End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial-HOPExt.

BACKGROUND: Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs are used for liver transplantation. These ECD liver grafts are however known to be associated with a higher rate of early allograft dysfunction and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic hypothermic oxygenated machine perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury. METHODS: HOPExt trial is a comparative open-label, multicenter, national, prospective, randomized, controlled study, in two parallel groups, using static cold storage, the gold standard procedure, as control. The trial will enroll adult patients on the transplant waiting list for liver failure or liver cirrhosis and/or liver malignancy requiring liver transplantation and receiving an ECD liver graft from a brain-dead donor. In the experimental group, ECD liver grafts will first undergo a classical static cold (4 °C) storage followed by a hypothermic oxygenated perfusion (HOPE) for a period of 1 to 4 h. The control group will consist of the classic static cold storage which is the gold standard procedure in liver transplantation. The primary objective of this trial is to study the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative early allograft dysfunction within the first 7 postoperative days compared to simple cold static storage. DISCUSSION: We present in this protocol all study procedures in regard to the achievement of the HOPExt trial, to prevent biased analysis of trial outcomes and improve the transparency of the trial results. Enrollment of patients in the HOPExt trial has started on September 10, 2019, and is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03929523. Registered on April 29, 2019, before the start of inclusion.

No Benefit of Adductor Canal Block Compared with Anterior Local Infiltration Analgesia in Primary Total Knee Arthroplasty: A Single-Blinded Randomized Controlled Clinical Trial.

BACKGROUND: An adductor canal block (ACB) performed by an anesthesiologist is an established component of analgesia after total knee arthroplasty. Alternatively, surgeons may perform periarticular local infiltration analgesia (LIA) intraoperatively. We hypothesized that ACB would be superior to anterior LIA in terms of morphine consumption in the first 48 hours after primary total knee arthroplasty under spinal anesthesia. METHODS: This prospective controlled and blinded trial included 98 patients; 48 received an ACB plus sham (saline solution) anterior LIA, and 50 received a sham (saline solution) ACB plus anterior LIA. Both groups received posterior LIA with local anesthetic. The primary outcome was cumulative morphine consumption at 48 hours after surgery. Secondary outcomes were pain while resting, standing, and walking, rehabilitation scores, opioid-related side effects, and patient satisfaction. RESULTS: No difference in the primary outcome was found, and the 48-hour morphine consumption was low in both arms (28.8 ± 17.6 mg with ACB, 26.8 ± 19.2 mg with anterior LIA; p = 0.443). Pain scores were significantly better in the anterior LIA arm, but the differences were not clinically relevant. There were no differences in any other secondary outcome measures. CONCLUSIONS: LIA may be used as the primary option for multimodal postoperative pain management in patients undergoing primary total knee arthroplasty with spinal anesthesia. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Adherence to oral antibiotic therapy in patients with bone and joint infection: A pilot study.

OBJECTIVES: The management of bone and joint infections (BJI) is complex and requires prolonged antimicrobial therapy. Few data exist on adherence to anti-infectious treatment other than HIV, and none on BJI, even though compliance is considered as a major determinant of clinical outcome. This work aimed at evaluating adherence to oral antimicrobial treatment in patients with BJI. PATIENTS AND METHODS: This is a prospective observational blinded pilot study evaluating adherence by a 6-item questionnaire at 6 weeks (W6) and 3 months (M3) post-surgery. The primary endpoint was the proportion of patients with high, moderate and poor adherence at W6. Secondary endpoints included change in adherence between W6 and M3, and the exploration of potential variables influencing adherence. RESULTS: Analysis was performed on 65 questionnaires obtained from 43 patients including 35 with device-associated BJI. At W6, 11 out of 34 patients were highly adherent to oral antibiotic therapy, 22 moderately adherent and 1 poorly adherent. There was no significant change in adherence to antibiotic therapy between W6 and M3. The only variable significantly associated with the level of adherence at W6 and M3 was the number of daily doses of antibiotic (P=0.04 and 0.02 at W6 and M3, respectively). CONCLUSIONS: This study provided a snapshot of patients' adherence in BJI. Adherence to antibiotic therapy appeared to be stable up to 3 months and a higher number of daily doses of antibiotic was associated with poorer adherence. These observations need to be confirmed in future large-scale studies using electronic pill monitoring systems.

