Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers : a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial

Background: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital‐acquired pressure ulcers (PUs). Objectives: Determine if silicone foam dressings in addition to standard prevention reduce PU incidence category 2 or worse compared to standard prevention alone. Methods: Multicentre, randomised controlled, medical device trial conducted in eight Belgian hospitals. At risk adult patients were centrally randomised (n=1633) to study groups based on a 1:1:1 allocation: experimental group 1 (n=542) and 2 (n=545) ‐ pooled as the treatment group ‐ and the control group (n=546). Experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on these body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU category 2 or worse at these body sites. Results: In the intention‐to‐treat population (n=1605); 4.0% of patients developed PUs category 2 or worse in the treatment group and 6.3% in the control group (RR=0.64, 95% CI 0.41 to 0.99, P=0.04). Sacral PUs were observed in 2.8% and 4.8% of the patients in the treatment group and the control group, respectively (RR=0.59, 95% CI 0.35 to 0.98, P=0.04). Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49). Conclusions: Silicone foam dressings reduce the incidence of PUs category 2 or worse in hospitalised at‐risk patients when used in addition to standard of care. Results show a decrease for sacrum, but no statistical difference for heel/trochanter areas

Pressure ulcer cat. II‐IV incidence on the CuroCell S.A.M. PRO powered reactive air support surface in a high‐risk population : a multicentre cohort study in 12 Belgian nursing homes

The primary objective was to study pressure ulcer (PU) category II-IV (including suspected deep tissue injury and unstageable PUs) cumulative incidence and PU incidence density, in a 30day observation period, associated with the use of the CuroCell S.A.M. PRO powered reactive air support surface in nursing home residents at risk for PU development. Secondary objectives were to study (a) PU category I cumulative incidence and PU incidence density and (b) user (caregivers and residents) experiences and perceptions of comfort associated with the use of the support surface under study. A multicentre cohort study was set up in 37 care units of 12 Belgian nursing homes. The sample consisted of 191 residents at risk of PU development (Braden score <= 17). The cumulative PU incidence was 4.7% (n = 9). The PU incidence density was 1.7/1000 observation days (9 PU/5370days). The experience and perceptions of comfort analysis revealed that the CuroCell S.A.M. PRO powered reactive air support surface was comfortable for daily use. The mode of action and the quietness of the pump function had a positive impact on sleep quality. Patient comfort and sleep quality are essential criteria in the selection of a support surface

Development and psychometric validation of PUKAT 2.0, a knowledge assessment tool for pressure ulcer prevention

The aim of this study was to develop a tool to measure the knowledge of nurses on pressure ulcer prevention. PUKAT 20 is a revised and updated version of the Pressure Ulcer Knowledge Assessment Tool (PUKAT) developed in 2010 at Ghent University, Belgium. The updated version was developed using state-of-the-art techniques to establish evidence concerning validity and reliability. Face and content validity were determined through a Delphi procedure including both experts from the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) (n = 15). A subsequent psychometric evaluation of 342 nurses and nursing students evaluated the item difficulty, discriminating power and quality of the response alternatives. Furthermore, construct validity was established through a test-retest procedure and the known-groups technique. The content validity was good and the difficulty level moderate. The discernment was found to be excellent: all groups with a (theoretically expected) higher level of expertise had a significantly higher score than the groups with a (theoretically expected) lower level of expertise. The stability of the tool is sufficient (Intraclass Correlation Coefficient = 069). The PUKAT 20 demonstrated good psychometric properties and can be used and disseminated internationally to assess knowledge about pressure ulcer prevention

A fully automated pulsating support system for pressure injury prevention and treatment in 10 Belgium nursing homes : an observational study

PURPOSE: We studied pressure injury (PI) stage II-IV cumulative incidence and the change of PI status in the sacral area of nursing home residents associated with the use of a fully automated pulsating support system air mattress in use for 30 days. We also assessed caregivers', residents', and their family members' experiences and perceptions of mattress comfort and other factors such as pain. DESIGN: Multicenter cohort study. SUBJECT AND SETTING: A convenience sample of 40 residents residing in 10 Belgian nursing homes was recruited. METHODS: Pressure injury classification was confirmed using the European Pressure Ulcer Advisory Panel classification system. The Pressure Ulcer Scale for Healing (PUSH) tool was used to assess and measure PI status change. A comfort assessment was performed at end of the study. Cumulative PI incidence of stages II-IV was calculated, and frequencies and percentages were used to describe the results of the comfort assessments. RESULTS: Residents were allocated to the prevention group (n = 22) and to the treatment group (n = 18). The cumulative PI incidence was 4.5% (n = 1/22) in the prevention group. In the treatment group, the mean score on the PUSH tool decreased from 9.36 to 7.70 during the observation period, indicating an overall improvement. Four of the existing PIs healed, 17 PIs remained stable, and 1 PI deteriorated. The comfort questionnaires were completed by 76 nursing home caregivers, 21 family members, and 11 residents in the 10 participating nursing homes; the mattress comfort was perceived as very good, and pain was noted to decrease. CONCLUSIONS: Low cumulative PI incidence findings were observed with use of the mattress for the prevention of PIs and resulted in improvements in existing PIs, results which are consistent with several existing studies. The majority of the caregivers, residents, and family members evaluated the mattress as comfortable. Future research is needed to corroborate findings in larger randomized clinical trials