Neoplasms

Symptoms and General Pathology

All Conditions

Cysts

Pathological Conditions, Anatomical

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Cefazolin

Antibiotics, Antitubercular

During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care.

In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints.

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Peripheral intravenous cannula (IVC)

cefazolin

Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. To prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.

Penetration of Cefazolin Into Hepatic Cysts

An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.

Radboud University Medical Center

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.

Patients undergo standard of care surgical resection.

Undergo standard of care surgical resection

Resection

Emily Z Keung

This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.

PRIMARY OBJECTIVE:

I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.

SECONDARY OBJECTIVES:

I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.

II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.

ARM B: Patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.

The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy

The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.

By analysis of composition of circulating immune cell populations and cytokines.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Infections

Wounds and Injuries

Breast Neoplasms

Communicable Diseases

Wound Infection

Breast Diseases

Central Nervous System Depressants

Anesthetics

The patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start of anesthetic induction

The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction

2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction

0.9% saline sterile by endovenous, once, at the moment of anesthetic induction

sterile saline

The patient will be submitted to a conservative oncologic breast surgery

oncologic breast surgery

Samples for quantitative cultures will be obtained in the operating room before antisepsis and the end of surgery. A sample is also collected with the same patterning, on the first postoperative day, immediately after the removal of the dressing placed in the operating room. Will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper.

Microbiology

FABIOLA SM CAMPOS, MD

Breast cancer is the most frequent malignancy in the female population Brazilian, except non-melanoma skin tumors. Surgery plays an important role in regional spot disease control and the definition of parameters for the adjuvant treatment indication. Surgical site infections (SSI) are defined as wound infections occur following invasive procedures, corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most common among patients surgical. SSIs should be examined as potential wound contamination surgical, understood as the number of micro-organisms in the body and / or tissue being operated. Considering this aspect, the cancer surgery breast are classified by their potential for contamination by clean. The use of antibiotics to prevent the SSI in mastectomies is not standardized in Handbook of National Health Surveillance Agency due to the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among services. So this randomized clinical trial to evaluate the influence of the use of Prophylactic antibiotics in SSI rates in oncological breast surgery.

KIND OF STUDY:

Primary, clinical, prospective, randomized, two-parallel-group, double-blind, controlled, interventional, analytical. SAMPLE CALCULATION: based on proportions observed in a previous study with and without antibiotic use in breast surgery (VEIGA-Filho, 2010) the number calculated patients per group was 62, with a significance level of 5% and power 80% of the test. SELECTION: will be selected in Mastology outpatient clinics 124 female patients to be undergoing breast surgery for malignancy. The selection of patients will be divided in two groups PLACEBO (N = 62): receive 0.9% saline 100 ml intravenously and CEFAZOLIN GROUP (N = 62): receive 2 g of cefazolin diluted in 0.9% saline by endovenous. In both groups will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper. Preoperatively will default collection in the region higher interquadrantes breast to be operated immediately above areolopapilar complex, which is not included in the designated area for collection. At end surgery and also in the first postoperative day, the sterile field will be positioned with fenestration on the wound. Tha material will be Standard microbiological methods used to identify microoganismos. 0.2 ml aliquots of each sample are plated on agar media hypertonic mannitol, selective for Staphylococcus sp, Sabouraud agar with chloramphenicol (0.05mg / ml), selective for fungi, agar EMB Teague, selective for enterobacteria, and agar blood, for the presence of hemolytic colonies. After 48 hours, the reading of the number of colony forming units will be held by a microbiologist. Patients are regularly monitored for the occurrence of infection, once a week for the first 30 days by a single surgeon. They will be used and the definitions of surgical site infection classifications adopted by CDC

Antibiotic Prophylaxis in Oncological Surgery of Breast

Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial

To evaluate the influence of antibiotic prophylaxis in surgical site infection rates

To evaluate the microbiota that infects the skin in oncological breast surgery

Fabiola Soares Moreira Campos

Department of gynecology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Ciprofloxacin

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients in this arm will receive Ciprofloxacin 400mg IV 120mn (prophylactic antibiotic) before their HDR brachytherapy

Patients in this arm will receive Cefazolin 2000mg IV 60mn (prophylactic antibiotic) before their HDR brachytherapy

Patients in this arm will not receive any prophylactic antibiotics before their HDR brachytherapy

Ciprofloxacin 400 mg IV 120mn before HDR brachytherapy

Marjory Jolicoeur, MD,MSc

Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.

