Background Major trauma is the leading cause of death in people aged < 45 years. Patients with major trauma usually have lower-limb fractures. Surgery to fix the fractures is complicated and the risk of infection may be as high as 27%. The type of dressing applied after surgery could potentially reduce the risk of infection. Objectives To assess the deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use in patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with incisional negative-pressure wound therapy versus standard dressings. Design A pragmatic, multicentre, randomised controlled trial. Setting Twenty-four specialist trauma hospitals representing the UK Major Trauma Network. Participants A total of 1548 adult patients were randomised from September 2016 to April 2018. Exclusion criteria included presentation > 72 hours after injury and inability to complete questionnaires. Interventions Incisional negative-pressure wound therapy (n = 785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure (n = 763). Trial participants and the treating surgeon could not be blinded to treatment allocation. Main outcome measures Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery. Results A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50/749) in the standard dressing group and 5.8% (45/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33; p = 0.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19; p = 0.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness. Limitations Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma. Conclusions The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs. Future work Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture. Trial registration Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 38. See the NIHR Journals Library for further project information.

Nutrition-related studies avoid the participation of pre-menopausal women due to the potential effect of the menstrual cycle (MC) on their appetite regulation. It is generally accepted that women increase their energy intake during the luteal phase (LPh) compared to the follicular (FPh), however what happens in the menstrual phase (MPh) and how this might be regulated remains uncertain. Although some research indicates changes in the gastric emptying (GE) velocity, whether PYY is affected by the MC phase, remains unknown. The aim of this study was to assess whether eating the same breakfast in each of the three MC phases would change the GE time, the PYY response and post-prandial satiety such that they might affect subsequent food intake. Furthermore, the aim was to associate any potential differences to the fluctuations in estradiol (E) and progesterone (P) within a MC. Nine naturally cycling women attended to the laboratory to consume a standardised breakfast on three occasions, each of them representing one of the MC phases. Breath samples to measure GE time, plasma samples to quantify PYY levels and hunger scores were collected for a total of 4 h after which food intake was assessed by an ad-libitum buffet lunch. GE and PYY levels changed significantly across the phases of the MC (p < 0.05). GE was correlated to P and E-P ratio (r = -0.5 and 0.4, respectively). To conclude, the appetite regulators PYY and GE time change depending upon the MC phases with GE time associated with the ovarian hormone levels which suggests the necessity of controlling the MC phase in studies looking at the appetite response.

Purpose The COVID-2019 pandemic forced many governments to declare the “to stay at home” which encouraged social distancing and isolation among citizens. The aim of this study was to assess the dietary and lifestyle habit changes that occurred during home confinement in Spain. Methods An European online survey was launched in April 2020. This included 70 questions on sociodemographic characteristics, lifestyle, dietary habits, including key Mediterranean diet (MedDiet) foods. A total of 945 Spanish adults from 1268 European that completed the online survey were included in the analysis. Results Most of the Spanish participants adopted healthier dietary habits during home lockdown, which was translated to a higher MedDiet adherence. However, a negative impact on physical activity levels, sleep quality or smoking rates was observed. Low MedDiet adherence was associated with a higher risk of weight gain (OR = 1.53, CI 1.1–2.1; p = 0.016), while no snacking between meals reduced the risk by 80% (OR = 0.20, CI 0.09–0.45, p < 0.001) and eating more quantity, considering portion size, increased body weight gain risk almost sixfold more. Conclusion To conclude, although dietary habits were improved during home lockdown, certain unhealthy behaviours (e.g. increased snacking between meals, increased food intake, and an increase in sedentary behaviour) were increased.