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Surgical Wound Infection clinical trials

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NCT ID: NCT02390401 Terminated - Clinical trials for Surgical Wound Infection

Vacuum Assisted Closure for Cesarean Section

VACCS
Start date: May 2015
Phase: Phase 1
Study type: Interventional

To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

NCT ID: NCT02307084 Terminated - Clinical trials for Surgical Wound Infection

Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

Start date: February 2015
Phase: N/A
Study type: Interventional

The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.

NCT ID: NCT02280395 Terminated - Clinical trials for Post Operative Wound Infection

A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects undergoing abdominal surgery.

NCT ID: NCT02255487 Terminated - Clinical trials for Surgical Site Infection

Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

Start date: February 18, 2015
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.

NCT ID: NCT02221232 Terminated - Clinical trials for Surgical Site Infection

Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™

ZX-ZP-0035
Start date: August 2014
Phase: Phase 2
Study type: Interventional

The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.

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: NCT01583062 Terminated - Clinical trials for Surgical Wound Infection

Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

Start date: January 2006
Phase: Phase 4
Study type: Interventional

Facial fractures make up a significant proportion of injuries in trauma patients. Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today. Chole and his team could show that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of an postoperative infection. Up to date there is no standard to support the administration of antibiotics after surgical repair of a facial fracture. The purpose of this prospective, randomized double-blinded trial is to investigate the utility of antibiotics administered in the postoperative period after surgical revision of facial fractures. Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective as a long-term administration of 5 days in facial fractures.

NCT ID: NCT01577524 Terminated - Clinical trials for Surgical Site Infection

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections.

NCT ID: NCT01540279 Terminated - Clinical trials for Wound Infection, Surgical

Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures

Start date: July 2011
Phase: N/A
Study type: Observational

Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades. Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups. Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.