INTRODUCTION:

High dose rate (HDR) brachytherapy boost with external beam is the current recommended treatment for intermediate and high risk prostate cancers (1, 2). HDR brachytherapy uses transperineal implant (at least 15 prostate catheters) to deliver the calculated dose though a robot that contains the radioactive source. Once treatment is completed, the implant is retrieved and a dressing with an antibiotic ointment is placed on the perineum for a few hours.

The procedure is performed under spinal anesthesia, transperineally following a sterile wash. The implantation is guided from the transrectal ultrasound (TRUS). The procedure contains a series of back and forth probe movements that raises the contamination risk of the implantation zone which is considered non-negligible. Brachytherapy patients undergo urinanalysis before the implantation and redo the test at the least urinary symptom.

The suspicion of a contamination risk of the urinary tract during the procedure has therefore led to antibiotic prophylaxis habit. This habit has been based on experts' opinion mainly motivated by the antibiotic prophylaxis use for TRUS guided biopsies of the prostate.

Literature on antibiotic prophylaxis use for prostate brachytherapy is limited, both on the use of intraoperative or post-procedure antibiotic prophylaxis and on the risk of infectious complications following the brachytherapy procedure.

The use of antibiotic prophylaxis for prostate brachytherapy is derived from urology studies based on prostate biopsies (3, 4). Nevertheless, biopsy procedure is completely different from the implantation used on brachytherapy. Moreover, biopsies are done transrectally with bacterial dissemination risk on blood circulation, while brachytherapy is done transperineally.

Current recommendations from American Brachytherapy Society (ABS) do not state on the use of antibiotic prophylaxis for brachytherapy prostate patients (5). Antibiotic prophylaxis is however cited as possibly useful. The European Society for Radiation and Oncology (GEC-ESTRO) does not comment on the need for antibiotic prophylaxis, but mentions cystitis as a possible complication for prostate brachytherapy (1, 2). It is important to consider that these recommendations are based on expert opinion (level of evidence V). Unfortunately, there is no randomized trial (level of evidence I) to guide the use of antibiotic prophylaxis for prostate brachytherapy.

The most current used molecule for the antibiotic prophylaxis of the urinary tract is Ciprofloxacin. Yet, Ciprofloxacin is linked to the upsurge of C. difficile and the use of this molecule is linked to the appearance of many bacterial strains resistant to antibiotics (6). Other antibiotics, like Cefazolin do not have the same association with C. difficile and other multidrug-resistant bacteria. Cefazolin is equally used as antibiotic prophylaxis for pelvic surgery. Investigators can suppose that Ciprofloxacin can be replaced by Cefazolin as an antibiotic prophylaxis for prostate brachytherapy, causing less harm.

Moreover, one study compared both antibiotics (Ciprofloxacin and Cefazolin) in the prophylactic use in 100 patients (7). Authors demonstrated equivalence between both drugs for the prevention of urinary contamination. Although the study was not designed to demonstrate equivalence and the observed effect may be due to low number of randomized patients.

Furthermore, this study has not demonstrated beyond any doubt the need of antibiotic prophylaxis for prostate brachytherapy. Investigators continue to be uncertain about the need of antibiotic prophylaxis, as the rate of urinary infections without antibiotic prophylaxis after prostate brachytherapy continues to be unknown.

Nevertheless, radiation side effects on the urinary function are well known and are systematically reviewed by validate questionnaires, such as International Prostate Symptom Score (IPSS) and are graded accordingly to the Common Terminology Criteria for Adverse Events (CTCAE) score.

In summary, there is no evidence in the literature of the need for antibiotic prophylaxis in prostate brachytherapy. Likewise, there is no evidence to support that if used, it should be Ciprofloxacin. Furthermore, in times of multidrug-resistant bacteria, it is important to decrease the use of these molecules. This is why the investigators propose a phase III randomized clinical trial to evaluate the risk of urinary tract infection in the presence or absence of antibiotic prophylaxis for prostate brachytherapy.

METHODS:

Hypothesis:

The investigators hypothesize that the risk of infectious complication of the urinary tract following prostate brachytherapy is the same with or without antibiotic prophylaxis.

Objectives:

Primary:

- Evaluate the rate of urinary tract infections following prostate brachytherapy.

Secondary:

* Evaluate the rate and grade of the urinary tract complications in the presence and absence of antibiotics.
* Evaluate the effect on the IPSS score in the presence and absence of antibiotics.
* Evaluate the rate of serious infectious complications related to brachytherapy.
* Evaluate the risk of colitis due to C. difficile in the 12 weeks following the brachytherapy

Patient selection:

Inclusion and exclusion criteria are described elsewhere.

