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Surgical Wound Infection clinical trials

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NCT ID: NCT01803490 Completed - Clinical trials for Surgical Site Infection, Closed Suction Drains

Bacterial Colonization of Suction Drains Following Spine Surgery

Start date: January 2013
Phase:
Study type: Observational

Closed suction drains are commonly used following surgery, if the wound is expected to discharge significant amounts of fluid. To this date, no evidence base exists as to the exact post operative time period or discharge volume necessitating presence of a drain. In orthopedic common practice, drains are removed on the second post operative day, fearing the drain will serve as a point of entry for nosocomial infection. In this study, drains will be left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of days following surgery. Daily cultures and antibiotic levels will be taken from the drains receptacle, to determine if and when the drains is colonized by aerobic bacteria.

NCT ID: NCT01798810 Completed - Clinical trials for Post Operative Surgical Site Infection

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery

OXYGEN
Start date: June 2013
Phase: N/A
Study type: Interventional

The OXYGEN Study is a double blinded prospective randomized controlled trial that will compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.

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: NCT01782573 Completed - Liver Tumors Clinical Trials

The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients

Start date: October 2011
Phase: Phase 4
Study type: Interventional

To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more effective on the reduction of surgical site microbial colonization and subsequent infection than is normal saline.

NCT ID: NCT01773694 Completed - Clinical trials for Surgical Wound Infection

Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries

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

Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is likely to decrease the risk of infection and bleeding. However, this has never been formally studied. Patient's routines are likely disrupted when they are asked to avoid wetting the area. The investigators will perform a controlled study to determine if avoidance of post-operative wetting is necessary.

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: NCT01741649 Completed - Clinical trials for Surgical Wound Infection

Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section

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

Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.

NCT ID: NCT01724255 Completed - Clinical trials for Patient Satisfaction

Optimal Time for Staple/Dressing Removal

Start date: January 2013
Phase: N/A
Study type: Observational

The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients: 1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1 2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4 3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1 4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7 5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7 Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.

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.