Research from JAMA — Supplemental Perioperative Oxygen and the Risk of Surgical Wound Infection — A Randomized Controlled Trial — ContextSupplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.ObjectiveTo test the hypothesis that supplemental oxygen reduces infection risk in patients following colorectal surgery.Design, Setting, and PatientsA double-blind, randomized controlled trial of 300 patients aged 18 to 80 years who underwent elective colorectal surgery in 14 Spanish hospitals from March 1, 2003, to October 31, 2004. Wound infections were diagnosed by blinded investigators using Centers for Disease Control and Prevention criteria. Baseline patient characteristics, anesthetic treatment, and potential confounding factors were recorded.InterventionsPatients were randomly assigned to either 30% or 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.Main Outcome MeasuresAny surgical site infection (SSI); secondary outcomes included return of bowel function and ability to tolerate solid food, ambulation, suture removal, and duration of hospitalization.ResultsA total of 143 patients received 30% perioperative oxygen and 148 received 80% perioperative oxygen. Surgical site infection occurred in 35 patients (24.4%) administered 30% FIO2 and in 22 patients (14.9%) administered 80% FIO2 (P=.04). The risk of SSI was 39% lower in the 80% FIO2 group (relative risk [RR], 0.61; 95% confidence interval [CI], 0.38-0.98) vs the 30% FIO2 group. After adjustment for important covariates, the RR of infection in patients administered supplemental oxygen was 0.46 (95% CI, 0.22-0.95; P = .04). None of the secondary outcomes varied significantly between the 2 treatment groups.ConclusionsPatients receiving supplemental inspired oxygen had a significant reduction in the risk of wound infection. Supplemental oxygen appears to be an effective intervention to reduce SSI in patients undergoing colon or rectal surgery.Trial RegistrationClinicalTrials.gov Identifier: NCT00235456

Opiate addiction affects young adults whose life expectancy is reduced as a consequence of their habit. In the midst of the AIDS epidemic, the present study objective was to analyse recent overall and cause-specific mortality trends among opiate addicts in Catalonia (Spain). Mortality was assessed retrospectively in an opiate addict cohort assembled from admissions to hospital emergency wards and drug treatment centres during the period 1985–1991. The cohort included 15 711 opiate addicts (12 045 men and 3666 women) aged 15–44 years. Overall and cause-specific mortality trends were analysed using age as the time scale and Cox regression with staggered entry determined by the age at entry in the study. Annual trends we’re adjusted by sex and source of entry, and were stratified by length of opiate use. Mortality rates increased throughout the entire period from 13.8 to 34.8 deaths per 1000 person-years, with a statistically significant increase in 1987–1988 and 1988–1989. In a model including age, gender, source of entry and length of drug use, risk increased significantly in men and for longer length of use, but not with age and for source of entry into the study cohort. The causes of death associated with high mortality rates were AIDS and the causes directly related to addiction. A threefold increase in mortality rates was observed during the period, mainly accounted for by AIDS and direct addiction-related causes. Length of opiate use was an important determinant of mortality