Pre-implant evaluation (morning of the intervention):

* Urinary test and culture
* Bladder scan

Treatment:

The patients are treated by HDR brachytherapy boost with external beam according to the current standards. Current standard also premise that patients are followed up weekly by their doctor. During patient visits, urinary symptoms questionnaire is fulfilled and urinary tests are performed as needed.

In the study establishment, patient is seen the next day of the procedure to retrieve the urinary catheter left after the procedure. During this visit a bladder scan post-miction is performed to check the bladder residual volume.

Antibiotic prophylaxis:

Randomization in 3 arms: Ciprofloxacin 400 mg IV 120 mn pre-operative, Cefazolin 2g IV 60 mn pre-operative or no antibiotic prophylaxis.

Data gathering:

Patient is to be seen day of the procedure (day 0), the next day (day 1), 3 days after the procedure (day 3), one week after (day 7), 1 month (day 30) and 3 months after procedure (day 90). Patients will fulfill IPSS questionnaire, make urine tests and a bladder scan in every visit.

Patients will be seen weekly during the external beam treatment by their doctor. Patient's symptoms will be graded according to the RTOG score. In cases with suspicion of urinary tract infection or prostatitis during the treatments, the standard procedure with urinary tests will take place.

Statistical Analysis:

The basic assumption is the probability of no difference in bacteriuria and change in the IPSS score between the 3 arms.

Sample size:

A difference of 15% between the groups equates to an effect size of 0.24 which is the magnitude of Chi-square that needs to be detected, gives us a power of 83%. Calculation was done using the PASS software.

A total of 234 eligible patients (78 per arm) are required for a power of 92% and a risk of the first species of 0.05. Adjust for 10% of ineligibility, the number needed is 255 patients (85 per arm).

Data analysis :

Data reading and statistical analysis will be done by the Statistical Analysis Software (SAS) package.

Socio-demographic characteristics, IPSS scores and patient's clinical data will be described by descriptive statistics (means, standard deviation, proportions, etc.). Anova or Chi-square tests will be used to compare arms. Multivariate logistic regression models will allow us to determine the potential associations between our categorical dependent variables while controlling for both sociodemographic factors and especially for potentially confounding clinical variables.

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial

The rate of symptomatic urinary infections post HDR brachytherapy.

Urinary toxicities rate in each arm measured by the Common Terminology Criteria for Adverse Events (CTCAE) score. The following Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOC) will be included: Renal and urinary disorders, and Infections and infestations. The CTCAE score ranges from grade 0 to 5, where higher grade represents higher toxicity. Each presented toxicity will be assessed and scored. Each toxicity will be evaluated by its percentage of incidence in the sample. Each patient will also be evaluated by his worse toxicity (higher grade). The percentage of toxicities incidence and their severity will be compared between groups.

Evaluate International Prostate Symptom Score (IPSS) effects of prophylactic antibiotics. The IPSS Score ranges from 0 to 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. Mean scores will be compared between groups.

Evaluate the rate of serious infectious complications post HDR brachytherapy

To evaluate the risk of colitis due to C. difficile infection all patients with diarrhea or increased bowel movement (colitis symptoms) will be tested for C. difficile infection. The association between colitis and the presence of C. difficile infection will be evaluated by Chi-square in each group.

CR-CSSS Champlain-Charles-Le Moyne

Principal Investigator, MD, PhD

Precancerous Conditions

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Penicillins

-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.

-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.

-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision

Mary M Mullen, M.D.

A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial

Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.

Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications.

* Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery.
* The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Washington University School of Medicine

Arm A: No Antibiotic Prophylaxis Prior to Skin Incision

Arm B: Antibiotic Prophylaxis Prior to Skin Incision

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Diagnosis of diabetes mellitus

Diagnosis of HIV

Immunosuppressive medications

Steroid use

Diagnosis of hypertension

Diagnosis of congestive heart failure

Diagnosis of cardiac valvular disease

Diagnosis of coronary artery disease

Diagnosis of chronic kidney disease

Diagnosis of pulmonary disease

Mary M. Mullen, M.D.

Vulvar Wound Complications Compared Between the Two Arms

Diabetes mellitus

Hypertension

Congestive heart failure

Cardiac valvular disease

Coronary artery disease

Chronic kidney disease

Pulmonary disease

The number analyzed for each row equals the number of participants who had the listed pre-existing condition or medication.

Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection

Chose to not sit and to lie/stand when possible = yes

Chose to not sit and to lie/stand when possible = no

Regularly performed vulvar wound care = yes postop

Regularly performed vulvar wound care = no

Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no

Actively kept the vulva dry postop 1-2 days

Actively kept the vulva dry postop 3-7 days

Actively kept the vulva dry postop 8-14 days

Actively kept the vulva dry postop 14+ days

Actively kept the vulva dry postop for unknown # of days

Actively kept the vulva dry postop = no

Cleaned the vulva after urinating postop 1-2 days

Cleaned the vulva after urinating postop 3-7 days

Cleaned the vulva after urinating postop 8-14 days

Cleaned the vulva after urinating postop 14+ days

Cleaned the vulva after urinating postop for unknown # of days

Cleaned the vulva after urinating postop = no

Cleaned the vulva after having a bowel movement postop 1-2 days

Cleaned the vulva after having a bowel movement postop 3-7 days

Cleaned the vulva after having a bowel movement postop 8-14 days

Cleaned the vulva after having a bowel movement postop 14+ days

Cleaned the vulva after having a bowel movement postop for unknown # of days

Cleaned the vulva after having a bowel movement postop = no

The number analyzed in the rows below do not match the overall number of participants analyzed in some categories because the participant did not answer the question on the survey.

Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications

Only participants in Arm B who received antibiotic prophylaxis are evaluable for this outcome measure

Incidence of Adverse Events to Antibiotic Use

Overall Study

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy.

Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established.

Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy. Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established. Antibiotics will be changed according to the antibiotic sensitivity test of cultured microorganisms.

Chien-Wei Su, MD & PhD

This randomized prospective study aims to investigate whether prophylactic administration of antibiotics has an influence on inflammatory markers, liver function test results, or the incidence of post-procedural infection in patients with hepatocellular carcinoma (HCC) undergoing radiofrequency ablation (RFA).

Patients

1. This cohort study will prospectively enroll HCC patients undergoing RFA in Taipei Veterans General Hospital and Taipei Medical University Hospital.
2. The diagnosis of HCC is established by histology or on the basis of the findings of typical radiologic features in a 4-phase multidetector computed tomography (CT)scan or dynamic contrast-enhanced magnetic resonance imaging (MRI).
3. Inclusion criteria: tumor size less than 5 cm without extra-hepatic metastasis; the number of tumor was 3 or less; Child Pugh classification of liver function are grade A or B; and the absence of other major diseases that might complicate RFA.
4. Patients will be excluded from the study if they meet the following criteria. First, the patient's age is younger than 20 years or older than 80 years. Second, the patients have a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or non-hepatic malignancy. Third, the patients have received antibiotics within the last 2 weeks. Patients will be subsequently excluded when initial bacteriological sampling turned out positive (occult infection).
5. After disinfection of the skin surface and induction of local anesthesia with 1% lidocaine, RFA will be performed with real-time ultrasonography guidance, and the RF electrode will be advanced into the tumor. RFA device will be used the Cool-Tip Radiofrequency System (Radionics, Burlington, MA). With the Cool-Tip device, treatment will be performed with a single (2- or 3-cm active tip) needle electrode. Each tumor has 1-4 ablations per session, depending on the tumor size. If the tumor is adjacent to hollow viscera and can not be displaced with a safe margin of at least 2 cm by positioning the patient in an oblique or lateral position, 5% dextrose will be intraperitoneally instilled around the liver to displace the hollow viscera.
6. After RFA, all patients will undergo immediate follow-up ultrasonography to evaluate the possibility of bleeding or fluid accumulation. Dynamic CT scan or MRI will be done one month after all of the tumors ablated by RFA. When these will be confirmed residual tumors by showing contrast enhancement during the arterial phase and wash out in venous phase, a second session of RFA will be conducted. If viable tumors persist after two sessions of RFA therapy, treatment will be considered a failure. If no viable tumor is detected, the patient will be regularly followed-up with abdominal sonography every 3 months.
7. Tumor recurrence is suspected if there is elevated serum AFP level or new lesion detected by surveillance ultrasonography. These would be confirmed by dynamic CT or MRI. Local recurrence is defined as tumor recurrence at the same segment of a previous tumor site, while intra-hepatic distant recurrence is diagnosed when a new lesion occurs in a different segment of a previously treated tumor.

Randomization Patients who fulfilled the inclusion criteria will be immediately randomized to the two treatment groups by using consecutively numbered envelopes that contained the treatment assignments, which were generated by a computer-allocated random digit number, in a 1:1 ratio. Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy. Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established. Antibiotics will be changed according to the antibiotic sensitivity test of cultured microorganisms.

