Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Postoperative Wound Infection Superficial IncisionalPostoperative Wound Infection Deep Incisional Surgical SiteThis study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study.
Effect of Copper on the Healing of Obstetric Wounds
Cesarean Section; InfectionPerineal Infection2 moreThe most common complication of vaginal delivery is perineal tearing with a prevalence of 85% and 70% will need suturing. The caesarean section rate worldwide is rising and the rate in Croydon University Hospital is in the region of 25% of all deliveries. One in ten women will develop a wound infection of their perineal tear or caesarean section wound. Wound infection can cause pain, dehiscence, delayed wound healing, prolonged hospital stay, readmissions and interfere with a woman's ability to nurture their baby and enjoy motherhood. Copper has shown to have strong antimicrobial properties, with the ability to kill various bacteria including MRSA. It has also been shown that copper promotes new blood vessel formation and therefore enhance wound healing. This study is to investigate the effect of copper impregnated dressings and maternity pads on wound infection. Women will be randomised for a wound dressing or maternity pad with (study group) or without copper (control group). Both the clinician and the woman will be blinded to the randomised group. Wound infection will be assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. When wound infection is suspected, based on the questionnaire, a swab of the wound site will be taken to detect the causative bacteria.
Wound Infections Following Implant Removal
Surgical Wound InfectionIn the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs. With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up). If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.
Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
Diabetic FootDiabetic Foot Ulcer4 moreThe key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if this treatment is capable of reducing the bacterial population number within infected wounds. The investigators' lab recently discovered that a specific survival protein called catalase can be destroyed through blue light exposure. Given that a majority of bacteria species contains catalase, it is hypothesized that the destruction of this protein can improve the effectiveness of antimicrobial wound dressings commonly used to treat infected diabetic wounds, therefore further reducing the amount of bacteria within the wound and increasing the rate of healing. By reducing the overall bacterial population within these diabetic infected wounds, the ability for these diabetic wounds to heal will be enhanced, allowing for greater reductions in wound size over the course of the treatment. In this study, 40 subjects will be enrolled and randomly assigning subjects to either a control group or a phototherapy receiving experimental group. While control subjects will receive standard weekly debridement treatment procedures for infected diabetic ulcers, experimental subjects will receive standard weekly debridement treatment alongside 2 sessions of phototherapy every week over the course of 12 weeks. Bacterial swab samples will be taken alongside the excised debrided infect tissue for the purpose of bacterial population analysis. For each patient, the changes in total bacterial population, wound size, and subject satisfaction will be recorded and analyzed to determine the effectiveness of pulsed light phototherapy.
Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic...
Incisional HerniaWound InfectionThe aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh [Parietex Progrip (Medtronic) ] in order to prevent Incisional Hernia following midline emergent laparotomy in clean and clean-contaminated wounds.
The Use of Wound Protector in Whipple's Procedure With Intrabiliary Stent
Surgical Wound InfectionPancreatic NeoplasmsBackground: There are no published studies regarding the use of wound protectors in the context of surgical site infection (SSI) rates among patients receiving a pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative biliary stent placement for bile duct decompression represents the norm given typical surgical wait times. In addition to having higher associated lengths of hospital stay, ICU admissions, hospital re-admissions, and overall mortality, patients with SSI are also delayed, and often omitted, in their progression to critical oncologic adjuvant chemotherapy. As a result, SSI remain crucial and devastating complications for pancreas surgeons and their patients alike. Methods: The investigators will complete a randomized controlled trial evaluating the rate of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement when wound protectors are employed versus no wound protector use. This trial will employ block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB) surgeons will participate with a planned inclusion of all patients scheduled to undergo a pancreatoduodenectomy. Analysis: The investigators will use an intention to treat approach to the analysis. Categorical baseline data will be analyzed using the Fisher exact probability test. Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be determined using the Fisher exact probability test. Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a pancreatoduodenectomy with preoperatively placed intrabiliary stents. Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI following pancreatoduodenectomy, the epidemic incidence of this complication must be reduced. The additional crippling effect of refusing (Medicare) payment for any patient who receives a SSI in the United States has launched all techniques and analyses that can potentially reduce this complication into the National health care agenda. In Canada, health care utilization and economics are always a relevant and ever expanding area of importance. It is crucial that the investigators reduce complications such as SSI, regardless of individual payer sources.
Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection...
Surgical Wound InfectionThe purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk
Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious...
Infection; Cesarean SectionSurgical Wound Infection1 morePrevious studies have demonstrated that patients who undergo surgery while they under general anesthesia have fewer wound infections if they receive higher concentrations of oxygen but this has never been studied in women who are undergoing cesarean section. We plan to randomize women who are undergoing cesarean to receive either standard of care oxygen flow through a nasal cannula during their cesarean section only or a higher concentration of oxygen than they would typically receive through a face mask. Women will receive this therapy during their cesarean and for 2 hours afterwards. We will follow them after their surgery for evidence of infection either in their wound or their uterus.
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal...
Cardiac SurgerySternal Wound InfectionThe purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.
Preoperative Bath in Patients Submitted to Hip Arthroplasty
Surgical Wound InfectionClinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.