Hypericum and neem oil for dehisced post-surgical wounds: a randomised, controlled, single-blinded phase III study.

OBJECTIVE: To evaluate the clinical efficacy of a hypericum and neem oil dressing, Primary Wound Dressing [ONE] (1PWD) (Kerecis AG, Switzerland), in a patient population with dehiscence of surgical wounds with critical colonisation/infection. Efficacy was defined as resolution of inflammatory/infective symptoms. METHOD: A randomised, controlled, single-blinded, parallel-arms phase III study was conducted comparing the experimental medication to silver-based dressings. All patients were evaluated at enrolment, on days 7, 14, 21 and 28. Improvement of inflammatory/infective symptoms was measured by detecting seven items of the Bates-Jensen Wound Assessment Tool (BWAT). Pain was assessed using the Numeric Rating Scale (NRS). RESULTS: The study enrolled 99 patients. Follow-up was completed in 49 patients in the experimental group and 48 patients in the control group. Overall BWAT evaluation demonstrated similar outcomes between the groups: t=0.23, p-value=0.81, 95% confidence interval (CI): -13.3-10.8. Furthermore, when evaluating the seven items of the BWAT relating to inflammatory signs, there was not a significant difference between the groups: t=0.38, p=0.35, 95% CI: -2.8-2.7. However, when an analysis using the NRS pain scale was performed, a statistically significant pain reduction was demonstrated in favour of the experimental group: t=7.8, p<0.0001, 95% CI: 2.918-4.8819. CONCLUSION: This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing.

Prevalence of pressure ulcers in hospitalised patients: a cross-sectional study.

OBJECTIVE: The main aim of this study was to estimate the prevalence of pressure ulcers (PU) and related risk factors of PU development in hospitalised patients in Italy. Furthermore, the study investigated the association between risk factors for PU present on admission and the development during hospitalisation (hospital-acquired pressure ulcer, HAPU). METHODS: A cross-sectional study, using two separate designs at two separate timepoints: 2010 and 2015. The methodology used to measure PU prevalence was that recommended by the European Pressure Ulcer Advisory Panel (EPUAP). RESULTS: The total sample was 7681 hospitalised patients (3011 patients in 2010, 4670 in 2015). Prevalence of PU in hospital was 19.5% in 2010 and 17% in 2015. The number of patients with PU present on admission were 9.60% in 2010 and 9.42% in 2015. Patients with HAPU were 5.08% in 2010 and 5.87% in 2015. Older age and comorbidities, and a total Braden score of ≤16 were positively associated with PU present on admission and HAPU in hospitals (p<0.05). A longer length of stay appeared to correlate positively with a better clinical outcome for PU if there were already present on admission. Heterogeneous results emerged for length of stay of >30 days and being admitted to intensive care unit (ICU). CONCLUSION: Our results are comparable with other European and Italian studies. Most of the risk factors associated with PU development have been confirmed. However, further studies are needed to examine the effects of context on PU present on arrival and HAPU, especially regarding hospital length of stay.

Improving the quality of clinical research on chronic wound infection treatment: expert-based recommendations.

OBJECTIVE:: To produce recommendations for the design of reliable and informative clinical investigations in chronic wound infection. METHOD:: A multidisciplinary panel of international experts from four countries (Italy, UK, Ireland and the US) were involved in a detailed, semi-structured discussion on how to better select and describe a target population, interventions and outcomes, and which infection-related criteria to apply in order to achieve a high-quality trial. Consent among the experts was measured using the Delphi method and GRADE Working Group suggestions. The project was fully supported by AISLeC 2016 (Italian Nursing Society for Wound Care Study). RESULTS:: In total, 37 recommendations achieved substantial agreement among the experts; 10 concerned the most appropriate description and selection of a target population, four related to interventions and 15 to outcomes. A further eight statements about critical methodological points were approved. CONCLUSION:: Developing recommendations in a systematic manner through a representative group of experts could generate tools for improving the design of clinical trials in this challenging area.

Design and validation of a "Peristomal Lesion Scale" for peristomal skin assessment.