Bone cement usage modalities at a multi-site university hospital centre.

BACKGROUND: Although cements are widely used during arthroplasty procedures, few recommendations exist regarding their optimal usage modalities, which, nevertheless, govern the long-term surgical outcomes. No detailed information is available on how cements are used in French hospitals. The objectives of this questionnaire survey among surgeons working at a multi-site university hospital in France were to describe practices, determine whether these varied with surgeon experience, and look for differences compared to recommendations. HYPOTHESIS: Cementing techniques vary widely among surgeons at a university hospital. MATERIAL AND METHODS: A questionnaire was sent to the five orthopaedic departments of our university hospital to collect data on the surgeons (age, sex, years of experience), their practice (type of implants used, annual number of arthroplasties with each arthroplasty type and each indication, and proportion of cemented arthroplasties), the type of cement used, and the cementing technique. RESULTS: Of the 34 surgeons, 21 completed the questionnaire, 20 males and 1 female with a mean age of 41 years (range, 31-59 years) and a mean of 11 years (range, 1-29 years) of experience. High-viscosity antibiotic-loaded cement was preferred by 20 (95%) surgeons, notably for knee arthroplasties, of which the median annual numbers were 55 (range, 0-218) and 8 (range, 1-40) for primary and revision cemented procedures, respectively. Various cementing techniques in ambient air were used: 12/21 (57%) surgeons used pulsed lavage to prepare the bone before cementation and 18/21 (86%) applied the cement to both the bone cuts and the implant. Of the 18 surgeons who performed knee arthroplasties, 12 used pulsed lavage, including 9 of the 11 surgeons with more than 5 years of experience and only 3 of the 7 less experienced surgeons. Similarly, of the 12 surgeons who used pulsed lavage for cemented arthroplasties, 11 were among the 12 surgeons who performed more than 15 cemented arthroplasties annually and 1 was among the 6 who performed fewer cemented arthroplasties. DISCUSSION: Cementing techniques varied widely, reflecting the dearth of recommendations and controversial results of published studies. In our centre, the use of pulsed lavage to improve bone preparation and cement application to both the bone and the implant should be promoted, as both techniques are universally advocated. Our study demonstrates the need to provide surgeons with opportunities to exchange their experiences about the other aspects of cementing in order to harmonise practices and to optimise the use of cement. LEVEL OF EVIDENCE: IV, questionnaire survey.

Sleep Disorders and Therapeutic Management: A Survey in a French Population of Prisoners.

In a French prison, most inmates reported not being satisfied with their sleep. Life habits between good and bad sleepers were not significantly different except for television and smoking. The most frequently reported symptom of insomnia was several awakenings at night, and the most frequently cited etiologies were rumination of thoughts and noise. Most patients reported that their sleeping problems began or worsened after incarceration. A quarter of the inmates were following a hypnotic treatment, and most of these treatments began in prison. Only 42% of patients were satisfied with its effectiveness. These observations enabled us to make recommendations for healthy sleep patterns such as respecting normal night-and-day cycles, encouraging to stop smoking, and promoting appropriate use of hypnotic treatments.

Evaluation of Safe Infusion Devices for Antineoplastic Administration.

Nurses endure daily low-level exposure to cytotoxic drugs, which can lead to significant absorption with potential harmful consequences. New sterile medical devices called cytotoxic safe infusion systems (CSISs), intended by their manufacturers to improve safety and quality of cytotoxic drug infusions, have been made commercially available. CSISs from 3 manufacturers were tested in 2 cancer units and compared with standard infusion sets. The aim of this study is to evaluate the devices regarding occupational exposure, quality of the infusion, and economic aspects.

Evaluation of safe infusion devices for antineoplastic administration.

Nurses endure daily low-level exposure to cytotoxic drugs, which can lead to significant absorption with potential harmful consequences. New sterile medical devices called cytotoxic safe infusion systems (CSISs), intended by their manufacturers to improve safety and quality of cytotoxic drug infusions, have been made commercially available. CSISs from 3 manufacturers were tested in 2 cancer units and compared with standard infusion sets. The aim of this study is to evaluate the devices regarding occupational exposure, quality of the infusion, and economic aspects.