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Surgical Site Infection clinical trials

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NCT ID: NCT01914328 Completed - Clinical trials for Postoperative Complications

Postoperative Pulmonary Complications in Major Abdominal Surgery

PPC
Start date: June 2013
Phase:
Study type: Observational

The purpose of this study is to determine the incidence of pulmonary complications in patients undergone major abdominal elective surgery performed under general anesthesia.

NCT ID: NCT01831154 Completed - Diabetes Clinical Trials

The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the effects of three different glycemic treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1) postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to investigate the effects of the three glycemic treatment conditions on: 1) intraoperative blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of stay, in patients undergoing open-heart surgery.

NCT ID: NCT01790529 Completed - Clinical trials for Surgical Site Infection

Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis

Start date: February 2013
Phase: Phase 4
Study type: Interventional

Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance. The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior to the skin incision significantly reduces the risk of SSI, but the correct time point of drug administration remains unclear. Most studies recommend application of SAP directly prior to skin incision. Other studies, however, suggest that this is too late and more time between administration of the SAP and skin incision is necessary for optimal SSI prevention. A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes prior to skin incision. Due to the obvious importance of this controversy, we want to answer this question with a clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room located in front of the actual operating theatre, where the patient gets anesthesia. Therefore, the application of SAP will take place early, approximately between 75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre, which on average occurs later (approximately within the last 30 minutes before skin incision). We test the hypothesis that strategy A is more effective in preventing SSI than strategy B. We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at each study site and 2500 per study group). All patients will be followed in the hospital for SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as hip endoprosthesis or meshes). We expect this study to be completed within approximately 3 years.

NCT ID: NCT01789697 Terminated - Pain Clinical Trials

Text Message Study

Start date: September 2012
Phase: N/A
Study type: Interventional

The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.

NCT ID: NCT01764750 Terminated - Clinical trials for Surgical Site Infection

Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics

Start date: January 2013
Phase: Phase 1
Study type: Interventional

Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially catastrophic consequences. Given this, the high cost of treatment, and a payer system unable to support such expenses, investigators must make every effort to find new cost-effective ways to prevent these complications. Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin into spinal surgery wounds immediately prior to wound closure. This method, known as "intrasite" application, is adapted from techniques used to prevent infection in joint replacement surgeries. The motivation for this practice is to maximize antibiotic concentration within the wound while minimizing systemic concentration and toxicity, (the inverse of the situation when using IV antibiotics). While the popularity of intrasite delivery has grown rapidly, this has occurred without prospective scientific evidence. Recently, three retrospective papers including nearly 2,500 treated patients, indicated that intrasite Vancomycin reduces wound infections without increasing adverse events[1-3]. However, there are no published data on the dosing or pharmacokinetics of intrasite Vancomycin, let alone prospective trials of its efficacy and safety. The investigators propose to perform the first prospective trial of intrasite Vancomycin pharmacokinetics and safety. Study objectives will include standardizing application and dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal potency, and dose selection for use in future studies. This will be accomplished by enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous blood and wound seroma fluid will be measured at regular intervals after surgery to establish pharmacokinetic parameters. Preliminary data regarding local and systemic adverse events including wound healing, fusion rate, and toxicity will be prospectively collected. The ultimate goal of this learning-phase study is to gather sufficient information regarding application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare for a Phase III efficacy trial.

NCT ID: NCT01713751 Completed - Clinical trials for Surgical Site Infection

Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

Start date: March 2012
Phase: N/A
Study type: Interventional

The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

NCT ID: NCT01697748 Completed - Post Operative Pain Clinical Trials

Prospective Study on Cesarean Wound Outcomes

Start date: September 2013
Phase: N/A
Study type: Interventional

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads. The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

NCT ID: NCT01679379 Completed - Clinical trials for Surgical Site Infection

Wound Infection in Obese Women After Cesarean Delivery

Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the surgical site infection rate and patient satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean section in obese women.

NCT ID: NCT01659983 Completed - Clinical trials for Surgical Site Infection

Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis

Start date: November 2012
Phase: Phase 3
Study type: Interventional

Research hypothesis: Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure. Study design: This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis. Setting: Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital Participants: Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis. Outcome: Superficial surgical site infection Period of study: August 2012 - August 2014

NCT ID: NCT01648088 Completed - Clinical trials for Surgical Site Infection

Detection of Staph Colonization in Pre-op Arthroplasty Patients

Staph
Start date: September 1, 2012
Phase:
Study type: Observational

This study will evaluate which body site(s) provide the best source of possible staph presence in participants undergoing total joint arthroplasty. If the pre-operative cultures indicate staph presence, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. Participants will be followed for 2 years post-implantation of prosthetic joint to monitor development of prosthetic joint infection.