Many people in Italy undergo ostomy because of illness, and this can have negative psychological and physical effects. It is estimated that 15%-43% of ostomates suffer from skin complications in the peristomal area. During their life, many ostomates experience at least one peristomal lesion, and they turn to stomal therapy centres where trained nurses provide patient care and manage skin complications. To ensure a good quality of life for patients, and to take prompt action for the prevention and treatment of stomal lesions, it is essential to use appropriate assessment tools. The aim of this study was to develop a reliable peristomal skin assessment tool (Peristomal Lesion Scale [PLS]) for classifying lesions based on their severity; and to compare its validity with the most widely used peristomal tool in Italy, SACS. The new tool was designed by a team of experts, focusing on patients' demographics, clinical characteristics, and classification of the lesions by severity and topography. The results of this comparative validation study indicate that the PLS better discriminates lesions by their severity because of its level of detail, using a standardised terminology, and its completeness. The PLS is a valid tool for use in the daily work of stomal therapists.

[Multicentre, prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of the pressure sores in newborns and up to 8 years old children]. / Studio di coorte prospettico multicentrico per la validazione italiana della Braden Q per la valutazione del rischio di lesioni da decubito nei neonati e nei bambini fino ad 8 anni.

UNLABELLED: Multicenter prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of pressure sores in newborns and up to 8 years old children. INTRODUCTION: Children admitted to Intensive care Units (ICU), oncology and neurology/neurosurgery wards are at risk of developing pressure sores. AIM: To validate the Italian version of the Braden Q scale for the assessment of the risk of developing pressure sores in children. METHODS: Children from 21 days to 8 years, admitted to intensive and sub intensive units were recruited. Premature babies, children admitted with a pressure sore and with a story of congenital cardiomiopathy were excluded. In this cohort, multicentre and with repeated measurements study, the first assessment was performed after 24 hours from hospital admission, using the Braden Q Scale (Suddaby's version). The pressure sores were assessed with the Skin assessment Tool and staged according to the National Pressure Ulcer Advisory Panel. RESULTS. On the 157 children 524 observation were conducted. The incidence of pressure sores was 17.2%. Only the analysis on specific subgroups of patients showed a good diagnostic accuracy: 71.4% on children 3-8 years; 85.6% in sub intensive wards. CONCLUSIONS: The Braden Q scale may be reliably used and shows a good diagnostic accuracy in children 3-8 years of age admitted to sub-intensive, neurology, oncology and heamatology wards.

Pillars for prevention and control of healthcare-associated infections: an Italian expert opinion statement.

Healthcare-associated infections (HAIs) represent a relevant problem for all healthcare facilities, because they involve both the care aspect and the economic management of the hospital. Most HAIs are preventable through effective Infection Prevention and Control (IPC) measures. Implementation and improvement of IPC programs are critical to reducing the impact of these infections and the spread of multi-resistant microorganisms. The purpose of this Expert Opinion statement was to provide a practical guide for healthcare organizations, physicians, and nursing staff on the optimal implementation of the core components of Infection Prevention and Control, as recommended by a board of specialists after in-depth discussion of the available evidence in this field. According to their independent suggestions and clinical experiences, as well as evidence-based practices and literature review, this document provides a practical bundle of organizational, structural, and professional requirements necessary to promote, through multimodal strategies, the improvement of the quality and safety of care with respect to infectious risk in order to protect the patient, facilities, and healthcare providers.

Measuring disability of women with systemic sclerosis: validation of the italian version of the systemic sclerosis questionnaire.

BACKGROUND: The aim of this study was to validate the Italian version of Systemic Sclerosis Questionnaire (SySQ) and to evaluate its psychometric characteristics on a sample of inpatient and outpatient women with systemic sclerosis (SSc). METHODS: Internal and external validity of the Italian version of SySQ were analyzed. Internal validity included: 1) construct validity by means of factor analysis; 2) internal consistency for each category of SySQ through Cronbach's alpha; and 3) reproducibility over time with test-retest using both Pearson's correlation and Intraclass Correlation Coefficient. External validity included: 1) concurrent validity, i.e. correlation with Skindex-17; and 2) discriminant validity, through comparison of scores for different groups of patients. RESULTS: We obtained data on 115 patients with SSc: 68 had the limited clinical form (lSSc) and 47 had the diffuse clinical form (dSSc). The structure of SySQ was confirmed by factor analysis. The questionnaire showed optimal internal consistency for all SySQ categories (Cronbach's alpha >0.84) and very good reproducibility over time (0.79-0.93, P<0.001). Regarding external validity, SySQ showed good correlation with Skindex-17 (P<0.01) and a satisfactory power of discrimination between groups affected by different clinical conditions. CONCLUSIONS: The study confirmed that the SySQ maintains good psychometric properties also in a language different from the original. It is a disease-specific tool that can be routinely used in clinical practice for the evaluation of the level of disability in patients with SSc.