Infection Assessment All patients will be closely monitored with special emphasis on the detection of bacterial infection through the hospitalization period. A careful physical examination, complete white blood cell count, chest radiography, urine sediment, urine culture, ascitic fluid neutrophil count and culture (if available), and blood culture will be routinely performed before randomization. Physical examination will be performed at least once per day during hospitalization. If a new infection is suspected, the same procedures to assess infection would be performed at admission. New infections are suspected when there is fever (\>38°C), hypothermia (\<36°C), unexpected hemodynamic instability, tachypnea, new onset of chest symptoms, dysuria, abdominal pain, distention, as well as alteration of mental state. A central venous catheter or urinary catheter would be inserted only when clinically indicated.

Clinical Assessment and Follow-up Body temperature will be measured every 6 hour for 72 hour. Acetaminophen at 500 mg will be used when patients complain of pain or have a high grade fever over 39°C after the procedure. The numbers of peripheral blood leukocytes, as well as levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), creatinine, C-reactive protein (CRP) and infection signs as above descriptions will be determined before, and at 24 hour, 3-7 day and 4 week after ablation therapy. Dynamic CT scan or MRI will be done one month after all of the tumors ablated by RFA in order to estimate the effectiveness of RFA or HCC, and whether liver abscess, cholangitis, cholangitis and peritonitis will be present. If a new infection is suspected within one month after RFA, Dynamic CT scan or MRI will be done immediately. Post-procedure infection is defined on the Guideline for Prevention of Surgical Site Infection, 1999, Centers for Disease Control and Prevention (CDC).

Safety Assessment and Adverse Events Adverse events will be recorded by the investigators during hospitalization or at the 4-week out-patient follow-up visit.

Statistical Analysis Pearson chi-square analysis or Fisher's exact test will be used to compare categorical variables, while the Mann-Whitney U-test would be used to compare continuous variables.

Variables with statistical significance (p\<0.05) or proximate to it (p\<0.1) by univariate analysis underwent multivariate analysis using a Cox's forward stepwise logistic regression model. A two-tailed p value \<0.05 is considered statistically significant. All statistical analyses will be performed using the Statistical Package for Social Sciences (SPSS 19.0 for Windows, SPSS. Inc., Chicago, IL, USA).

The infection rate of patients with HCC after RFA, without special emphasis on antibiotics treatment, is 1.5-3%. Estimates of sample size are based on a infection rate assumed to be 1% for the prophylactic antibiotics group and 5% for the on-demand antibiotics group. The type I (alpha) error and type II (beta) error are set to 0.05 and 0.2, respectively. The sample size needed is estimated to be at least 282 patients per group. Taking into account an expected dropout or missing data rate of 5%, the sample size needed is estimated to be at least 594 patients. Consequently, we plan to enroll a total of 600 patients in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Penetration of Cefazolin Into Hepatic Cysts	NCT02368015	Hepatic Cyst	Peripheral intr... cefazolin	18 Years -	Radboud University Medical Center
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma	NCT04875728	Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag...	Cefazolin Resection	18 Years -	M.D. Anderson Cancer Center
Antibiotic Prophylaxis in Oncological Surgery of Breast	NCT02809729	Breast Neoplasm... Breast-Conservi... Wound Infection Antibiotic Prop...	Cefazolin sterile saline oncologic breas... Microbiology	30 Years - 75 Years	Universidade do Vale do Sapucai
Antibiotic Prophylaxis in Oncological Surgery of Breast	NCT02809729	Breast Neoplasm... Breast-Conservi... Wound Infection Antibiotic Prop...	Cefazolin sterile saline oncologic breas... Microbiology	30 Years - 75 Years	Universidade do Vale do Sapucai
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer	NCT03862170	Prostate Cancer	Ciprofloxacin Cefazolin	18 Years - 85 Years	CR-CSSS Champlain-Charles-Le Moyne
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions	NCT03578965	Premalignant Vu... Benign Vulvar L...	Cefazolin	18 Years -	Washington University School of Medicine
Prophylactic Antibiotics Before RFA for HCC	NCT02534961	Hepatocellular ...	Cefazolin	20 Years - 80 Years	Taipei Veterans General Hospital, Taiwan

Spots Global Cancer Trial Database for cefazolin

Every month we try and update this database with for cefazolin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cefazolin

Every month we try and update this database with for cefazolin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cefazolin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.