A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).

BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids. METHODS: A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year. RESULTS: There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Healthcare personnel and hand decontamination in intensive care units: knowledge, attitudes, and behaviour in Italy.

The purpose of this study was to evaluate knowledge, attitudes, and behaviour regarding hand decontamination in personnel of intensive care units (ICUs) in Italy. All ICU physicians and nurses in 19 and five randomly selected hospitals in Campania and Calabria (Italy) were mailed a questionnaire focusing on demographics and practice characteristics; knowledge about prevention of hospital acquired infection; attitudes and behaviour with respect to hand decontamination; and use of gloves. A total of 413 questionnaires were returned giving a response rate of 66.6%. Overall, 53.2% agreed with the correct responses on knowledge related to infection control, and this knowledge was significantly higher in neonatal and medicine-surgery wards and in larger ICUs. A positive attitude was reported by the large majority who agreed that hand decontamination reduces the risk of infection in patients (96.8%) and personnel (86.2%), and the positive attitude was significantly higher among older and female personnel and in those with a higher level of knowledge. Only 60% always decontaminate hands at the start of a shift, and 72.5% before and after a patient contact. Higher compliance is reported for invasive manoeuvres, such as urinary catheters (96.5%) and intravenous lines (77.1%). Routine hand decontamination between each patient was significantly higher in females, and in neonatal and medicine-surgery ICUs. Our results suggest that interventions should not only be focused on predisposing factors (knowledge), but also on enabling (facilitating) and reinforcing (gratifying) factors.