Background: Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. Methods:We randomised 2970 patients from 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were ≥45 years of age were eligible. Patients were randomly assigned to accelerated surgery (goal of surgery within 6 hours of diagnosis; 1487 patients) or standard care (1483 patients). The co-primary outcomes were 1.) mortality, and 2.) a composite of major complications (i.e., mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Outcome adjudicators were masked to treatment allocation, and patients were analysed according to the intention-to-treat principle; ClinicalTrials.gov, NCT02027896. Findings:The median time from hip fracture diagnosis to surgery was 6 hours (interquartile range [IQR] 4-9) in the accelerated-surgery group and 24 hours (IQR 10-42) in the standard-care group, p<0.0001. Death occurred in 140 patients (9%) assigned to accelerated surgery and 154 patients (10%) assigned to standard care; hazard ratio (HR) 0.91, 95% CI 0.72-1.14; absolute risk reduction (ARR) 1%, 95% CI -1-3%; p=0.40. The primary composite outcome occurred in 321 patients (22%) randomised to accelerated surgery and 331 patients (22%) randomised to standard care; HR 0.97, 95% CI 0.83-1.13; ARR 1%, 95% CI -2-3%; p=0.71.Interpretation: Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared to standard care.

Aim of study The main objective of this study was to ascertain whether severe alterations in hypoxemic, inflammatory, and nutritional parameters in patients diagnosed with SARS-CoV-2 infection were associated with the occurrence and severity of developed dependency-related injuries. The secondary objective was to determine whether there were prognostic factors associated with the occurrence and severity of developed dependency-related injuries during the SARS-CoV-2 pandemic. Material and Methods A retrospective, single-centre, case-control study was conducted to compare SARS-CoV-2 patients who developed dependency-related injuries after the first 48 hours after admission with a control group made up of SARS-CoV-2 patients without dependency-related injuries. The cases of the 1,987 patients diagnosed with SARS-CoV-2 infection during the study period were reviewed. Data from 94 patients who developed dependency-related injuries and from 190 patients who did not develop them during hospital admission were analysed. Results High baseline dependency levels, prolonged hospital stays, and low oxygen saturation levels on arrival in emergency department triage were associated with the occurrence of dependency-related injuries among patients diagnosed with SARS-CoV-2 infection. Conclusions SARS-CoV-2 infection can lead to complications such as dependency-related injuries. Although there are several non-modifiable variables associated with the occurrence of dependency-related injuries in these patients, it is essential to conduct further research and introduce consensus guidelines to reduce their incidence and prevalence.

BackgroundSurgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Some of the newest dressings have been shown to reduce the incidence of blisters compared with traditional dressing or colloid adhesive dressings. However, there are no comparative evaluations between the different types of dressings and their contribution to the overall results of the healing process.Methods/designThis is a randomized, controlled, open-label trial to compare five types of dressings used in total knee and hip arthroplasty surgical wounds. A total of 550 patients will be randomly allocated to one of the following dressings: (1) traditional occlusive dressing, (2) Aquacel Surgical®, (3) Mepilex® Border Post-Op, (4) OpSite Post-Op Visible, or (5) UrgoTul® Absorb Border. The dressing assigned is placed right after surgery. Patients will be followed up to 14 days after surgery when the dressing is definitively removed and will be tracked up to 3 months to record any late complications. During the immediate postoperative period and patient hospitalization and at the ambulatory visits after discharge, every time that the dressing is changed, nurses perform the study assessments. The main study outcome will be the percentage of patients with skin integrity at all times when the dressing has been changed. Skin integrity is a composite of the absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates. Secondary outcomes include time to first change of dressing; percentage of patients with presence/absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates; number of dressing changes needed; days of hospital stay; and nurse and patient satisfaction.Differences in the main variable between each treatment group and group 1 will be tested by means of a chi-squared test or Fisher’s exact test. Subgroup analyses of diabetic and non-diabetic patients, patients with a body mass index of more than 30 or not more than 30, and type of surgery (hip or knee) are planned.DiscussionThe results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients.Trial registrationThis trial has been registered at ClinicalTrials.gov (NCT03190447). Retrospectively registered on 16 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2755-8) contains supplementary material, which is available to authorized users.

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The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.

Background: The awareness that research is essential to improve evidence based-care has increased among nursing professionals. When implementing experimental studies, ethical principles must go first among them, the need for the Informed Consent (IC) of subjects participating in research, thus ensuring that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical in elective prosthetic surgery. Obtaining IC for a clinical trial is not without difficulties, especially in the case of vulnerable populations, comprehension problems, under-literacy of subjects and factors associated with senility can be very challenging.Aim: To identify the difficulties during information and obtaining Informed Consent (IC) to participate in a clinical trial in subjects older than 65 years old and to quantify and describe the use of IC in front of a witness. Methods: Mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC. Results: The main difficulties identified are related to comprehension, sensory impairments, education level and time. IC in front of witnesses was used in 17 patients out of 391. Conclusion: The participation of subjects older than 65 years in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.