveillance using optimized statistical process control (SPC) methods and feedback on rates of surgical site infection (SSI) compared to traditional surveillance and feedback. The primary objective is to determine if hospital clusters randomized to receive feedback from optimized SPC surveillance methods collectively have lower rates of SSI compared to hospital clusters randomized to receiving feedback from traditional surveillance methods. Secondary objectives are 1) to estimate and compare the number of signals identified using optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the time and effort required to investigate signals generated using optimized SPC methods and traditional surveillance methods; and 3) to estimate the number and proportion of false-positive signals identified using optimized SPC methods and traditional surveillance methods. The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial using stepped wedge design. The active component of the quality improvement study will be performed in 29 DICON hospitals over three years, from March 2017 through February 2020. Clusters randomized to intervention will receive feedback on increasing rates of SSI identified through optimized SPC methods. This intervention is expected to decrease the subsequent rate of SSIs by closing the feedback loop on SSI outcomes. Participating study hospitals will all be members of DICON, a network of 43 community hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides community hospitals access to consultative services from infection prevention experts, data analyses and benchmarking, and educational materials designed by faculty from Duke. This study is considered part of routine quality improvement measures and a part of previously established agreements between DICON and the community hospitals. Data flow and communication are outlined in detail in approved protocols determined to be exempt research by the DUHS IRB. Briefly, existing clinical data are extracted from participating hospitals' electronic medical record into discrete files according to DICON specifications. Then a de-identification process removes direct patient identifiers into a limited dataset. The majority of data collection will occur through methods already developed and utilized by study hospitals. In brief, each hospital routinely submits limited datasets to the DICON Surgical Surveillance Database, including the following variables: hospital, type of procedure, patient identifier, date of procedure, age, sex, surgeon identifier, start/stop times, ASA score, wound class, risk index, SSI (Yes/No), date of infection, type of SSI, location at diagnosis and organism. No identifiable patient or surgeon data are transmitted to the DICON Surgical Database. Data definitions and data collection methods are standardized across DICON hospitals. Following signal adjudication, additional data will be collected in a REDCap database to document actions and rationale.