Comparing ethanol lock therapy versus vancomycin lock in a salvation strategy for totally implantable vascular access device infections due to coagulase-negative staphylococci (the ETHALOCK study): a prospective double-blind randomized clinical trial.

OBJECTIVES: Little is known about efficacy and safety of ethanol lock therapy (ELT) to treat totally implantable venous access device (TIVAD) infections. The objective of this trial was to evaluate the effectiveness and safety profile of a local treatment with ELT without removal for TIVAD infection due to coagulase-negative staphylococci. METHODS: We performed a prospective, multicenter, double-blind, randomized clinical trial comparing the efficacy of 40% ELT versus vancomycin lock therapy (VLT) in TIVAD infections due to coagulase-negative staphylococci, complicated or not by bloodstream infection. RESULTS: Thirty-one patients were assigned to the ELT group and 30 to the VLT arm. Concomitant bacteremia was present in 41 patients (67.2%). Treatment success was 58.1 % (18 of 31) for the ELT arm and 46.7% (14 of 30) for the VLT arm (p = 0.37). The overall treatment success was 52.5% (32). The risk of treatment failure due to uncontrolled infections, superinfections, and mechanical complications did not differ significantly between participants receiving ELT (13 out of 31 [42%]) and those receiving VLT (16 out of 30 [53%]) with a hazard ratio of 0.70 (p = 0.343; 95% CI [0.34-1.46], Cox model). Catheter malfunctions were significantly more frequent in the ELT arm (11 patients versus 2 in the VLT group, p = 0.01). CONCLUSIONS: We found an overall high rate of treatment failure that did not differ between the ELT arm and the VLT arm. TIVAD removal must be prioritized to prevent complications (uncontrolled infections, superinfections, and catheter malfunctions) except in exceptional situations.

General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study.

BACKGROUND: It has recently been suggested that propofol exerts a protective effect on the occurrence of persistent pain after breast cancer surgery. We analysed data from a subcohort taken from a multicentre study to validate this information. OBJECTIVE: The objective of this article is to study the role of the agent used for maintenance of general anaesthesia on the occurrence of persistent pain, with adjustment for multiple pre and peri-operative variables using the generalised linear model. DESIGN: A prospective cohort study. SETTING: Four French university hospitals. PATIENTS: Three hundred and twenty-eight and 362 patients with full dataset, depending on the studied outcome. INTERVENTION: Questionnaires sent at the third and the sixth month after surgery. MAIN OUTCOME MEASURES: The risk of persistent postsurgical neuropathic pain (defined by the DN4 questionnaire) within 6 months after surgery, and the intensity of persistent pain at the sixth month. RESULTS: Axillary lymph node harvesting and previous history of peripheral neuropathy were independent risk factors of persistent postsurgical neuropathic pain, although older age was protective. The same independent risk factors, but not age, explained the intensity of persistent postsurgical pain at the sixth month after surgery. We did not find any effect of the general anaesthetic, whether halogenated agent or propofol, using either unadjusted or adjusted analyses based on covariates or propensity score. CONCLUSION: There does not appear to be a role for the anaesthetic protocol in the occurrence of persistent postsurgical pain. Other already well established hypotheses were confirmed. TRIAL REGISTRATION: ClinicalTrials.gov (ref. NCT00812734).