A SARS-CoV-2 protein-based heterodimer vaccine, PHH-1V, has been shown to be safe and well-tolerated in healthy young adults in a first-in-human, Phase I/IIa study dose-escalation trial. Here, we report the interim results of the Phase IIb HH-2, where the immunogenicity and safety of a heterologous booster with PHH-1V is assessed versus a homologous booster with BNT162b2 at 14, 28 and 98 days after vaccine administration. The HH-2 study is an ongoing multicentre, randomised, active-controlled, double-blind, non-inferiority Phase IIb trial, where participants 18 years or older who had received two doses of BNT162b2 were randomly assigned in a 2:1 ratio to receive a booster dose of vaccine —either heterologous (PHH-1V group) or homologous (BNT162b2 group)—in 10 centres in Spain. Eligible subjects were allocated to treatment stratified by age group (18–64 versus ≥65 years) with approximately 10% of the sample enrolled in the older age group. The primary endpoints were humoral immunogenicity measured by changes in levels of neutralizing antibodies (PBNA) against the ancestral Wuhan-Hu-1 strain after the PHH-1V or the BNT162b2 boost, and the safety and tolerability of PHH-1V as a boost. The secondary endpoints were to compare changes in levels of neutralizing antibodies against different variants of SARS-CoV-2 and the T-cell responses towards the SARS-CoV-2 spike glycoprotein peptides. The exploratory endpoint was to assess the number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster. This study is ongoing and is registered with ClinicalTrials.gov, NCT05142553. From 15 November 2021, 782 adults were randomly assigned to PHH-1V (n = 522) or BNT162b2 (n = 260) boost vaccine groups. The geometric mean titre (GMT) ratio of neutralizing antibodies on days 14, 28 and 98, shown as BNT162b2 active control versus PHH-1V, was, respectively, 1.68 (p < 0.0001), 1.31 (p = 0.0007) and 0.86 (p = 0.40) for the ancestral Wuhan-Hu-1 strain; 0.62 (p < 0.0001), 0.65 (p < 0.0001) and 0.56 (p = 0.003) for the Beta variant; 1.01 (p = 0.92), 0.88 (p = 0.11) and 0.52 (p = 0.0003) for the Delta variant; and 0.59 (p ≤ 0.0001), 0.66 (p < 0.0001) and 0.57 (p = 0.0028) for the Omicron BA.1 variant. Additionally, PHH-1V as a booster dose induced a significant increase of CD4⁺ and CD8⁺ T-cells expressing IFN-γ on day 14. There were 458 participants who experienced at least one adverse event (89.3%) in the PHH-1V and 238 (94.4%) in the BNT162b2 group. The most frequent adverse events were injection site pain (79.7% and 89.3%), fatigue (27.5% and 42.1%) and headache (31.2 and 40.1%) for the PHH-1V and the BNT162b2 groups, respectively. A total of 52 COVID-19 cases occurred from day 14 post-vaccination (10.14%) for the PHH-1V group and 30 (11.90%) for the BNT162b2 group (p = 0.45), and none of the subjects developed severe COVID-19. Our interim results from the Phase IIb HH-2 trial show that PHH-1V as a heterologous booster vaccine, when compared to BNT162b2, although it does not reach a non-inferior neutralizing antibody response against the Wuhan-Hu-1 strain at days 14 and 28 after vaccination, it does so at day 98. PHH-1V as a heterologous booster elicits a superior neutralizing antibody response against the previous circulating Beta and the currently circulating Omicron BA.1 SARS-CoV-2 variants in all time points assessed, and for the Delta variant on day 98 as well. Moreover, the PHH-1V boost also induces a strong and balanced T-cell response. Concerning the safety profile, subjects in the PHH-1V group report significantly fewer adverse events than those in the BNT162b2 group, most of mild intensity, and both vaccine groups present comparable COVID-19 breakthrough cases, none of them severe. HIPRA SCIENTIFIC, S.L.U.

Background: Clinical safety is a crucial component of healthcare quality, focused on identifying and avoiding the risks to which patients are exposed. Among the adverse events that occur in a hospital environment, falls have a large impact (1.9–10% of annual income in acute care hospitals); they can cause pain, damage, costs, and mistrust in the health system. Our objective was to assess the effect of an educational intervention aimed at hospital nurses (systematic assessment of the risk of falls) in reducing the incidence of falls. Methods: this was a quasi-experimental study based on a sample of 581 patients in a third level hospital (Comunitat Valenciana, Spain). An educational program was given to the intervention group (n = 303), and a control group was included for comparison (n = 278). In the intervention group, the nurses participated in a training activity on the systematized assessment of the risk of falls. Analysis was undertaken using the Bayesian logistic regression model. Results: a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years. The overall incidence of falls was 1.2% (0.3% in the intervention group and 2.2% in the control group). Most of the falls occurred in people ≥65 years old (85.7%). The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013–0.821). Neither the length of hospital stay, nor the age of the participants, had any relevant effect. Conclusions: the systematic assessment of the risk of a patient falling during hospital processes is an effective intervention to reduce the incidence of falls.

HAIs remain a frequent complication for hospitalised patients and pose a challenge that must be tackled by our health systems. Quasi-experimental study. In order to determine the antimicrobial effectiveness of surface coating agents containing silver ions (BactiBlock®) the degree of contamination of several surfaces in two ICU wards was compared. The association between application of Bactiblock® and surface contamination was analysed using a relative risk (RR). Multivariate logistic regressions were performed for each product applied and each sampling location to adjust for the RR of the contamination of surfaces treated with Bactiblock® for the independent variables. Surface contamination was observed in 31.5% of treated samples and 27.4 of untreated samples. Contamination was equally prominent on bedside Tables (38.7%), bed rails (38.4%) and sinks (38.3%), while the walls showed minimum contamination (2.6%). For beds under isolation protocols, contamination was higher (32.6%) than when no protocol was followed (26.5%) but the difference was not significant (p = 0.148). After stratification for application method and adjusting the multivariate models for period of the study and presence of isolated patients, the risk of contamination after the intervention increased when the coating agent was applied using a spray (OR = 1.79; 95% CI: 1.08-2.95, particularly in a dry and rugged surface such as that of bedside Tables (OR = 2.59; 95% CI: 1.22-5.52); and decreased when the product was applied using a roller on a smooth and continuously cleaned (or wet) Surface (OR = 0.42; 95% CI: 0.19-0.92). Coating of hospital surfaces with substances containing silver ions may reduce bacterial growth. However, the effectiveness of the coating agent is affected by application method and environmental conditions and the type and cleanness of the surface.